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Job Summary: We are seeking a highly experienced Clinical Studies Coordinator to lead and execute end-to-end clinical studies supporting FDA submissions (510(k)), pilot and feasibility studies, post-market clinical follow-up, and real-world evidence generation. This role is hands-on, operational, and strategic. The ideal candidate has deep experience managing medical device and digital health clinical studies, working directly with FDA-facing documentation, IRBs, investigators, CROs, and internal regulatory, engineering, and product teams. This position plays a critical role in de-risking regulatory submissions, ensuring GCP compliance, and translating clinical evidence into successful regulatory and commercial outcomes. Key Responsibilities: • Lead the planning, coordination, and execution of clinical studies, including:, • Pilot/feasibility studies, • IDE-exempt and IDE-supporting studies, • Pivotal and non-pivotal studies for FDA 510(k) submissions, • Post-market surveillance (PMS) and post-market clinical follow-up (PMCF), • Real-world evidence (RWE) and usability studies, • Develop and manage study timelines, milestones, and deliverables, • Ensure studies are conducted in compliance with GCP,FDA regulations, ISO 14155 and other applicable standards., • Prepare, review, and maintain clinical documentation for regulatory submissions, including:, • Clinical Study Plans (CSPs), • Protocols and amendments, • Informed Consent Forms (ICFs), • Statistical Analysis Plans (SAPs) (in collaboration with biostatistics), • Clinical Study Reports (CSRs), • Support subject recruitment and enrollment activities, • Conduct blood draws on study subjects., • Process blood samples., • Initiate IV’s when the MD is unavailable., • Supervise the maintenance of laboratory equipment, including calibration records., • Maintain clinical staff training documentation., • 7 – 10 years of related experience or equivalent combination of education and experience., • Excellent communication skills (both written and oral)., • Knowledge of clinical databases and data management systems, • Ability to be an integral part of an innovative, fast-paced product development team., • Ability to manage multiple concurrent studies is essential, • Bachelor’s degree in Life Sciences, Biostatistics, Health Informatics, Biomedical Engineering, • Experience with clinical studies and interfacing with IRB., • Clinical research certifications Physical requirements/Work Environment: This position primarily works in an office as well as laboratory environment. It requires frequent sitting, standing and walking. Work in a lab involves potential exposure to blood borne pathogens, as well as needles. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings, walking in the facilities, or processing tissue samples, blood, etc. Some local travel is necessary so the ability to operate a motor vehicle and maintain a valid Driver’s license is required. Some travel to clinical sites might be required. The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.

