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Precision Medicine Patient Navigator Location: Remote Function: Clinical/Oncology Preferred Experience- Oncology About the Role As a Precision Medicine Navigator, you will be the patient's advocate and play a crucial role in coordinating and supporting patients enrolled in precision medicine programs. Your responsibilities will include outreach, patient intake, guiding them through the precision medicine process, and ensuring the seamless delivery of personalized healthcare solutions. Key Responsibilities • Conduct comprehensive assessments of patients to confirm their eligibility and potential benefits from precision medicine programs., • Collaborate with scientists and clinicians to deliver treatment strategy reports to patients and physicians., • Provide patients and their families with information about precision medicine, including the benefits, risks, and expectations., • Act as the central point of contact for patients, coordinating appointments, tests, consultations, and treatment plans., • Assist patients in obtaining and understanding the implications of diagnostic testing and provide emotional support and guidance., • Facilitate enrollment in relevant clinical trials and research studies for eligible patients., • Maintain accurate and confidential patient records, including genetic and clinical data, and ensure compliance with privacy regulations., • Continuously monitor patient progress, track outcomes, and provide ongoing support and care management., • Connect patients to resources, support groups, and community organizations to enhance their care and quality of life., • Serve as a liaison between patients, healthcare providers, and other care team members to ensure clear and effective communication., • Advocate for patients' needs, preferences, and concerns to ensure their voices are heard in the healthcare decision-making process., • Ensure that precision medicine services meet the highest quality standards and adhere to industry regulations. Qualifications • Certification as a Care Manager, Social Worker, Genetic or Molecular Counselor, or equivalent is highly desirable., • Proven experience in patient care, case management, or care coordination in a clinical or healthcare setting., • Knowledge of precision medicine concepts, genetic testing, and clinical trial processes is preferred., • Strong interpersonal and communication skills to effectively interact with patients, healthcare providers, and interdisciplinary teams., • Compassion and empathy for patients and their families., • Organizational skills and attention to detail for coordinating complex care plans and administrative tasks., • Understanding of healthcare data privacy and security regulations., • Ability to work in a fast-paced and evolving healthcare technology environment. Success Metrics • Patient satisfaction score ≥ 90% on post-engagement surveys, reflecting trust, understanding, and emotional support., • ≤ 5% of patient drop-offs after intake, demonstrating effective engagement and retention., • Navigator caseload is maintained within an optimal range of 50 active patients to ensure personalized care and responsiveness., • ≥ 90% of patient cases documented with full, compliant notes in Medzownʼs platform (no missing data fields)., • 100% adherence to Medzownʼs documentation, data integrity, and consent procedures. Medzown is transforming the way patients with cancer and other complex or rare diseases access life-changing treatments. Our mission-driven platform combines deep clinical expertise, advanced technology, and data science to deliver personalized treatment strategies—including clinical trials—to help patients find the right treatment at the right time. We donʼt just guide patients—we advocate for them every step of the way. Join us in shaping the future of precision medicine and making a real difference in peopleʼs lives. Medzown is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based on race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, genetic information, marital status,amnesty, or status as a covered veteran under applicable federal,state, and local laws. All qualified applicants will be considered for employment without regard to these or any other characteristics protected by law.

Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives! We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. We are actively hiring Bilingual Clinical Research Coordinators at our Little Havana, Miami location! The Clinical Research Coordinator assists the Investigators in executing Phase I, II, III, and IV clinical research trials in accordance with Standard Operating Procedures (SOPs), FDA and GCP guidelines, and study protocols while providing an impeccable patient experience in every, single interaction. Shift: Monday-Friday, 8 AM - 4:30 PM (occasional weekends) Location: 2128 W Flagler St 1st Floor, Miami, FL 33135 Compensation: Competitive hourly base compensation Benefits: Health, dental, and vision insurance plans, 401k with 4% match, tuition reimbursement, parental leave, referral program, employee assistance program, life insurance, disability insurance, and 15 days of PTO + 10 company holidays. RESPONSIBILITIES • The Clinical Research Coordinator (CRC) obtains study participant informed consent., • Executes study protocol procedures in a detailed, organized, and professional manner., • Performs human specimen lab draws and processing, and packages specimen shipments., • Creates and completes study source documents and adverse event reporting on an e-source system., • Maintains study-specific files and supplies., • Communicate with the Study Sponsor/CRO regarding study-specific questions., • Participates in site visits from Sponsors/CROs, including site initiation and monitoring visits., • Additional duties as assigned by management. QUALIFICATIONS • Bachelor's degree preferred, but not required, • Phlebotomy experience is required; EKG or other patient labs/processes preferred, • Preferably 2+ years of experience as a Clinical Research Coordinator, • Familiar with e-source reporting via an electronic platform, • A clear understanding of ICH, FDA, and GCP regulations, • Impeccable organizational skills and attention to detail, • Excellent communication and interpersonal skills to effectively interact with the Principal Investigator, research team, Study Sponsor/CROs, potential subjects, and referral sources, • An ethical compass that compels the candidate to be honest, detail-oriented, and self-driven, • High-level critical thinking skills, • Working knowledge of medical terminology and lab collection/processing/storage procedures, • Proficiency with computers and Microsoft Office Suite Flourish Research offers an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. Apply today to learn more about how you can join us in our mission to save and improve the lives of others! Flourish Research is where clinical trials thrive. Flourish Research represents one of the industry's most progressive and diversified clinical trial companies with robust capabilities in the therapeutic areas of cardiology/metabolic disorders/renal, CNS, pulmonology, and vaccines. At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality. Flourish Research is driven by a diverse and inclusive community of passionate people who are committed to improving the quality of life of communities around the world. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect. Flourish Research strives to build an organization that attracts and leverages diversity in our staff, which reflects the diversity of our local communities. We promote education, acceptance, and inclusion because there is beauty in diversity. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU! It is the policy of Flourish Research not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status.

Advanced Practice Provider Opportunity Hematology Oncology Associates of the Palm Beaches Palm Beach County, FL Job Details: Occupation: Nurse Practitioner or Physician Assistant Specialty: Hematology/Oncology Clinic Location: Palm Beach County, FL Employment: Full-Time | Mon-Fri Opportunity: Private Practice, Outpatient Board Certifications: NP-C/PA-C Ideal Candidate: • 1-2 years of NP/PA experience required, • Hematology/Oncology experience as RN or APP required About the Role: Hematology Oncology Associates of the Palm Beaches is seeking a dedicated and compassionate Advanced Practice Provider to join our private practice in Palm Beach County, Florida. The APP will rotate between two of our three locations in Lake Worth, Boynton Beach, and Loxahatchee. Working as part of a collaborative, patient-focused team, the APP will provide high-quality care to individuals undergoing hematology and oncology treatment, assist in developing and managing treatment plans, conduct follow-up visits, and support the practice’s mission of delivering exceptional, compassionate cancer care throughout the community. About the Area: Located along Florida’s scenic southeastern coast, Palm Beach County offers a vibrant blend of coastal living, cultural attractions, and year-round sunshine. The area is home to beautiful beaches, top-rated schools, world-class dining, and an active outdoor lifestyle with endless opportunities for boating, golf, and community events. With diverse neighborhoods from the lively downtowns of West Palm Beach and Delray Beach to the relaxed, family-friendly suburbs, Palm Beach County provides an exceptional quality of life for professionals and families alike. Recruitment Package: • Top-Tier Compensation: Benefit from highly competitive compensation structures. Exact compensation may vary based on skills, experience, and location., • Professional Growth: Enjoy CME reimbursement to further your education and skills., • Comprehensive Benefits: Robust benefit package, reviewed annually to stay competitive with the market. This includes Medical, Dental, Vision, Short-Term and Long-Term Disability, Life, and Accidental Death coverage., • Secure Your Future: We offer comprehensive, flexible, and competitive retirement savings options., • Work-Life Balance: Paid time off, to ensure you maintain a healthy work-life balance., • Community Care: Make a real difference by caring for patients in their local communities., • Supportive Environment: Join a group of specialized APPs that value clinical autonomy, work-life balance, and quality patient care while prioritizing your professional development and well-being. About the Practice and their Mission: Hematology Oncology Associates of the Palm Beaches was established in Palm Beach County over 35 years ago and has grown to include 7 Board Certified Hematologists and Oncologists in 3 convenient locations. Our goals are to provide state-of-the-art cancer treatments with a high level of compassionate care in a warm inviting environment. We also specialize in the treatment of coagulation blood disorders, leukemias, and other hematologic benign conditions. Hematology Oncology Associates of the Palm Beaches is a proud partner of OneOncology. OneOncology is a nationwidepartnership of leading independent community oncology practices working together to improve the lives of everyone living with cancer with a physician-led, data-driven, technology-powered, and patient-centric model. Through OneOncology, partner practices have shared technology platforms that foster communication, data sharing, and clinical excellence across the network. OneOncology’s non-exclusive clinical trial site management subsidiary, OneR, delivers complex, multi-center clinical trials to affiliated practices. If you would like to apply or learn more about this opportunity, please email your CV to I look forward to speaking with you!

