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Job Description Job Title: Clinical Trials Assistant (CTA) Location: Remote Job Description: The Clinical Trials Assistant supports Clinical Operations to ensure studies are completed, on time, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines. The CTA will archive and organize clinical trial master file documents, including clinical study site documents, generate filing indexes and maintain currents lists of correspondence. Essential Duties and Responsibilities: • Assist in preparation of documents including regulatory document templates, study binders, study communications and presentations. Manage clinical, regulatory, and study-related essential documents such as study protocols, Informed Consent Forms, etc., • Assist with all aspects of initial study drug release including regulatory packet review and study-drug release., • Assist in the preparation and development of study-specific training materials., • Participate in the planning of investigator meetings., • Interact with sites as needed to respond to issues., • Handle incoming and outgoing shipments, as needed., • Monitor and track monitoring visit reports. Assist with tracking of clinical trial progress including status update reports, as required., • Participate in the review of clinical data at the case report form, data listing, and report table levels., • Collect enrollment updates and reports on a weekly basis., • Assist with tracking of clinical trial progress, as assigned., • Assist PM with set up and preparation of project meetings. May include scheduling the calls, gathering updates from the team, drafting, and finalizing of agenda, sending agenda to the team, and drafting and finalizing minutes., • File and QC trial master files., • Ensure documents are filed/uploaded into the eTMF in a timely and accurate manner., • Review and maintain up-to-date training records for the study team., • Document changes in study team members including updating the Study Contact Sheet., • Complete Study Plan Checklist for study Plans as assigned., • Identify and escalate issues appropriately., • May act as a central contact for the clinical team for designated project communications, correspondence, and associated documentation., • Performs data entry into designated clinical tracking systems in accordance with project requirements, including collection of information from designated clinical team members, CROs, vendors, etc., • BS/BA preferred. High school diploma/certificate or educational equivalent required., • Must possess a general knowledge of applicable clinical research requirements, including GCP and ICH guidelines., • Minimum of 2 years of clinical research experience required; one year CTA experience preferred but not required., • Demonstrated organizational and coordination skills with attention to detail., • Strong Microsoft Office skills., • Strong written and verbal communication skills., • Effective time management and organizational skills., • Attention to detail and accuracy in work., • Strong customer service orientation., • Ability to work effectively and efficiently handling multiple tasks simultaneously., • Ability to facilitate a teamwork philosophy with a positive attitude.

Job Description Job Summary: We are seeking a highly skilled Principal Regulatory Medical Writer to lead and contribute to key regulatory documentation efforts. The ideal candidate will have 4-8 years of experience in regulatory medical writing and a strong background in drafting essential regulatory documents, including Investigator’s Brochures (IBs), briefing books, responses to regulatory inquiries, and clinical study reports (CSRs). Additionally, this role will be responsible for leading contract medical writers, ensuring consistency, quality, and alignment with AMA and regulatory requirements. Responsibilities: • Author and edit high-quality regulatory documents, including IBs, briefing books, CSRs, and responses to regulatory authorities., • Lead and mentor contract medical writers, providing guidance, oversight, and quality assurance in regulatory document development., • Ensure regulatory compliance by following industry standards, guidelines, and best practices., • Collaborate cross-functionally with clinical, regulatory, and scientific teams to ensure clarity and accuracy in submissions., • Manage timelines and oversee document preparation schedules to meet regulatory submission deadlines., • Implement strategic input provided by the regulatory team to ensure alignment with strategy within and across content of documents., • Review and QC documents for consistency, scientific accuracy, and regulatory alignment. Qualifications: • Bachelor’s degree in life sciences (a higher degree such as Master’s, Ph.D., or PharmD is preferred)., • 4-8 years of experience in regulatory and/or clinical medical writing within the pharmaceutical or biotech industry., • Strong leadership skills with prior experience leading medical writers., • Deep knowledge of AMA style guide requirements., • Excellent writing and editing skills with the ability to convey complex scientific information clearly and concisely., • Detail-oriented with strong organizational skills to manage multiple projects simultaneously., • Proficiency in Microsoft Word and other document management tools (StartingPoint templates, Veeva RIM, etc)., • Expertise in writing and managing complex regulatory submission documents for clinical development programs., • Strong understanding of medical terminology and clinical trial methodology. This role is ideal for an experienced regulatory medical writer looking to take on leadership responsibilities while driving key regulatory submissions. The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary. As part of Aquestive’s employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place. Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education. Expected Base salary range: $96,000 to $150,000 USD