Clinical Operations Manager Kelly Science and Clinical is hiring for one of our growing Site Network Clients to work as a direct employee onsite in San Diego CA. • Opportunity: Direct hire, • Location: San Diego CA – On-site, • Travel: 5-10% as needed, • Salary: 95,000.00 – 105,000.00 annually, • In addition to benefits such as Medical, Dental, Vision, 401k, PTO and more About the Company: We are people with a purpose, dedicated to advancing medical innovation and healing technology through groundbreaking research, diligent patient care and strong executive management. Our hands-on management team and medical staff are committed to rapid, efficient trials that bring life-changing drugs to market faster; our research staff brings years and years of “in the trenches” experience conducting Phase 1-4 clinical studies. And each one is dedicated to curing disease and improving individual quality of life. Mission Statement: Our mission is to advance medical research by enrolling diverse populations in high-quality clinical trials. We are committed to maintaining the highest standards of integrity and excellence, and to ensuring that every participant receives respectful and compassionate care. We strive to build a tightly knit, supportive and collaborative environment where our team members can thrive and make meaningful contributions to human health. About the Role: The Clinical Operations Manager will oversee the day-to-day functions of the clinic, manage the office personnel, as well as manage daily operational and administrative activities. This individual will act as a liaison between patients, medical staff, clinic staff, and management to ensure optimal clinic functioning. Additionally, the Manager will play an essential role in ensuring policies and procedures, ensure that the clinic delivers exceptional patient care, and function efficiently. ESSENTIAL DUTIES AND RESPONSIBILITIESinclude the following. Other duties may be assigned. • Comply with all company policies, procedures and conduct., • Strictly adhere to confidentiality and compliance standards., • Manage and train clinic site personnel., • Identify and implement strategies to expand the research capabilities at the site - in line with the overall site business plan., • Oversee the implementation and maintenance of ACN quality standards at the site ensuring that the conduct of clinical studies and the collection of patient data is in accordance with ICH GCPs., • Work with the Medical Director/PI to address any study and/or clinical quality related matters., • Ensure timely and appropriate communications occur with Sponsors and IRBs as necessary., • Develop site staffing plans to ensure the successful and efficient conduct of research studies. Identify and fulfil any site resource needs which are necessary to successfully conduct and/or recruit research studies., • Oversee the development of the patient recruitment plan and patient outreach process. Make ongoing adjustments/modifications to recruitment strategies based upon the timely review of results to ensure financial and study-specific targets. Closely collaborate with any external vendors to facilitate successful patient enrollment strategies., • Read, comprehend and communicate study protocols., • Oversee SIV, PSDV and IMV., • Manage and facilitate study startup documentation, training, supplies and timelines of study protocols., • Work closely with CRO/CRA/IRB., • Maintain site regulatory files., • Document temperatures for IP stored on-site., • Audit study e-source documentation to comply with study protocols., • Other tasks as assigned. QUALIFICATION REQUIREMENTS: The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. EDUCATION and EXPERIENCE: • Bachelor’s degree preferred in healthcare or equivalent clinical research experience., • 5+ years of clinical management experience or equivalent applicable experience in clinical research industry, • 3 years' experience working as a Clinical Research Coordinator, required., • Comprehensive knowledge of FDA, GCP & confidentiality., • Proven success in managing teams and working in direct patient care, required., • Proficient problem-solving skills & conflict resolution., • Proficient in Microsoft Word, Excel and PDF., • Excellent verbal and written communication skills., • A proven ability to constantly prioritize multiple projects in a rapidly changing environment., • Must be comfortable with a rapid-growth company.

Job DescriptionWe are seeking a motivated Assistant Recruitment Coordinator to join our research team! The individual in this entry-level position is responsible for performing patient recruitment mainly over the phone. The Assistant Recruitment Coordinator will identify eligible research subjects for active clinical trials to ensure sponsor and trial timelines are met. Room for growth.Job Duties: • Ability to professionally conduct patient interviews and medical history intakes, mainly over the phone, • Comfortable leaving voicemails or being on the phone for extended amounts of time to pre-screen and register interested participants into site database, • Demonstrate a strong working knowledge of medical terminology, medical conditions/diagnoses, and related therapies to appropriately recruit eligible patients, • Meet key performance metrics and other quality assurance requirements, • Demonstrate understanding of clinical trials and enrollment procedures within GCP (Good Clinical Practice) guidelines. Training on the job., • Comprehend and transition between numerous clinical trials at any given time, • Act as the liaison between clinicians and study coordinators to increase enrollment activities, • Understand the key factors that draw patients to clinical trials to assist in developing successful recruitment and retention strategies, • Assist in strategizing and problem-solving to overcome enrollment obstacles, • Additionally, there will be various administrative duties, including but not limited to data entry, making copies, filing, and scanning documents. Qualifications, • Bachelor’s degree preferred, • Minimum of one (1) year of recruiting or marketing experience preferred, • Phone experience preferred, • Must possess a professional and friendly attitude and be able to quickly develop a rapport with potential patients, mainly over the phone, • Possess excellent communication skills with the ability to provide a high volume of service, along with a high quality of work., • Hard-working team player, • Ability to multitask and have a strong attention to detail., • Ability to learn and navigate new software quickly, and be adept with computers Position Type:Full-time (40hrs/week). Monday through Friday (9 AM - 5:30 PM); schedule flexibility is also required for occasional community event programs, which may fall on weekends.*This is a hybrid position: WFH with recurring in-person meetings 2x/month in office