Job Description Job Title: Patient Recruitment Coordinator (bilingual Spanish required) About Company: Who is ERG? ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with an expertise in early and late-stage neuroscience drug development. With 19 wholly owned clinical sites and 5 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 340+ in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, Acute and Chronic Pain, diabetes and other illnesses as well as normal healthy volunteers who participate in trials for the advancement of medicine. With access to over 32 million patients/subjects and 5000 + completed trials, ERG continues to grow its capabilities and expand into indications where there are tremendous unmet medical needs in the United States and globally. Job Description: The Patient Recruitment Coordinator is responsible for interviewing, pre-screening and setting appointment for patients’ clinical study participation. Must have the ability to analyze information provided by the potential participant to determine study participation eligibility. The Patient Recruitment Coordinator will be mentored on these protocols by the Recruitment Manager with input from the Centralized Recruitment Department, Site Director, and Principal Investigators. Must be bilingual Spanish. Responsibilities: Patient Recruitment • Field all initial patient phone screenings and input/regularly update all patient information into the patient database to ensure the most accurate database possible., • Run CTMS reports to assist in identifying potential patients for enrolling trials then contacting them and qualifying their interest in the trial., • Work with the Centralized Recruitment Team on enrolling trials to develop recruitment enrollment sheets for use in screening new patients., • Follow up with monitors and medical monitors as needed to determine if a patient fits the trial eligibility requirements., • Coordinate with Recruitment Manager and effectively schedule new patient screening visits., • Follow up with any patients who are scheduled more than a week out to maintain their interest in the trial and to ensure they understand the trial eligibility requirements., • Following up on trial specific, central advertising campaign patients and scheduling them for a trial if they qualify based on pre-screening., • Become proficient in the functionality of CTMS as it relates to Site’s patient database and gain a full understanding of how new/existing patient information should be captured and updated., • Document and maintain all Company processes for fielding and inputting new patient screenings (phone, web submission, in-person);, • Document and maintain all Company processes for, regularly updating existing patient information in CTMS., • Document and maintain all Company processes for managing the process of generating Salesforce Reports., • Demonstrate knowledge of the sites clinical research studies as well as the diagnoses and medical terminology that is involved in each study, • Responsible for understanding the protocols and exclusions and a comprehensive understanding of each trial being conducted, • Education and experience, • High School Diploma (College Degree preferred), • At least two-years’ experience in sales, medical or clinical research setting (patient recruiting experience strongly preferred), • Requirements, • Excellent communication skills (interpersonal, written, verbal), • Excellent persuasive/selling skills, • Well-developed interpersonal skills and the ability to work well independently as well as with co-workers, peers, supervisors, and external patients, • Must be professional, possess a high degree of urgency and self-motivation, and have a strong work ethic, • Good organizational and interpersonal skills, • Attention to detail., • Friendly, outgoing personality; maintain a positive attitude under pressure, • Excellent Computer Skills to include Word, Excel, PowerPoint, • Experience with a CTMS system preferred, • Medical Skills: Proficiency in medical terminology. Familiarity with pharmaceutical drugs preferred.

Job Description Location: Menlo Park, CA; Miami, FL; Princeton, NJ (onsite) or REMOTE About Summit: Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials: * HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib). * HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. * HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression. Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting. Overview of Role: The Director, Corporate Counsel, is responsible for the drafting, negotiation, and execution of company contracts across multiple departments. This position is within the Legal Department and partners with clinical operations, medical affairs, finance, research & development, IT, human resources, facilities, and other internal clients from other departments to draft and negotiate contracts that protect the company from risk, support company business objectives, and ensure compliance with company guidelines. Role and Responsibilities: • Draft, review, analyze and negotiate a wide range of contracts, with an emphasis on clinical trial agreements and ISTs. In addition to clinical trial agreements and ISTs, draft, review, and negotiate agreements with contract research organizations (CROs), sponsored research agreements, advisory board agreements, collaboration agreements, licensing agreements, consulting and contractor agreements, master services agreements and related statements of work, promotional speaker bureau agreements, vendor and service contracts and related work orders, IT/software agreements, facilities and lease agreements, human resource/employee benefit agreements, and confidentiality or non-disclosure agreements., • Acts as the primary contact between the internal business units and external parties, ensuring that all legal and contractual matters are addressed efficiently and promptly; escalate matters, as necessary, to reduce company risk and help ensure company business objectives are met., • Develop strong working relationships with functional groups and project teams., • Promptly respond to complex inquiries regarding contract obligations and revisions., • Identify risks and issues, suggest alternatives that meet company business objectives while also reducing company risk., • Prepares and timely disseminates information regarding contract status, compliance, modifications, etc., • Reviews, analyzes and tracks in-process and on-going agreements., • Reports the status of contracts to internal clients using established processes and updated processes as necessary., • Provide training to company employees regarding contract review and management processes., • Responsible for effectively interacting with Intellectual Property Counsel to ensure appropriate handling of intellectual property issues in agreements., • Effectively interacts with Regulatory Counsel and Compliance to ensure appropriate handling of regulatory/compliance issues in contract matters., • Effectively interacts with Quality Assurance to ensure appropriate handling of quality matters., • Prepare template agreements, modify existing templates and prepare unique agreements as required., • Ensure clear and prompt communication with company employees, and outside parties regarding status of, or issues in, contracts., • Handle miscellaneous legal tasks or special assignments on an as-needed basis., • Juris Doctorate from an accredited law school, and admitted to a US state bar in good standing., • Minimum of 7+ years of experience with contracting and negotiation at a law firm and/or in-house with a pharmaceutical, medical device, or healthcare company, • Prior clinical trial agreement negotiation and drafting experience (U.S. and ex-U.S.) with a pharmaceutical company, • Precise drafting and strong legal analysis skills, and knowledge of the regulations and statutes and industry guidelines impacting pharmaceutical research, development and commercial contracts, including GDPR and other data privacy laws., • Proficient with Word and have a working knowledge of Excel., • Excellent written and oral communication skills; ability to work effectively and efficiently with all levels of management and personnel., • Able to handle multiple projects in a timely manner, • Strong interpersonal skills including a strong sense of being a team player, • A keen understanding of business and the ability to diagnose legal problems and present positive, creative solutions and alternatives for management, • Strong organizational and planning skills and meticulous attention to detail, • Able to work independently while exercising initiative, flexibility and good judgment, • Works well under pressure to meet specific deadlines Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.

Job Description Location: Menlo Park, CA; Miami, FL; Princeton, NJ onsite or REMOTE About Summit: Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials: * HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib). * HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. * HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression. Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting. Overview of Role: The Clinical Contracts Manager is responsible for the drafting, negotiation, and execution of company contracts across multiple departments. This position is within the Legal Department and partners with clinical operations, medical affairs, finance, research & development, IT, human resources, facilities, and other internal clients from other departments to draft and negotiate contracts that protect the company from risk, support company business objectives, and ensure compliance with company guidelines. Role and Responsibilities: • Draft, review, analyze and negotiate a wide range of contracts, with an emphasis on clinical trial agreements and ISTs. In addition to clinical trial agreements and ISTs, draft, review, and negotiate agreements with contract research organizations (CROs), sponsored research agreements, advisory board agreements, collaboration agreements, licensing agreements, consulting and contractor agreements, master services agreements and related statements of work, promotional speaker bureau agreements, vendor and service contracts and related work orders, IT/software agreements, facilities and lease agreements, human resource/employee benefit agreements, and confidentiality or non-disclosure agreements., • Acts as the primary contact between the internal business units and external parties, ensuring that all contractual matters are addressed efficiently and promptly; escalate matters, as necessary, to reduce company risk and help ensure company business objectives are met., • Develop strong working relationships with functional groups and project teams., • Promptly respond to complex inquiries regarding contract obligations and revisions., • Prepares and timely disseminates information regarding contract status, compliance, modifications, etc., • Reviews, analyzes and tracks in-process and on-going agreements., • Reports the status of contracts to internal clients using established processes and updated processes as necessary., • Escalate legal issues to the Sr. Corporate Counsel, as needed, • Effectively interact with Intellectual Property Counsel and Compliance to ensure appropriate handling of intellectual property and compliance issues in contract matters., • Effectively interacts with Quality Assurance to ensure appropriate handling of quality matters., • Ensure clear and prompt communication with company employees, and outside parties regarding status of, or issues in, contracts., • Handle miscellaneous tasks or special assignments on an as-needed basis., • Bachelor’s degree in relevant legal or business field, • Minimum of 5+ years of experience with contracting and negotiation, • Extensive clinical trial agreement negotiation and drafting experience (U.S. and ex-U.S.) with a pharmaceutical company, • Precise drafting and negotiation skills, and knowledge of the regulations and statutes and industry guidelines impacting pharmaceutical research, development and commercial contracts, including GDPR and other data privacy laws., • Experience with contract lifecycle management (CLM) systems, • Proficient with Word and have a working knowledge of Excel., • Excellent written and oral communication skills; ability to work effectively and efficiently with all levels of management and personnel., • Able to handle multiple projects in a timely manner, • Strong interpersonal skills including a strong sense of being a team player, • Works well under pressure to meet specific deadlines Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.