Job DescriptionJob description Job description Job Overview Board Certified Behavior Analyst (BCBA) Applied ABA Therapy is a premier provider of Applied Behavior Analysis (ABA) services, committed to transforming the lives of individuals with autism spectrum disorder (ASD) and other developmental disabilities. Our team of dedicated professionals delivers personalized, evidence-based interventions in home, school, and community settings to promote meaningful skill development and behavioral progress. At Applied ABA Therapy, we foster a culture of compassion, collaboration, and excellence, empowering our clients and their families to thrive. Join us in our mission to make a lasting impact! Job Overview Applied ABA Therapy is seeking a highly skilled and motivated Board Certified Behavior Analyst (BCBA) to join our growing team. The BCBA will play a critical role in designing and overseeing individualized ABA programs, conducting comprehensive assessments, and providing clinical supervision to behavior technicians. This position requires a proactive leader who is passionate about delivering high-quality, client-centered services and fostering positive outcomes. The BCBA will work closely with families, caregivers, and interdisciplinary professionals to ensure continuity of care and meaningful progress for each client. Key Responsibilities • Assessment and Program Development:, • Conduct comprehensive functional behavior assessments (FBAs) and skill-based assessments (e.g., VB-MAPP, ABLLS-R, AFLS) to identify client strengths and needs., • Develop individualized treatment plans that incorporate evidence-based strategies to address skill acquisition, behavior reduction, and functional life skills., • Create measurable goals and objectives aligned with client and family priorities., • Program Implementation and Oversight:, • Design and implement data-driven ABA interventions, utilizing techniques such as discrete trial training (DTT), naturalistic teaching, and pivotal response training (PRT)., • Oversee the implementation of behavior intervention plans (BIPs) by Registered Behavior Technicians (RBTs) and other support staff., • Regularly review and analyze data to evaluate client progress and modify interventions as needed to ensure effectiveness., • Supervision and Training:, • Provide ongoing clinical supervision and mentorship to RBTs and Behavior Technicians, ensuring fidelity of program implementation., • Conduct competency assessments and provide performance feedback to support staff development., • Deliver training sessions for staff and caregivers on ABA principles, behavior management strategies, and client-specific protocols., • Collaboration and Communication:, • Partner with families, caregivers, educators, and other professionals (e.g., speech therapists, occupational therapists) to promote consistency and generalization of skills across settings., • Facilitate parent training sessions to empower families to support their child’s progress at home and in the community., • Communicate effectively with stakeholders, providing clear updates on client progress and recommendations., • Documentation and Compliance:, • Maintain accurate and timely documentation, including session notes, progress reports, and insurance-required documentation., • Ensure all services comply with ethical standards and guidelines set by the Behavior Analyst Certification Board (BACB) and applicable state regulations., • Prepare reports for insurance providers, school districts, or other funding sources as required., • Professional Development:, • Stay current with advancements in the field of ABA through continuing education and professional development activities., • Participate in team meetings, case consultations, and Applied ABA Therapy’s internal training programs., • Education and Certification:, • Master’s degree in Applied Behavior Analysis, Psychology, Special Education, or a closely related field., • Current Board Certified Behavior Analyst (BCBA) certification through the Behavior Analyst Certification Board (BACB)., • Preferred NJ State licensure as a Licensed Board Certified Behavior Analyst., • Experience:, • Minimum of 2 years of experience as a BCBA, with a proven track record of developing and implementing ABA programs for individuals with ASD or developmental disabilities., • Experience supervising and training RBTs or other paraprofessionals in a clinical setting., • Familiarity with a variety of assessment tools (e.g., VB-MAPP, ABLLS-R, Vineland) and data collection platforms (e.g., CentralReach, Catalyst, Rethink)., • Skills and Competencies:, • Deep understanding of behavior analysis principles, including reinforcement, prompting, shaping, and functional communication training., • Strong analytical skills to interpret behavioral data and make data-driven decisions., • Exceptional leadership and interpersonal skills to motivate and guide a team., • Excellent written and verbal communication skills for interacting with clients, families, and professionals., • Proficiency in Microsoft Office Suite and electronic data collection systems., • Ability to manage multiple cases and prioritize tasks in a fast-paced environment., • Preferred Qualifications:, • Experience working in home-based, school-based, or community-based ABA programs., • Knowledge of insurance funding processes (e.g., Medicaid, private insurance) and authorization requirements., • The BCBA will primarily work in (remote, home-based, or daycare settings), with occasional travel to client locations., • Typical schedule: Monday through Friday, with occasional evening or weekend hours to accommodate client needs., • Competitive hourly rate based on experience and qualifications. At Applied ABA Therapy, we believe in fostering a workplace where passion meets purpose. As a BCBA, you will have the opportunity to make a tangible difference in the lives of clients and their families while growing professionally in a supportive, collaborative environment. Our commitment to innovation, ethical practice, and client-centered care sets us apart as a leader in the ABA field. Join our team and be part of a community dedicated to creating brighter futures! Equal Opportunity Employer Applied ABA Therapy is an equal opportunity employer and is committed to fostering a diverse and inclusive workplace. We welcome applications from all qualified candidates, regardless of race, ethnicity, gender, sexual orientation, religion, disability, or any other protected status. Contact Information For questions about this position, please contact our recruiting team at or visit our website at to learn more about our services and our team. Note: Applied ABA Therapy is proud to serve NJ and surrounding communities. Join us in our mission to deliver exceptional ABA services! Job Type: Part-time Pay: From $90.00 per hour Work Location: In person Powered by JazzHR kwJkqQk5GZ