Clinical Research Coordinator - Dermatology Clinic About the Role We are seeking a dedicated Clinical Research Coordinator (CRC) to support dermatology clinical trials. Key Responsibilities This role includes, but is not limited to, the following: * Manage and oversee 11-15 active clinical trial

Under supervision of the Study Principal Investigator (PI), the Clinical Research Coordinator supports a federal grant-funded clinical trial according to Good Clinical Practices (GCP), internal standard operating procedure (SOPs), and University policies and procedures. A minimum of 1 year of relate

The incumbent is responsible for supporting and coordinating all aspects of this clinical trial for protocol specific requirements, research procedures, research chart preparation, data collection, and record keeping. A minimum of 1 year of related work experience as a clinical research coordinator

Under supervision of the Clinical Research Manager of the Clinical Trials Unit, the Clinical Research Coordinator supports the clinical research efforts of the Cancer Center by providing comprehensive coordination and data management of multiple Phase I-IV cancer-related protocols according to Good

Independently or under the supervision of the Clinical Research Manager and the Assistant Director of Clinical Research Operations, the incumbent is responsible for coordinating clinical trials in the UCI Center for Clinical Research (CCR). The UCI Center for Clinical Research (CCR) is driven to imp

Under the supervision of the Clinical Research Manager (CRM) within the Clinical Trials Unit, the Senior Clinical Research Coordinator (SCRC) supports the clinical research efforts of the Cancer Center by providing comprehensive coordination and data management for complicated Phase I-IV cancerproto

Job DescriptionThe Stroke Research Coordinator is a nurse responsible for the coordination of stroke research projects and compliance with Standard Operating Procedures, stroke education to patients, staff, families and community members and follow-up phone call and data collection. The Stroke Research Coordinator works in collaboration with the SCC, the Stroke Medical Director and all staff who interact with stroke patients to ensure best practices are provided according to the AHA Clinical Practice Guidelines. Requirements: • Graduate nurse of an accredited school of nursing preferred., • Licensure: LVN or RN licensed in the state of California- required., • Minimum of 2 years nursing practice with 2 years of neuro experience preferred., • Experience with education and data collection preferred., • Experience with computer and other productivity applications preferred., • Spanish speaking preferred., • Able to demonstrate the following core competencies: critical thinking, organizational skills, technical skills, communication, interpersonal skills, planning, intervention, evaluation, flexibility and professional accountability. Benefits: • Medical, dental, and vision coverage is provided for all full time and part-time employees*, • Medical is 100% employer-paid including dependents*, • Employee Assistance Program, • Basic Life and AD&D, • 401k plan with company match, • Generous PTO plan*, • Pet Insurance Discount Program*

Description Under the supervision of the Medical Office Administrator, the Associate Clinical Research Coordinator oversees the day to day functions of multiple clinical research studies. Requsition ID: 411038 Company: Providence Jobs Job Category: Research Job Function: Clinical Support Job Schedul

Job DescriptionBenefits: • Dental insurance, • Health insurance, • Paid time off, • Vision insurance Our clinical research team is expanding! We are seeking a Clinical Research Patient Recruitment Coordinator, who will play a crucial role in supporting clinical research activities, ensuring adherence to protocols, and contributing to the advancement of medical knowledge. The Patient Recruitment Coordinator is responsible for developing and implementing recruitment strategies to identify and enroll participants for clinical trials. You will collaborate with research teams, healthcare providers, and community organizations to enhance patient outreach and ensure compliance with regulatory standards. Key Responsibilities: • Develop and implement patient recruitment strategies for clinical trials., • Conduct outreach to potential participants through various channels, including internal/external healthcare providers, community events, and social media., • Screen and pre-qualify candidates based on study criteria and eligibility requirements., • Maintain detailed records of recruitment efforts, participant interactions, and enrollment metrics., • Coordinate and attend community engagement events to promote clinical trials and raise awareness., • Provide information and support to potential participants about study protocols, benefits, and risks., • Collaborate with the research team to optimize recruitment processes and address any challenges., • Ensure compliance with ethical and regulatory guidelines in all recruitment activities., • Monitor and report on recruitment progress, adjusting strategies as necessary to meet enrollment goals., • Facilitate communication between participants and study staff throughout the trial. Qualifications: • Bachelors degree in a relevant field (e.g., life sciences, nursing, public health) or equivalent experience., • Previous experience in clinical research or patient recruitment is preferred., • Strong interpersonal and communication skills, with the ability to build rapport with diverse populations., • Excellent organizational skills and attention to detail., • Familiarity with clinical trial protocols and regulatory requirements is a plus., • Proficiency in using recruitment software and databases., • Ability to work independently and as part of a team., • Willingness to travel locally for outreach activities as needed. Compensation and Benefits: • PNS offers a competitive compensation package including; medical, dental, vision, and paid time off for full time employees., • Hourly rate based on skill, experience, and tenure of your profession.