Job Description Location: Menlo Park, CA, Princeton NJ or Miami FL. onsite 4 days per week About Summit: Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials: • HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced, or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib)., • HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. Overview of Role: The Clinical Trial Manager is a highly autonomous and experienced clinical operations professional responsible for all aspects of Clinical Trial Management for global studies. Responsible for study start up and maintenance through study close out. Coordinates, leads and drives leads Summit cross functional team members, CROs and vendors to successfully deliver clinical studies. Responsible for all performance metrics and quality of deliverables in the clinical trial. Role and Responsibilities: • Oversees study scope, quality, timelines, and budget with the internal Summit functional leads, CRO and vendors to ensure that overall project objectives are met, • Initiates and builds solid professional relationships with key opinion leaders and clinical site staff, • Partners with the CRO to ensure robust patient enrollment strategies are developed and carried out effectively to ensure patient enrollment is completed on time, • Partners with the CRO to ensure robust ongoing data monitoring strategies are developed and carried out effectively to ensure delivery of high-quality data, • Proactive identification and management of study related risks, • Responsible for the development and management of clinical trial documents including (but not limited to) protocols, Case Report Forms (CRFs), consent documents, confidentiality agreements, • Responsible for reviewing and managing study related plans, processes including, • Investigator agreements (CTA), CRFs, CRF guidelines, statistical / pharmacokinetic analysis plans, monitoring plan, data management, safety monitoring, • Responsible for reviewing CRO and vendor contracts/work orders and specifications to enable study objectives to be met, • Reviews and approves essential document packages to enable timely site activations, • Reviews pre-study, study initiation, interim monitoring visit and at study closeout visit report, • Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates, • Directs investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary, • Responsible for oversight on the maintenance of the TMF and completeness at the end of the study, • Perform periodic QC of the TMF, • Oversee the creation and execution of clinical trial activities in accordance with Good Clinical Practices. Ensure compliance of clinical trials with national and international regulatory requirements and co-monitoring the assigned clinical trial following company SOPs, • Ensures the study is “inspection ready” always, • Responsible for oversight and coaching of the functional activities of Clinical Trial Associates allocated to the project, • Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred, • Minimum of 5+ years of clinical project management experience in conducting international clinical trials in sponsor Pharma/Biotech organization, • Prior phase II and III experience required, • A solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process, • Experience with budget forecasting and management, • Experience with clinical studies in oncology, • Ability to travel internationally to visit clinical sites and for study meetings. Amount will vary upon project needs (up to 20%), • Proven proficiency in overseeing large complex studies being managed in house and by a CRO, • Demonstrated ability to lead teams and work in a fast-paced team environment, • Experienced and enjoys building relationships with KOLs and site personnel, • Ability to successfully engage and work collaboratively with overseas clinical operations team members/colleagues, • Demonstrated ability to build and deliver on patient enrollment strategies, • Excellent interpersonal and decision-making skills. Demonstrates innovation, possesses drive, energy, and enthusiasm to deliver the program objectives, • Demonstrated ability to comprehend complex scientific concepts and data, • Proficient in reviewing and assessing clinical data, • Possesses excellent planning, time management & coordination skills, • Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs, • Experience in working in a small organization Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.

Job Description Location: On-Site 4 days per week at our Menlo Park, CA or Princeton, NJ office. About Summit: Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials: • HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced, or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib)., • HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. Overview of Role: Summit is seeking an experienced, detail-oriented Manager of Clinical Data Management with a strong background in oncology clinical trials. This role will lead and oversee clinical data management activities, ensuring the integrity, quality, and timeliness of clinical data across multiple oncology studies. Role and Responsibilities: • Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards., • Provide strategic oversight and direction to CRO clinical data management teams for assigned studies., • Develop and implement data management plans, case report forms (CRFs), edit checks, and data validation plans in alignment with study protocols and regulatory requirements., • Oversee the design, build, and validation of clinical databases using Medidata Rave EDC, ensuring optimal configuration and functionality., • Conduct thorough reviews of clinical data, identifying trends, inconsistencies, and potential issues that may impact data quality or study outcomes., • Collaborate with cross-functional teams including Biostatistics, Clinical Operations, Safety, and Regulatory to ensure alignment of data management strategies with overall clinical development goals., • Provide oversight, and performance management of external data management vendors., • Maintain SOPs, guidelines, and best practices for clinical data management processes., • Represent the Clinical Data Management function in internal and external meetings, providing expert guidance on data-related matters., • Stay current with industry trends, regulatory requirements, and technological advancements in clinical data management, particularly in the oncology field., • Bachelor's degree in Life Sciences, Computer Science, or a related field; advanced degree preferred., • A minimum of 5+ years of clinical data management experience in the biotechnology or pharmaceutical industry., • Experience managing oncology clinical trials data, including a deep understanding of oncology-specific data requirements and challenges., • Expert-level proficiency with Medidata Rave EDC, including system configuration, form design, and edit check programming., • Strong knowledge of clinical research processes, FDA & ICH guidelines, GCP, GCDMP, and CDISC standards., • Demonstrated experience in CRO and vendor oversight., • Excellent project management skills with the ability to manage multiple studies simultaneously., • Strong analytical and problem-solving skills with meticulous attention to detail., • Outstanding communication and interpersonal skills, with the ability to effectively collaborate with diverse stakeholders., • Proficiency in Microsoft Office Suite and familiarity with statistical software (e.g., SAS, R) is a plus., • Preferred Qualifications:, • CCDM® (Certified Clinical Data Manager) certification, • Experience with risk-based monitoring in oncology studies Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.

Job Description About Care Access Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit . How This Role Makes a Difference The Clinical Research Assistant for the Future of Medicine program is an entry-level clinical position designed to fully integrate individuals into the Care Access research process. The Future of Medicine program brings clinical trials directly into communities, making research more accessible and inclusive for diverse populations. As a Clinical Research Assistant for Future of Medicine, you'll bring your skills wherever the research happens whether that is in local clinics, at community events, and occasionally at regional events (with travel up to 25%). This role offers opportunities for growth and advancement within the Care Access Research organization. How You'll Make An Impact • As a Clinical Research Assistant, you'll support every stage of the research process: engaging with participants and collecting biospecimens, to managing data and maintaining regulatory compliance. You'll help bring clinical trials directly into local communities by supporting recruitment, outreach, and event operations. Along the way, you'll gain hands-on experience in clinical research with opportunities to grow your skills and career., • Clinical & Participant Care, • Perform independent venipuncture, including managing difficult draws and re-attempts per protocol., • Collect, label, process, package, and ship biospecimens while maintaining chain of custody and temperature controls., • Obtain informed consent under the direction of the Clinical Research Coordinator (CRC)., • Complete protocol-required visit procedures under CRC direction., • Communicate clearly with participants and on-site teams; escalate issues promptly., • Maintain effective, professional relationships with participants, investigators, and sponsor representatives., • Study Operations & Data Management, • Record and enter data in real time on paper or e-source documents, ensuring accuracy and legibility., • Request and manage medical records for potential and current participants., • Update study trackers, online recruitment systems, and site logs., • Request and issue study participant payments., • Maintain adherence to FDA regulations, ICH guidelines, and institutional SOPs., • Member Education & Community Engagement, • Participate in member education and pre-screening events, which may occur at multiple locations., • Set up and tear down event sites; prepare kits and supplies, ensuring aseptic technique and biohazard safety., • Assist with distribution of outreach and education materials., • Schedule participant visits and provide reminders., • Clinical Site & Administrative Support, • Assist with administrative tasks such as copying, scanning, filing, mailing, and emailing., • Support inventory management and ordering of equipment and supplies., • Contribute to maintaining an organized, compliant site environment., • Other Responsibilities, • Communicate clearly in both verbal and written form., • Perform other duties as assigned in support of study success. The Expertise Required, • Technical & Operational Proficiency, • Comfortable using eSource/mobile apps and standard office tools., • Proficiency in Microsoft Office Suite., • Ability to learn and adapt in a fast-paced, evolving environment., • Strong organizational skills with close attention to detail., • Professional & Interpersonal Skills, • Excellent verbal and written communication skills with a high degree of professionalism across diverse groups., • Friendly, outgoing personality with the ability to maintain a positive attitude under pressure., • Critical thinker and problem solver with strong initiative., • Ability and willingness to work independently with minimal supervision while contributing effectively to team and site goals., • High level of self-motivation, energy, and an optimistic "can do" attitude. Certifications/Licenses, Education, and Experience:, • Clinical Skills & Experience, • 1+ year of recent, hands-on phlebotomy experience in a clinical setting (≥200 venipunctures; ≥25–50 capillary sticks; ≥30–50 in the last 2–3 months)., • Demonstrated competency in specimen processing., • Working knowledge of medical and research terminology, ICH-GCP, HIPAA/PHI handling, and related federal regulations., • Some prior clinical research experience preferred., • Current national phlebotomy certification, such as:, • ASCP Phlebotomy Technician (PBT), • AMT Registered Phlebotomy Technician (RPT), • NHA Certified Phlebotomy Technician (CPT), • NCCT National Certified Phlebotomy Technician (NCPT), • State-specific licensure/certification if required (CA, WA, LA, NV). How We Work Together, • Location: This position is for a full-time, hourly role. The standard schedule is Tuesday through Saturday, averaging 32–42 hours per week. Work is typically split between community events and a local clinical site (for example, a Houston-based team member may spend three days at community events and two days at the local site) Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to:

Job Description POSITION PURPOSE: The Forensic Restoration Specialist works with clients who have been evaluated by court and have been found Incompetent to proceed; assisting clients with achieving a better understanding of the legal system and how it applies to them. POSITION REQUIREMENTS / QUALIFICATIONS: Education/Experience: Bachelor’s Degree in criminal justice, psychology, social work, sociology, or related fields and at least three (3) years of practical experience in community mental health, forensic mental health or criminal justice. Licensure / Certification: Maintain current CPR Certification from the American Heart Association. Must have a valid Florida Driver’s License. Skills / Ability: Knowledge of issues related to criminal justice, community mental health, case management and community resources. Knowledge of personal computer software, i.e. Word, WordPerfect, Excel, Internet Explorer. Ability to communicate effectively orally and in writing. Ability to follow oral and written instructions. Detail-oriented, goal-oriented. Ability to maintain complex records. Ability to establish and maintain effective relationships with co-workers, the judiciary, court administration, and other agencies. Ability to converse in Spanish and/or Creole a plus. POSITION RESPONSIBILITIES (THIS IS NON-EXEMPT POSITION) Maintain close working relationships with the Community Mental Health Centers, Community Case Managers, Public Defenders, the Office of the State Attorney, and the Mental Health Administrator’s Office. Work with clients who have been evaluated by court and have been found Incompetent to Proceed. Assist clients with achieving a better understanding of the legal system and how it applies to them. Reviews the process and criteria used by legal experts used within the United States. The criteria used will be extracted from the Supreme Court decision Dusky vs. U.S., which is intended to protect the client and their rights as a defendant. Must obtain a certification of attendance from the Florida Forensic Examiner Training presented by the Louis de la Parte Florida Mental Health Institute within one (1) year of employment. Assess clients and assist them with appreciation of charges, appreciation of penalties, understanding the legal process, the capacity to testify relevantly, the ability to disclose information to their attorney, and the ability to manifest appropriate courtroom behavior. Facilitates group and individual community-based Competency Restoration Training client under a conditional release order pursuant to FS 916.17. The education of the client will be taught in the format of individual, group sessions, role play, interactive videos of court proceedings with forensic clients, moderated television style quizzes, workbooks, monthly forums, and moc trials and moc hearings. Work in conjunction with the team Psychologist to prepare clients for Competency evaluations. Responsible to maintain data pertaining to competency restoration training including but not limited to the number of individuals restored to competency, number of individuals whose court jurisdiction is terminated and reasons for termination, etc. Meet with community providers to discuss urgent situations pertaining to the client. The information will be shared with the assigned Conditional Release Monitoring Specialist as soon as possible. Required to perform any job duties that will enhance services provided to the Forensic client Required to travel and competency restoration activities off site. Reliable transportation is a requirement of this position. All referrals to the community must be reviewed and discussed with the Forensic Team Leader. This includes the presentation of the referral packet. Complies with required certification for CPR/CPI. Complies with established facility Policies and Procedures. Participates in staff meetings; responsible for obtaining information in not in attendance. Approaches patients/families, and visitors with a respectful, caring manner to convey a sense of concern and warmth. Maintains confidentiality of patient information and records, staff interrelationships, and communication of sensitive information. Communicates and problem solves via the chain of command. Communicates with staff, patients, families, and visitors with courtesy and respect. Delivers care in a non-judgmental and non-discriminatory manner, sensitive to patient diversity. Seeks constructive criticism and has the ability to evaluate suggestions objectively Participates and utilizes opportunities for personal growth and development. Maintains flexibility and adaptability to expect or unexpected changes in work environment. Attends in-services and educational training as necessary. Reports to work as assigned. Completes daily tasks as assigned. Promotes a favorable/positive work climate. Attends in-service and educational training as necessary Participates in BHCC’s Performance Improvement Activities. Participates in committee as directed by the BHCC Vice-President and Clinical Coordinator. Maintains 80% productivity monthly. Reports to work on time and ready to work with minimal absenteeism. Adheres to Confidentiality Policies and Procedures / HIPAA Regulations. Performs other duties as assigned.

Job Description Location: On-site 4 days per week at our Menlo Park, CA, Princeton, NJ or Miami, FL office. About Summit: Ivonescimab, also known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials: * HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib). * HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. * HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression. Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting. Overview of Role: The Senior Director, Clinical Operations (TMF) is a clinical research drug development expert accountable for leading and optimizing the delivery of our next generation, integrated platform for clinical trial operations and document management systems including the people, process, technology that support these functions. The individual leads transformative initiatives that create effective and efficient processes that meet high compliance standards; collaborating across Development (focus on Clinical Operations); serving as a change manager to implement new systems and practices that support the organization as we continue to grow. The Senior Director, Clinical Operations (TMF) is an effective clinical operations team leader accountable for talent acquisition, development, management, and evaluation of team members in his/her/their group. This includes responsibility for the ‘What’ (delivery to performance goals) and the ‘How’ (deliver consistent with Summit Therapeutics core values). The individual is also a member of the Clinical Operations extended leadership team and as such supports and influences the direction of the Clinical Operations extended team. The individual collaborates with team members to reinforce and operationalize strategic direction and solutions that support the ability to deliver on commitments to the organization and to patients. Role and Responsibilities: • Develop, implement, and oversee the CTMS and TMF systems and related processes, • Lead the oversite of TMF and CTMS vendors, contractors, and cross-functional teams, • provide leadership and development to existing TMF employees and lead by example by demonstrating our core values, • Define, eexecute, and communicate the strategic vision for TMF and CTMS to maximize end user focus and engagement, • Partner with key internal and external stakeholders to remediate risks and manage emerging issues., • Develop proactive approaches to process improvements and enhancements of TMF and CTMS capabilities and standards, • Provide business level leadership, foster best practices, and mentor and consult on TMF and CTMS across the Development and Operations organizations, • Lead a team of TMF and CTMs colleagues and ensure their continuous development, • Develop and maintain effective working relationships with stakeholder functions to achieve Clinical Operations goals, • Keep current on changes in industry and regulatory standards for GCP requirements and advises on business impact for TMF and CTMS, • Provide strategic leadership, insight, and guidance as an active member of the Clinical Operations Extended Leadership Team (XLT), • Ensure inspection ready TMF and CTMS and provide expert support for audits and inspections, • Instill a culture of continuous improvement; acts as a change champion and effectively leads change, • Other key assignments including ad hoc and stretch assignments in support of Clinical Operations and clinical trial execution, • Travel on assignment (~25%), • All other duties as assigned Experience, Education and Specialized Knowledge and Skills: • Bachelor's degree (e.g. BA, BS or equivalent) required; preferably in life science; a clinical or advanced degree in a science, health related, or industry related discipline is preferred, • Minimum of 12+ years of strong experience with a pharmaceutical company and/or CRO with increasing levels of responsibility in Clinical Operations in a global environment (including directing platform support teams and key clinical systems such as TMF, CTMS) preferred, • A minimum of 5+ years of experience in people management/leadership required, • Proven line and functional manager experience, able to effectively lead teams including regional (multi-country) and remote-based staff, • Experience in Phase III execution of clinical trials; Oncology trials preferred, • Previous regulatory inspection experience preferred, • Strong comprehensive and current regulatory knowledge, including ICH Good Clinical Practice, regulations and guidelines Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.