Job Description Sub-Investigator Key Responsibilities: • Assist the Principal Investigator (PI) in overseeing and managing clinical trials conducted at the research site, ensuring adherence to the study protocol, Good Clinical Practice (GCP), ICH guidelines, and all applicable regulatory requirements., • Provide medical oversight and ensure the safety and well-being of study participants throughout the trial, under the supervision of the PI., • Perform delegated study-related duties as assigned by the PI, which may include comprehensive patient assessments, physical exams, medical histories, and eligibility screenings., • Review and interpret eligibility, laboratory results, ECGs, and other diagnostic tests as required by the protocol and under PI supervision., • Assist the PI in making medical decisions regarding participant care, adverse events, and protocol deviations., • Ensure accurate, complete, and timely collection and documentation of all study data., • Communicate effectively with the PI, study team, and, as delegated, with sponsors, Contract Research Organizations (CROs), Institutional Review Boards (IRBs), and regulatory authorities., • Assist with investigational product accountability, storage, and administration according to protocol., • Participate in site initiation visits, monitoring visits, audits, and inspections as required., • Maintain continuous medical education and stay current with advancements in clinical research and relevant therapeutic areas. Position Requirements: • Master’s degree in Nursing from an accredited program., • Current Nurse Practitioner certification (FNP, AGNP, or specialty certification) or Physician's Assistant (PA) certification and state licensure., • At least 3 years of experience in clinical research, either as a Sub-Investigator, research fellow, or similar role, with a strong understanding of clinical trial processes., • Demonstrated knowledge of ICH-GCP guidelines, FDA regulations, and other relevant ethical and regulatory requirements for clinical research., • Strong interpersonal and communication skills, with the ability to work effectively as part of a team., • Excellent clinical judgment and problem-solving abilities., • Meticulous attention to detail and strong organizational skills., • Ability to prioritize tasks and manage time efficiently., • Familiarity with clinical trial management systems (CTMS) and electronic data capture (EDC) systems is a plus., • Commitment to ethical conduct and patient safety. Location: This position requires NP travel to the location of the study/program participant/patient. Travel may be local or across state lines based on licensure to practice.