Under the direction of the Program Manager, the Assistant Clinical Research Coordinator supports the research efforts of several regional projects. Prior research experience with demonstrated independent responsibilities and activities. Conducts research protocols with critical attention to detail.

Job DescriptionIrvine Clinical Research is the largest independent memory research center on the West Coast. Alzheimer's Disease is a serious cognitive illness that affects millions of people each year. Every research trial brings us closer to finding a treatment or cure for Alzheimer's Disease. A recent study conducted at Irvine Clinical Research was successful in slowing cognitive decline by as much as 27%. Irvine Clinical Research is looking for a friendly, outgoing person to join our team as a Clinical Research Recruitment Coordinator. You will be speaking with potential study participants about their health concerns, especially around memory loss, and when appropriate, presenting research as a care option.In this role, expect to • Recruit study participants via short telephone interviews; make outbound phone calls to achieve appointment scheduling goal, • Build rapport with potential participants to ensure engagement and retention, • Promote Irvine Clinical Research's services and the opportunity to advance the fight against Alzheimer's Disease via study participation, • Work independently while still being accountable to recruitment goals, • Input data into electronic systems in a consistently timely and accurate manner, • Assist with other recruitment, marketing, and outreach efforts as neededTo succeed in this role, you have, • A welcoming, friendly, and professional attitude and demeanor that you bring with you every day, • Ability to consistently build trust and rapport with persons concerned about memory, • High attention to detail for all of your work responsibilities, • Time management skills to coordinate and manage recruitment calls efficiently Nice to have, but not essential, • Experience speaking with people with cognitive issues or older adults, • Call center or clinical research experience

Job Description Position Summary: The Clinical Research Coordinator undertakes the performance of clinical trials. The individual seeking this position will be responsible for all aspects of completion of the research study. Ideal candidate will possess outstanding organization, communication skills, and an ability to adjust and interact with various types of people. Must be a team player, maintain confidentiality, and be comfortable working in the medical field. Candidate will demonstrate customer service that is compassionate, courteous, friendly, non-judgmental, and demonstrate a respect for privacy. Location: Fullerton, CA Work Schedule: Monday through Friday: 8:00 am - 5:00 pm, additional hours as necessary. Education: Some college experience required. Bachelor’s degree preferred but not required. Experience: Must have a minimum of 6 months of experience in clinical research. Preference given for individuals who have more than 12 months experience in the above field. Preference given for individuals with experience in phlebotomy. CRC duties include, but not limited to: · Communicates with principal and sub-investigators regarding protocol changes, subject updates, and recruitment strategies. · Maintains constant availability to subjects for updates, questions, and emergencies. · Performs face-to-face and telephone protocol-specified research visits. · Maintains an up to date EDC system, and answers queries in a timely manner. · Implements IRB approved protocol changes to visits and source documentation. · Ensures accurate and secure study information, meeting the guideline of ALCOA for data integrity. · Obtains laboratory samples, ECGs, and vitals. · Obtains, reviews, and records medical history for the subject during the duration of the trial. · Communicates with subjects and/or caregiver regarding medication changes, adverse events, scheduling visits, and study drug compliance. · Documents adverse events as reported by the study participant, and meets mandatory reporting guidelines per sponsor and/or IRB · Performs initial and revised informed consent process with subject and/or caregiver. · Administers scales, diagnostic testing, and other study assessments. · Follows and observes HIPAA guidelines for the protection of PHI for research subjects. Additional CRC Duties: · Ensures adequate temperature regulation occurs for investigational products, laboratory supplies, and other temperature-specific materials. · Maintains inventory and accountability of investigational product. · Administration of study medication and/or application of study devices, when appropriate · Instructs subjects on the proper administration of investigational product and/or accompanying devices or diaries. · Contacts potential subjects and administers IRB approved telephone screening questionnaire. · Informs physicians and other healthcare professionals of available research opportunities. Job Type: Full-time Job Location: Fullerton CA Required education: · Some college experience, preference given for applicants with a college degree Required experience: · Must have a minimum of 6 months of experience in clinical research Company DescriptionNeurology medical practice.Neurology medical practice.