Job Description Do you want to be part of an organization that is making a difference in the lives of millions of people worldwide? If so, we want to hear from you! As an Assistant Research Coordinator, you will assist the research coordinator (CRC/CCRC) in conducting clinical trials. The research associate is responsible for collecting, processing, storing and handling clinical specimens (as needed), scheduling study subjects for study visits, and collecting, recording, and filing clinical research data. QPS’ Story: Since its inception, QPS has been assisting pharmaceutical, biotechnology and medical device companies with their drug development efforts by providing a full range of services, including Early Phase Clinical and Phase II – IV Clinical Research services. The QPS location in Miami, Florida is a multi-specialty research center employing clinical research professionals, including board-certified physicians, in a 32,000 square foot space. To meet the needs of our clients, we strive to employ talented, caring and committed individuals who will work collaboratively towards achieving our mission of improving human health and the quality of life. Team members enjoy challenging and rewarding work and are encouraged achieve their best. Underpinning the operation is a culture that values diversity, innovation, accountability, teamwork and a friendly atmosphere where performance is recognized and rewarded. We provide unique company benefits, training, and advancement opportunities. Most importantly, we value each of our team members as employees and as individuals. If this sounds like your ideal work environment, then we would love to speak with you, so apply today! Please visit our website () for more information and to see all current openings. The Job • Establish good rapport with potential study subjects, • Clinical data collection such as vital signs, ECG recording, subject height and weight, etc., • Laboratory specimen collection and processing (as needed), • Timely recordkeeping of completed study visits & procedures in organization’s Clinical Trial Management System, • Review and retrieve medical records Requirements • High School diploma or equivalent, • Minimum one (1) year experience as a Medical Assistant OR have background experience of at least one (1) year in an ancillary or allied health specialty, • Excellent communication skills., • Exceptional telephone skills., • A bilingual person in English and Spanish is preferred., • Must be flexible with schedule (3pm-11pm shift, & some weekends) Why You Should Apply • Great learning opportunities, especially for those new to the field. Our seasoned professionals are here to support and work with you to explore your learning potential and career goals., • Bonuses and merit increases are a part of the QPS total rewards approach and are linked to individual, team and company performance., • Solid Benefits package, including Company-matched 401(k), and Company-sponsored Group Life/AD&D and Short and Long-term Disability Insurance QPS is an Equal Employment Opportunity/Affirmative Action Employer. In accordance with federal, state, and local laws, we recruit, hire, promote and evaluate all personnel without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, citizenship status, physical disability, protected veteran status, or any other characteristic protected by law. Job applicants and present employees are evaluated solely on ability, experience, and the requirements of the job. In addition, QPS, LLC is a federal contractor and desires priority referrals of protected veterans.

Job Description Location: On-Site 4 days per week at our Menlo Park, CA, Princeton, NJ or Miami FL locations About Summit: Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials: • HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced, or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib)., • HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. Overview of Role: We are seeking an experienced and highly motivated Manager to join our team. This role is crucial in managing site agreements to support our programs. The ideal candidate will have extensive experience in site contract and budget negotiation, as well as managing relationships with clinical research sites. You will support clinical benchmarking and site budget development, escalation, and payment activities for the Clinical Operations department. You will partner with functional leads of departments to establish strategic approaches to fair market value negotiations and enable site activations. Role and Responsibilities: • Under minimal guidance, develop pricing strategies for site budgets to enable contract execution and site activation, • Collaborate with legal, finance, CRO and clinical teams to ensure site agreements comply with regulatory and company standards, • Negotiate and finalize site agreements, including budgets, contracts, and other necessary documentation. Knowledge of CTA legal risks and possible fallback language required, • Rigorous analysis of budgets with the goal of securing the best price, • Confidently present the budget to the Chief Accounting Officer for approval, ensuring full knowledge of all details, • Partner with Clinical Finance team to provide study-wide site payment estimates and forecasts, • Work with legal counsel to ensure appropriate indemnification, liability, and confidentiality provisions are included in contracts, • Provide regular updates to study management on progress and key performance indicators related to trial agreements, • Work with Finance and Clinical Leadership as needed to address budget, invoice, payment, and PO concerns, • Collaborate with external functional service providers (FSP) on site budget templates, study-level work orders and POs, and site payment processes, • Build and maintain strong relationships with CROs, FSP providers, and clinical sites, • Monitor FSP providers and ensure adherence to project timelines, quality standards, and contractual obligations, • Ensure timely and cost-effective solutions that meet project timelines and budgets, • Address and resolve any issues or disputes related to site agreements, • Collaborate with internal stakeholders, such as Legal, Clinical Operations and Clinical Development, • Develop and implement innovative ideas and solutions to increase the efficiency of the department, • Bachelor’s degree in Life Sciences, Business Administration or related field required, • A minimum of 4+ years’ experience with clinical trial site agreements in biotech or pharmaceutical setting, • Experience in oncology is highly desirable, • Strong global negotiation and contract management skills, • Experience in clinical operations and/or study start up, • Strong financial acumen and ability to understand and create budgets, • Experience working with site budgets on a global scale, and potential internal escalation pathway, • Strong knowledge of using grant plan or similar benchmarking tool, • Expertise in large, multi-site, clinical trials with multiple vendor types is preferred, • Direct negotiating with sites and vendors is a must, • Good understanding of the clinical process is important, • Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable, • Strong computer and database skills, • Attention to detail, accuracy, and confidentiality, • Clear and concise oral and written communication skills, • Excellent communication, interpersonal and organizational skills, • Critical thinking, problem solving, ability to work independently, • Must be able to effectively multi-task and manage time-sensitive and highly confidential documents, • Prioritize conflicting demands, • Work in a fast-paced, demanding, and collaborative environment Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.

Job Description Location: On-Site 4 days per week at our Menlo Park, CA, Princeton, NJ or Miami FL locations About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence. Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including: Non-small Cell Lung Cancer (NSCLC) * HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. * HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. * HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. Colorectal Cancer (CRC) * HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview of Role: The Manager, Clinical QA will collaborate closely with Regulatory Affairs, QA, R&D and other cross functional teams within the Company to provide GCP/GLP/GPV and compliance-related advice to internal clinical study teams. This will be accomplished through ensuring tactical support is provided to assignments and wherever necessary, taking the lead in ensuring project related procedural documents, comply to relevant GxP’s and regulatory requirements and guidelines. Role and Responsibilities: * Partnering and collaborating with key stakeholders (R&D teams) to ensure that appropriate Quality support is provided to Summit Clinical and pre-clinical programs * Ensuring end-to-end quality management through proactive compliance based on Clinical Development Plan (CDP) * Liaising with the Global Audits and Compliance function to provide lessons learned from audits and inspections to program teams and support implementation of corrective actions * Supporting CRO-relevant meetings, when necessary, to provide quality overview/ training to relevant stakeholders * Providing support during the development and execution of Corrective and Preventive Actions (CAPAs). Coordinating and reviewing CAPAs to ensure adequate CAPAs are defined, implemented, and closed. * Support formal investigations of issues as they arise, ensuring timely escalation to line management if critical incidents are not resolved in due course * Identifying areas of continuous process improvement and engaging QA and key stakeholders as necessary * QA support in interactions with internal and external contacts and Health Authorities (HA), as appropriate. In collaboration with the Global QA team, ensure inspection management by assisting in preparing program teams for FDA, EU, and key HA pre-approval and sponsor-monitor inspections; provide inspection management support and follow-up post inspections. * Support in providing interpretation of regulations and company process standards, guidelines, policies, and procedures to personnel for assigned programs or for continuous improvement projects * Supporting or leading development and driving the implementation of study/program-specific quality plans to ensure proactive management of quality * Supporting rectifying any necessary vendor-relevant issues identified for the assigned program * Ensuring that protocols for assigned programs can be operationalized and address potential risks with key stakeholders * Perform internal audits as applicable * All other duties as assigned Experience, Education and Specialized Knowledge and Skills: * Bachelor's Degree in Life Sciences, Pharmacy, or Nursing required * Master's Degree or other advanced degree preferred * Minimum of 5+ or more years Quality Assurance experience and or Clinical Operations involvement in regulated activities or equivalent experience required * Broad understanding of global expectations of Health Authorities in the management of clinical trials preferred * Thorough understanding of international GCP/GLP regulations including FDA/EU GCP, ICH, pharmacovigilance, new drug regulations, other key HA guidance’s, and current industry practice preferred • Ability to travel up to 20% Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable * Strong computer and database skills * Attention to detail, accuracy and confidentiality * Clear and concise oral and written communication skills * Excellent organizational skills * Critical thinking, problem solving, ability to work independently * Must be able to effectively multi-task and manage time-sensitive and highly confidential documents * Communicate effectively and articulate complex ideas in an easily understandable way * Prioritize conflicting demands * Work in a fast-paced, demanding and collaborative environment The pay range for this role is $139,000-$163,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.