Job Description The Supply Chain Planner will manage material planning and purchasing activities to ensure on-time delivery and optimal inventory levels for clinical trial product manufacturing. This role coordinates with manufacturing, QA, QC, and cross-functional teams to align production schedules, resolve material shortages, and maintain supplier relationships. Responsibilities include developing replenishment strategies, managing supply forecasts, and driving process improvements within cGMP operations. Requirements Education: • Associate's degree required but prefer Bachelor's degree in Supply Chain, Engineering, Life Sciences, Information Systems, Business Management or related fields. Qualifications & Experience: • 3+ years of related experience in materials management and/or supply chain within cGMP operations. Cell therapy experience preferred., • Experience in material planning and/or finite scheduling in a medium to high volume environment., • Flexible and comfortable working with ambiguity. Strong understanding of current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA) and other regulatory requirements (EMA, TGA)., • Strong organizational, analytical, and time management skills., • Ability to work well in a team environment with a positive attitude and a willingness to assist other areas of the organization., • Excellent verbal and written communication skills as well as strong focus and attention to detail., • Independence and self-starting mentality with an ability to handle multiple tasks at once in a fast-paced environment., • APICS certification is a plus., • Proficiency in ERP and MRP systems (I.e., Oracle, SAP, QAD, IBP). Benefits Competitive hourly rate: | $27.01 – $34.3/hour (W-2 only, no C2C) 12-month contract with possible extension Health benefits, holiday pay, and 401(k) program Paid time off (UTO) and professional development support Employee referral bonus program Opportunity to contribute to high-impact projects with a leading biopharma company

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 Director of Regulatory Affairs oversees regulatory strategies for submissions and manages document deliveries to assure submission targets are met. Review of Sponsor submissions, as well as internal documents to assure proper regulatory records are accurate and complete to meet the FDA and GCP/ICH guidelines. The ideal candidate will have 10+ years of regulatory affairs experience on the site side or CRO. Responsibilities: • Liaison between ERG Regulatory Affairs and Sponsors’ Regulatory divisions., • Oversight of eReg across the organization., • General oversight of flow of Regulatory and IRB submissions, including meeting established submission deadlines to stay on track with company projections., • Oversight of regulatory-related start-up activities at new facilities (hospital review, Reliance Agreements, pharmacy, and lab documentation, etc.)., • Collaborate with Site Directors/Managers on feasibilities., • Collaborate with various ERG departments (Contracts, Recruitment, etc.) as needed for reg and IRB submission completion, facility approvals, physician onboarding and other related areas., • Interface with IRBs as necessary, • Reviews regulatory and related documents to ensure compliance., • Ensures on-time submissions and approvals of draft or amended protocols and/or Informed Consent Forms, • Collaborate with ERG and Site Leadership on Work Instruction development and implementation to maintain consistency across sites., • Collaborate with Recruitment Dept to create company-wide prescreening programs., • Provide sound regulatory advice/guidance to ERG Executive and Clinical Research staff., • Negotiate and manage regulatory time commitments and resources., • Manage COI disclosures as necessary., • Mentor, develop, and train staff., • Adhere to compliance and privacy/confidentiality requirements and standards., • Has a working knowledge of GCP/ICH guidelines, internal SOPs, and individual protocols, • A minimum of ten years of experience in clinical research Regulatory Affairs required., • Regulatory Affairs Certification preferred but not required., • Experience with IRB submissions, • Clinical research experience preferred but not required., • Good working knowledge of medical terminology and the clinical research process, • Expert computer skills, including knowledge of all components of Microsoft Office are required.

The Future Talent Program features internships with a duration of up to 12 weeks and will include one or more projects.

As a Head of Product at EVYD Technology US, you will lead the strategy, development, and execution of our next-generation AI-powered clinical trial optimization platform.

GCTO is a global organization operating in over 50 countries and is responsible for the delivery of our company's diverse development portfolio comprising over 200 clinical trials in compliance with global and local regulations. Our company's Global Clinical Trial Operations (GCTO) regional team is

Essential Duties and Responsibilities: Provide guidance to the Transparency team on overall Clinical Trial processes and conduct.Perform required clinical trial registration and/or results disclosure activities as necessary.Assess the overall process between the Clinical Management team and the CTT&

The Future Talent Program features internships that last up to 12 weeks and will include one or more projects. Deliver a capstone presentation illustrating internship objectives and activities. Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research

Job Description Job Summary: Aquestive Therapeutics is a growth-stage biopharmaceutical company at the forefront of advancing medicines to bring meaningful improvement to patients’ lives through innovative science and delivery technologies. the benefit of patients. Our proprietary PharmFilm® oral film dose form platform and Adrenaverse™ epinephrine prodrug platform enable the development of high-performance therapeutics delivered via oral, topical and transdermal routes. Aquestive has already brought four Rx products to market through licensing partnerships and a growing portfolio of DTC products, establishing us as a leader in applications of oral thin film technology. We are focused on an expanding and robust proprietary pipeline of Rx drug products led by Anaphylm™ – an epinephrine prodrug sublingual film for severe allergic reactions that is the first and only orally delivered, needle-free epinephrine product candidate – and AQST-108 – a topical epinephrine prodrug gel for treatment of alopecia areata. These innovative programs exemplify our mission to provide patient-centric treatments to underserved markets and are the key drivers of our growth plan. We are seeking an accomplished Senior Vice President of Research & Development to join our executive leadership team and drive the next stage of Aquestive’s innovation and execution journey. The SVP R&D will provide visionary and hands-on leadership across all R&D functions – from late stage discovery (e.g. Adrenoverse ™) to early formulation and preclinical research through clinical development, regulatory approval, and commercialization – to advance our new product pipeline and expand the impact of our technology and therapeutic platforms. This executive will shape and execute R&D strategy with a focus on advancing critical programs (for example, shepherding Anaphylm through NDA submission and launch preparation, and progressing AQST-108 into Phase 2 clinical trials) while fostering innovation for future pipeline opportunities. The role requires a dynamic leader who can ensure NDA filings, clinical trials, and product launches are delivered successfully, build and mentor a high-performing R&D organization, and serve as a clear, investor-facing champion for Aquestive’s scientific vision and achievements. This role is a member of the Executive Leadership Team (ELT) and reports to the CEO. Responsibilities: • Develop and lead an integrated R&D strategy aligned with corporate objectives and patient-centric innovation., • Oversee advancement of key programs including Anaphylm™ (epinephrine sublingual film) through NDA submission and launch, and AQST-108 (topical epinephrine) into Phase 2 trials., • Lead all R&D functions: discovery, formulation, preclinical, clinical, regulatory, and CMC., • Cultivate a high-performing R&D organization that emphasizes agility, innovation, and accountability., • Drive integration of core technologies (PharmFilm® and Adrenaverse™) into new and existing pipeline assets., • Serve as a cross-functional partner with Medical, Regulatory, Commercial, and Manufacturing., • Ensure quality and compliance across all R&D activities; proactively manage risk., • Ph.D. in Pharmaceutical Sciences, Chemistry, Biomedical Engineering, or related field required (M.D. with equivalent R&D leadership experience also considered)., • 15+ years in pharmaceutical/biotech R 5+ years in senior leadership roles., • Proven experience in advancing drug candidates through regulatory approval and launch., • Expertise in non-invasive delivery systems highly desirable., • Strong understanding of regulatory requirements (IND/NDA), clinical trial design, and CMC., • Demonstrated ability to build and scale high-performing, cross-disciplinary R&D teams., • Strong financial, strategic planning, and communication skills. As part of Aquestive’s employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place. Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education. Expected Base salary range: $300,000 to $350,000 USD

IQVIA is looking for qualified Registered Nurses interested in community and clinical trial work to visit clinical trial patients in their homes. Are you a Registered Nurse interested in Clinical Trial work?. You will have a flexible schedule, an opportunity to travel, grow and expand into new oppor

Work with Clinical Operations Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating model. The Office-Based Clinical Trial Associate (CTA) will perform tasks related to supporting operational strategy and and

Work with Clinical Operations Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating model. The remote-based Clinical Trial Associate (CTA) will perform tasks related to supporting operational strategy and and