Job Description HSA Florida Physician Group - Practice Manager Summary This position is responsible for all operational aspects of the employed community physicians' office, including but not limited to: staffing, patient relations, liaison with the central billing office, office planning, computer systems and protocol, establishing standards for office operations and procedures, equipment and supply ordering and accounts payable. Responsibilities: • Directly supervises all non-physician staff within the Practice., • Works in concert with Florida Physician Group HR staff to perform the following functions:, • Interviewing and hiring, • Staff training, • Performance evaluations and, • Corrective actions and performance improvement plans., • Manages the re-employment of staff to provide coverage and/or arranges for emergency float coverage of office management, medical assistants, RN's and secretaries as required. Covers nonclinical positions if coverage cannot be arranged., • Assists in preparing and managing the operating budget for the practice. Investigates discrepancies and significant changes in monthly income and expenses. Reports discrepancies to the Practice Administrator/Director of Practice Operations as required. Ensures cost containment guidelines are met for the individual practice., • Provides information and assistance to patients to ensure effective patient relations. Investigates and proactively resolves patient complaints and concerns. Facilitates staff training in new customer service techniques and/or processes., • Liaisons with the Central Billing office to maximize revenue associated with the patient billing process for the Practice and ensure accurate data collections. Researches specific ICD-9 and CPT codes applicable to the Practice and in conjunction with Florida Physician Group practice., • Responsible for coordinating training for physicians and staff in Athena Billing and Steward Medical Group policies and procedures to capture accurate billable information in a timely fashion. Manages staff regarding the utilization of the Athena system to ensure efficient and accurate billing of encounters., • Manages the day-to-day facilities management for the Practice including any repairs or remodeling, service contracts for equipment and the inventory of all capital equipment. Makes recommendations to the Practice Administrator and the Director of Practice Operations regarding office restructuring and expansion. Assists with processing the necessary documentation and managerial support., • Authorizes the procurement of special order medical/surgical supplies and capital equipment., • Assesses needs in collaboration with the clinical staff for the annual capital and expense report, coordinates trials, evaluates and negotiates with vendors in conjunction with the Purchasing Department to procure capital equipment, processes purchase orders, coordinates installation and in-servicing., • Ensures proper invoicing and tracking of receivables and payments to vendors., • Management of the process and office workflow using the electronic healthrecord., • Trains staff, (physicians, nurses, administrative and support staff), on existing programs, quality measures, and Meaningful Use measures as well as any new programs or upgrades in a timely fashion. Presents information at monthly Networking Meetings as required and disseminates information from these meetings to physicians and staff., • Maintains an optimal physical environment for the office and reports any unsafe conditions, inoperative equipment or other adverse conditions to the Practice Administrator and the appropriate department., • Ensures compliance with all Florida Physician Group policies and procedures. Participates in development and evaluation of departmental policies and procedures. Prepares staff to respond effectively to both internal and external disasters and comply with all departmental policies and procedures., • Attends seminars and training sessions specific to the Athena system, CPT coding, capitation, managed care, and physician practice management., • Uses discretion at all times to ensure patient confidentiality. Conforms to the confidentiality policy of Florida Physician Group. Qualifications/Experience • Minimum Education: Bachelor's degree or equivalent., • Minimum Experience: Two to five years of practice management experience in a health care setting., • Supervisory experience, billing and financial management experience required., • Must be proficient in Microsoft Office, Athena and eCW experience preferred., • Ability to speak, read and comprehend the English language fluently required., • Strong interpersonal communication, managerial and organizational skills required. In-depth knowledge medical practice operations and supervision., • Experience with an electronic health record within the medical office preferred., • Patient relations, staffing, billing systems, budget and financial reporting and patient flow and scheduling required., • Knowledge of insurance coverage systems, including but not limited to co-payments, referrals, HMO, PPO and capitated products required., • Knowledge of professional fee for service billing required., • Ability to analyze and solve operational issues independently and creatively required. Strong orientation to patient care in accordance with the values of the Florida Physician Group and HAS., • Must have the ability to analyze, think creatively and to weigh alternatives. Good perception of people and excellent conflict resolution skill required., • Five (5) years experience required, • Bilingual English/Spanish preferred, • Training in quality improvement, ACO, performance improvement, employee relations and staff recruitment strongly preferred. Must be able to pass Background and Drug Test screenings.

Job Description Location: On-site 4 days per week at our Menlo Park, CA, Princeton, NJ or Miami, FL locations About Summit Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational? bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials: * HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib). * HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. * HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression. Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting. Overview of Role: We are seeking a detail-oriented and motivated Site Contracts Associate to join Summit’s Study Start Up group. This role is critical in supporting clinical trial site payment operations using Summit’s preferred vendor payments platform. The ideal candidate will have experience in site payment processing, financial compliance, and cross-functional collaboration to ensure timely, accurate, and compliant payments to clinical research sites. Role and Responsibilities: * Serve as the primary liaison for internal teams (Clinical Operations, Finance), site payment vendors, and external site representatives for site payment set up and payment queries. * Serve as the primary point of contact for configuration and maintenance of complex site budgets in vendor platform for new and ongoing studies. * Review and understand site agreements to resolve vendor platform budget set up issues with minimal oversight. * Review executed site contracts to confirm correct configuration of payment schedules and fees. * Attend internal study meetings and utilize internal trackers to ensure appropriate prioritization of site budget set up. * Ensure adherence to sponsor and regulatory requirements for financial transparency and Sunshine reporting. * Support budgeting and benchmark database * Collaborate with Legal, Finance, CRO, and clinical teams to ensure payment processes comply with regulatory and company standards. * Support vendor management activities, including monitoring deliverables and service-level agreements. * Develop and implement innovative ideas and solutions to increase the efficiency of the department. * All other duties as assigned. Experience, Education and Specialized Knowledge and Skills: * Bachelor’s degree in Finance, Accounting, Business Administration, or related field required. * Minimum of 2+ years’ experience in clinical research finance, site payments, or contracts management. * Experience with vendor payment platforms preferred. * Experience working with site payments on a global scale is desirable. * Knowledge of clinical trial budgeting and financial lifecycle management. * Experience with vendor oversight and cross-functional collaboration. * Strong analytical skills with proficiency in Microsoft Excel and financial reporting tools. * Excellent communication and stakeholder management abilities. * Critical thinking, problem solving, and ability to work independently. * Must be able to effectively multi-task and manage time-sensitive and highly confidential documents. * Ability to work in a fast-paced, demanding, and collaborative environment. * Knowledge of GCP guidelines and relevant regulatory requirements. The pay range for this role is $42 - $50/hr. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.

Job Description Location: Menlo Park, CA / Miami, FL / Princeton, NJ ONSITE About Summit: Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials: * HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib). * HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. * HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression. Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting. Overview of Role: We are seeking a physician to serve as a Senior Medical Director to oversee global Phase 3 clinical trials a BLA (Biologic Licensing Application) filings. The incumbent will be primarily responsible for developing and executing an integrated clinical trial programs including protocol design and medical oversight of new or ongoing studies.? They will be responsible for obtaining scientific advisory input, work with biostatisticians for phase 3 design and analyses, support regulatory interactions for product advancement, and work closely with clinical operations to provide advice and decision making regarding medical input to achieve operational excellence.? The candidate must have demonstrated effective collaborative skills to work across various phases of clinical development and serve as a key medical expert for multiple cross functional teams.? This position will provide medical insight across a myriad of functions from discovery to manufacturing are expected.? Additionally, the Medical Director will play a pivotal role in leading investigator engagements including travel to support face-to-face interaction and protocol training.? Prior experience in a mid-sized, fast-growing pharmaceutical environment is preferred, as this role will be working on product development in an extremely fast-paced and intense environment.???The Medical Director will serve as a leader on one multiple potentially pivotal programs.? Role and Responsibilities: * Significant Oncology Experience the role will require expertise in the treatment and management of oncology disease such that knowledge can be applied to the strategy and clinical development of Summit medicines to benefit patients * Work cross functionally with Medical Affairs, Regulatory, Commercial and other functions to develop the overall product strategy in multiple indications * Work cross functionally with Clinical Operations, Biometrics, Pharmacovigilance, and other functions to successfully complete clinical development programs leading to BLA approvals * Lead teams to execute on clinical development goals (clinical trial execution, clinical development strategy, medical affairs planning) * Manage direct reports or cross functional team members as needed based on team needs * Contribute to the communication strategy of Summit products via publications, manuscripts, abstracts, posters and scientific presentations * Making vital contributions on pivotal programs in clinical development program? * Directing human clinical trials, phases 1-3, for lead candidate in development, helping to ensure all clinical development milestones are met including enrollment goals * Participating in medical review of adverse event reports and monitoring of incoming safety data in conjunction with product safety/pharmacovigilance, including evaluating and escalating safety signals? * Coordinate and develop information for reports submitted to FDA, EMA, PMDA, and government, regulatory, or partner agencies?? * Presentations to various external stakeholders - regulators, governing and harmonization bodies, principle investigators, scientific conference attendees, advisors and opinion leaders? * Knowledge of clinical trial conduct to support operational needs for planning and executing clinical trials, including adherence to protocols, safety reviews, assay development, training, and clinical document review? * Planning, reviewing and editing Clinical Study Reports? * Planning, reviewing and editing publications from the program * Providing input on the design of clinical studies supporting clinical strategy? * All other duties as assigned Experience, Education and Specialized Knowledge and Skills: * Board certified or eligible MD with hematology/oncology product development and experience across stages of clinical development? * Minimum of 5+ years’ experience in pharmaceutical, biologics, or biotech R&D environment, or in a research environment involving the collection and analysis of human data in the area of hematology/oncology * Working knowledge of clinical development pathways for hematology/oncology therapeutics in the US and EMA? * Self-starter who will move forward with key initiatives without being prompted, able to perform a myriad of tasks needed to support the clinical development program, possesses a highly entrepreneurial and growth mindset, works collaboratively with cross-functional teams, loves a good mission The pay range for this role is $283,000-$353,500 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.

Job Description About Company: Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I–IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally. Why join us? We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge. Job Description: We are seeking a highly organized and detail-oriented Data Entry Coordinator to join our team. As a Data Entry Coordinator, you will be responsible for the overall coordination, organization, and efficient implementation of clinical data. Complete all study related data entry procedures under the direction of the Site Director. Maintain accurate, confidential files and documentation of study participants. In executing these position responsibilities, the Clinical Data Entry Coordinator is guided by Good Clinical Practices (GCP), International Conference on Harmonization (ICH) guidelines, and company standard operating procedures and policies. Responsibilities: • Performing data entry tasks with a high degree of accuracy and efficiency, • Complete any training as required by sponsor for access and approval to complete data entry., • Enter data as appropriate for protocol into paper or electronic case report forms., • Track to ensure that data entry is complete for subjects including completed study visits and related forms., • With CRC and/or manager oversight assist Sponsor or CRO data manager with resolution of queries to ensure clinical data quality., • High school diploma or equivalent, • Proven experience in data entry or a related field, • Proficiency in word processing and database applications, • Excellent attention to detail and accuracy, • High School Diploma or equivalent, • Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) guidelines., • Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner., • Experience working in a clinical or research environment

Job Description Job Title: Recruitment Manager About Company: Who is ERG? ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with an expertise in early and late-stage neuroscience drug development. With 19 wholly owned clinical sites and 5 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 340+ in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, Acute and Chronic Pain, diabetes and other illnesses as well as normal healthy volunteers who participate in trials for the advancement of medicine. With access to over 32 million patients/subjects and 5000 + completed trials, ERG continues to grow its capabilities and expand into indications where there are tremendous unmet medical needs in the United States and globally. Job Description: The Recruitment Manager assists Centralized Recruitment and manages assigned tasks related to the coordination, planning, and implementation of Patient Recruitment and Retention support operational plans at the Site Level. Communicates with recruitment coordinators to implement and monitor impact of the recruitment/retention plans and create and provide project reporting. Collaborates with internal teams and external providers to coordinate aspects of tactics associated with the recruitment/retention strategy. May assist Centralized Recruitment to represent Site at site/sponsor-facing meetings, train recruitment coordinators and site staff, and conduct recruitment support outreach as required. Responsibilities: Project Management • Assist Site Director and Centralized Recruitment in completion of the scope of work, objectives, quality of deliverables, and other activities of projects as deemed necessary., • Assist in coordination of project activities for team members regarding their project-oriented tasks to ensure that project milestones are met., • Assist in tracking resources to ensure adequate coverage to meet project deliverables and milestones., • Provide technical support as necessary on project specific and interdepartmental training efforts., • Communicate with sites regarding Recruitment and Retention activities, including but not limited to, making follow-up calls regarding patient referrals, tracking logs, receipt of Recruitment and Retention materials, etc., • Become proficient in the functionality of CTMS as it relates to Site’s patient database and gain a full understanding of how new/existing patient information should be captured and updated., • Document and maintain all Company processes for fielding and inputting new patient screenings (phone, web submission, in-person)., • Document and maintain all Company processes for, regularly updating existing patient information in CTMS., • Manage and maintain data tracking entries into designated tracking systems and tools in accordance with project requirements., • Assist and maintain data tracking entries into designated tracking systems and tools in accordance with project requirements., • Assist Centralized Recruitment with periodic report generation and review., • Manage site recruitment team consisting of recruiters and outreach employees., • Ensure recruitment staff are adequately trained and adhere to Standard Operating Procedures and working guidelines while performing duties on assigned studies., • Education and experience, • Bachelor's degree and 5 years of experience in sales, marketing, communications, or outreach activities., • Demonstrate knowledge of the sites clinical research studies as well as the diagnoses and medical terminology that is involved in each study., • Responsible for understanding the protocols and exclusions and a comprehensive understanding of each trial being conducted., • Study, learn, and comply with ERG/Site standard operation procedures, other policies, practices, and regulations where applicable., • Prior experience in clinical research, patient recruitment experience preferred., • Establish clear direction and lays out work in a well-planned and organized manner., • Deal with performance or problem direct reports in a timely manner., • Requirements, • Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines., • Knowledgeable in medical terminology, • Excellent time-management skills, • Excellent communication skills (interpersonal, written, verbal), • Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager), • Scheduled on-call availability of varying degrees based on demands of specific studies, staff availability, and coordination of schedules.

Job Description Job Title: Psychiatric Medical Director / Principal Investigator Location: West Palm Beach (Boynton Beach), Florida Position Type: Full-Time, Inpatient Overview: We are seeking an experienced Psychiatric Medical Director/Principal Investigator (PI) to lead our inpatient psychiatric program and oversee clinical trials at our West Palm Beach (Boynton Beach) facility. This full-time leadership position is available to start ASAP and requires a physician with demonstrated expertise in psychiatry, inpatient care, and research. Responsibilities: • Provide medical leadership and oversight for the inpatient psychiatric unit, ensuring delivery of high-quality, evidence-based patient care., • Serve as Principal Investigator for clinical trials, maintaining compliance with all federal, state, and institutional research regulations., • Supervise and mentor psychiatric staff, including physicians, nurse practitioners, and clinical teams., • Collaborate with clinical research coordinators, sponsors, and CROs to ensure integrity, safety, and effectiveness of clinical trial protocols., • Conduct patient evaluations, admissions, treatment planning, and ongoing management in the inpatient setting., • Review and approve study-related documentation, adverse event reporting, and regulatory submissions., • Foster a collaborative environment between clinical care and research initiatives., • Develop and implement policies, procedures, and quality initiatives to optimize patient outcomes., • MD or DO degree with Board Certification/Eligibility in Psychiatry., • Active or eligible Florida medical license., • Prior experience as a Medical Director and/or Principal Investigator in clinical trials required., • Strong background in inpatient psychiatry, including acute care and crisis stabilization., • Proven leadership skills with the ability to manage multidisciplinary teams., • Knowledge of Good Clinical Practice (GCP), FDA, and IRB guidelines., • Competitive base salary with performance-based incentives., • Comprehensive health, dental, and vision benefits., • Malpractice coverage provided., • CME allowance and professional development support., • Relocation assistance available., • Full-time, primarily inpatient with clinical trial oversight., • Monday – Friday, with some on-call responsibilities as needed

Job Description About Company: Who is ERG? ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with an expertise in early and late-stage neuroscience drug development. With 19 wholly owned clinical sites and 5 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 340+ in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, Acute and Chronic Pain, diabetes and other illnesses as well as normal healthy volunteers who participate in trials for the advancement of medicine. With access to over 32 million patients/subjects and 5000 + completed trials, ERG continues to grow its capabilities and expand into indications where there are tremendous unmet medical needs in the United States and globally. Job Description: The Nurse Practitioner (NP)/Physician Assistant (PA) is responsible for providing primary care to patients within the facility, as well as keeping records of patients’ health, creating patient care plans, and administrating diagnostic tests. This role will require working closely with the Clinical Research Coordinators, assisting in tasks that relate to the conduct of clinical trials. This position is essential to providing support to our other clinicians within the unit and to our patients overall positive health. Additionally, this position will take on a Clinical Manager role as well, mentoring staff at the research site and assisting in overseeing employees’ performance, evaluations, corrective action plans, and the management of staff schedules. The Clinical Manager is essential in the day-to-day management to ensure that the site is running smoothly and effectively. The typical responsibilities include developing and implementing policies and directives, handling communications, managing staff recruitment, providing quality training to the staff, and supervising overall daily activities at the site. Not only is this position crucial to employees but also will be evaluating and implementing study protocols. Responsibilities: • Monitor and operate medical equipment., • Perform physical exams and patient observations., • Administer medications and treatments and monitor patients., • Assist in documentation management., • Protocol related clinical assessments of research subjects., • On call coverage if applicable, • Detect changes in a patient’s health and change treatment plans, as necessary., • Providing profitable management of the clinical research business, consistent with company policies, principles, strategies, and objectives, • Accountable for the overall coordination, organization, and efficient implementation of clinical trials management, operations, and regulatory compliance, • Attend meeting and communicate with staff., • In executing these position responsibilities, the Nurse Practitioner/Clinical Manager is guided by Good Clinical Practices (GCP), International Conference on Harmonization (ICH) guidelines, Health Insurance Portability and Accountability Act (HIPAA) and company standard operating procedures and policies., • Education and experience, • For an NP-Master of Science in Nursing (MSN) or Doctor of Nursing Practice (DNP) from an accredited program. Current valid RN license. Board Certification., • For a PA-Completion of an accredited Physician Assistant program. State specific PA license. Board Certification., • For MD/DO, State specific license, board certified., • 5+ years in a leadership role with on-site management responsibilities, • Superior knowledge of multiple operational functions and principles, including quality assurance finance, and employee management., • Proven ability to plan and manage operational processes for maximum efficiency and productivity., • Ability to streamline and implement new structures and roles that create speed, efficiency, and support rapidly shifting business demands., • Strong working knowledge of industry regulations and legislative guidelines, • Requirements, • Masterful organizational, communication, and leadership skills, demonstrated by previous professional success leading a multifunctional team., • Experience business plan development and budgeting, • Proven ability to develop innovative solutions for increased productivity., • Superior negotiation skills in both internal and external settings, • Working knowledge of Clinical Trials related to CNS studies.

Job Description Clinical Research Site seeking full time clinical research coordinator with experience. Must be Bilingual. Responsibilities: • Must be able to manage an coordinate accordingly, • Must provide clinical research support to investigators to prepare for and execute assigned research studies including, reviewing protocols, case report forms, study specific documents and electronic data capture systems use to record research data, • Recruit and screen subjects for clinical trials and maintain all logs, • Orient research subjects to the study, • Design and maintain source documentation based on protocol requirements, • Schedule and Execute study visits and perform all study procedures, • Collect, Record and maintain research subject study data according to protocol and SOPS, • Handle lab testing and analysis including preparation of specimen collection tubes and lab logistic, • Monitor subject safety and report adverse reaction to appropriate medical personnel, • Trouble shoot study related question and concerns and resolve all queries in a timely manner, • Must be Bilingual ( English/Spanish), • 2+ years of Experience, • Strong computer skills and knowledgable with medical terminology, • Knowledge of Office 365, • Excellent organization skills, • Excellent written and oral communication skills, • Excellent Time management, • ICH and GCP certifiedCompany DescriptionWE ARE A GROWING COMPANY WITH VARIOUS DOCTORS SERVING AS PI IN DIFFERENT AREAS OF PRACTICE. WE SPECIALIZE IN CLINICAL TRIALS WE DO NOT OFFER REGULAR MEDICAL SERVICES.WE ARE A GROWING COMPANY WITH VARIOUS DOCTORS SERVING AS PI IN DIFFERENT AREAS OF PRACTICE. WE SPECIALIZE IN CLINICAL TRIALS WE DO NOT OFFER REGULAR MEDICAL SERVICES.

Job DescriptionDescription: Job purpose Under supervision of the Vice President of R&D, the Product Development Engineer II is responsible for researching and developing new production processes or products from bank human tissue, making modifications to existing manufacturing systems and processes, and to improve the overall efficiency of the R&D department. Duties and responsibilities • Evaluate the feasibility of selected concepts to meet the clinical and customer needs., • Generate design history documents in compliance with regulating bodies., • Expert ability to design research approaches and design of experiments for assigned projects., • Identify needs and goals for a new products and processes, including defining specifications and tolerances captured in user and engineering requirements., • Coordinating with marketing and material suppliers to evaluate market needs and identify existing competition., • Coordinating with finance to develop timelines and project plans and cost estimates of new products/processes developed, and to appraise management of performance against plan., • Plan and organize engineering runs, including writing of validation protocols and testing instructions, and performing trials and analyzing data., • Works specifically to develop new tissue products or processes and ensure proper technology transfer occurs, including identification of material and service suppliers, writing the necessary work instructions and SOPs, ensuring the final product/process meets regulatory compliance, and product safety., • Can provide mentorship to junior scientists and engineers, including students and interns, to promote skills and growth., • Other duties as assigned. Requirements: Qualifications • BS, Advanced degree (Master’s, PhD) a plus, in engineering. Relevant experience in product development preferred., • CTBS certified (or certified within two years of employment), • Thorough understanding of design control processes and requirements., • Strong knowledge of AATB and FDA regulations as they pertain to human tissue banks., • Excellent analytical, problem solving, and investigative skills., • Demonstrates excellent communication (both oral and written) skills. Working conditions Job requires working in office, laboratory, and manufacturing environments. There will be evening and weekend work. Physical requirements Job is one where the incumbent is required to stand for extended periods of time, lift heavy objects, and do repetitive tasks with few breaks while executing research plans. Direct reports N/A

Job Description Job Title: Manager/Director of Clinical Operations, Phase I Location: CPMI-Miami, FL This is a newly created role at an amazing, top clinical research site located in Miami, FL About Company: Who is ERG? ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with an expertise in early and late-stage neuroscience drug development. With 19 wholly owned clinical sites and 5 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 340+ in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, Acute and Chronic Pain, diabetes and other illnesses as well as normal healthy volunteers who participate in trials for the advancement of medicine. With access to over 32 million patients/subjects and 5000 + completed trials, ERG continues to grow its capabilities and expand into indications where there are tremendous unmet medical needs in the United States and globally. About the Role: We are seeking a highly qualified Manager/Director of Clinical Operations, Phase I, to oversee clinical trials, ensuring protocol adherence, and managing both staff and operational aspects of studies. This role demands strict compliance with GCP, ICH guidelines, and company SOPs. Core duties include staff management, protocol review, quality assurance, and overall study supervision. Responsibilities: • Lead and mentor the clinical operations team to promote a collaborative and efficient environment., • Ensure protocol compliance and maintain high-quality standards across studies., • Collaborate closely with Principal Investigators and Site Directors to assign studies and develop enrollment strategies., • Oversee human resources functions, including staff evaluations, recruitment, and training., • Monitor adherence to protocols, reporting any deviations to sponsors and regulatory bodies., • Coordinate with Site Director and Principal Investigator to assign primary clinical research coordinators., • Review study components with Principal Investigators and Site Directors, identifying areas requiring clarification before study initiation., • Conduct study closeout procedures., • Perform additional duties as needed to adapt to the evolving needs of CPMI., • Bachelor's degree in a scientific or healthcare-related field, • 7-10 years of experience in clinical operations, including 5+ years in a senior leadership role., • Strong understanding of FDA, ICH, and GCP regulations and guidelines, • Strong communication, organizational, and leadership skills., • Ability to travel as needed and proficiency in Microsoft Word, Excel, and clinical management software., • In-depth knowledge of clinical trial operations, including study start-up, site selection, patient recruitment, monitoring, data management, and study close-out, • Phase I or early phase experience Our comprehensive benefits package includes: • Health insurance, • Dental & Vision Insurance, • Matching 401k Retirement Plan, • Paid Time Off (PTO)

Job Description About Company: Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I–IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally. Why join us? We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge. Job Description: The Office Administrator plays a vital role in managing office operations and ensuring the smooth day-to-day functioning of the workplace. Below is an overview of the job, including typical duties, required skills, and potential career growth. Key Responsibilities: • Office Administration:, • Overseeing the general office environment, maintaining supplies, organizing office layouts, and ensuring a clean and efficient workspace., • Managing office equipment and coordinating repairs or replacements., • Front Desk Operations:, • Serving as the primary point of contact at the front desk, greeting visitors, handling inquiries, and directing calls., • Managing the reception area to ensure a welcoming environment for clients, guests, and employees., • Administrative Support:, • Assisting executives and other staff members with tasks like scheduling meetings, managing calendars, and handling correspondence., • Preparing reports, presentations, and performing data entry tasks., • Delivery and Shipment Oversight:, • Overseeing incoming and outgoing deliveries, ensuring timely receipt and dispatch of shipments., • Coordinating with vendors, couriers, and internal departments to manage logistics and track shipments., • Communication Systems Management:, • Managing the staff communication system, ensuring effective and reliable communication channels within the office., • Troubleshooting communication issues and coordinating with IT support as needed., • Event Planning:, • Bilingual Spanish preferred required., • Organizational Skills: Ability to multitask, prioritize, and manage time effectively., • Communication Skills: Strong verbal and written communication skills for interacting with staff, clients, and vendors., • Technical Proficiency: Familiarity with office software such as Microsoft Office Suite (Word, Excel, Outlook) and office equipment., • Attention to Detail: Ensuring accuracy in tasks such as data entry and scheduling, • Problem-Solving: Ability to anticipate and resolve issues quickly and efficiently., • A high school diploma/GED required, • Certifications in office administration or business management can be beneficial.

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