A healthcare organization in Anaheim, California is seeking a Research Administration Specialist to coordinate clinical research project applications and assist with daily administrative operations. Candidates should have a bachelor's degree, experience in medical or research administration, and pro

Job Description The Marketing Coordinator plays a key role in executing and optimizing strategic marketing initiatives that elevate Stanbridge University’s brand, drive enrollment growth, and strengthen engagement across multiple channels. Reporting to the Director of Marketing and Marketing Operations Manager, this role blends campaign execution with performance analytics, vendor coordination, and continuous optimization. This is an ideal opportunity for a data-driven marketing professional who thrives on performance metrics, enjoys translating analytics into actionable strategy, and wants exposure to multi-channel campaign management within a fast-paced higher education environment. Coordinators may develop deeper specialization in content marketing, conversion rate optimization (CRO), CRM automation, or analytics while contributing broadly across the marketing function. This role offers exposure to strategic marketing planning and cross-functional decision-making within a growing university environment. Essential Functions: • Monitor and analyze campaign data on a weekly, monthly, and quarterly basis to evaluate performance and identify trends., • Recommend and implement optimizations for digital and non-digital marketing campaigns based on data insights., • Ensure marketing calendar activities are executed on time and in alignment with strategic objectives., • Coordinate, negotiate, and maintain communication with advertising vendors to support campaigns., • Conduct market research, surveys, and student data analysis to inform marketing strategies., • Develop and deliver presentations of data-driven findings and proposed solutions to the marketing team., • Partner with other departments to ensure alignment and consistency across marketing initiatives., • Lead or contribute to specialized projects in areas such as content marketing, conversion rate optimization, CRM automation, or analytics., • Perform additional duties as assigned by the Director of Marketing and Marketing Operations Manager.Qualifications:, • Bachelor’s degree from an accredited college or university (preferred in Marketing, Communications, Business, or related field)., • Strong ability to interpret and report on analytics data, with a focus on identifying actionable insights., • Demonstrated experience supporting campaigns with measurable performance outcomes (CTR, CPC, conversion rate, engagement growth, or similar KPIs)., • Proficiency in Excel, including pivot tables, data analysis, and performance reporting., • Experience with performance or content marketing platforms such as Sprout Social, WordPress, SEMRush, Google Analytics, Meta Ads, TikTok, Mailchimp, survey tools, and social media analytics., • Ability to communicate data insights clearly and persuasively to stakeholders., • Critical thinking skills with the ability to work independently and support innovative solutions., • Highly organized, detail-oriented, and capable of managing multiple projects in a fast-paced environment., • Professional demeanor and collaborative approach to team-based projects. Marketing Specialist, Digital Marketing Specialist, Social Media Specialist, Marketing Associate, Digital Marketing Associate Marketing & Communications Associate, Digital Marketing Coordinator, Marketing & Communications Coordinator, Marketing Representative, Marketing & Outreach Representative, Social Media Promotions Representative. Candidates with experience supporting performance-driven campaigns and measurable marketing outcomes are strongly encouraged to apply. Conditions of Employment: • A job-related assessment may be required during the interview process., • Must be able to perform each essential duty satisfactorily and be physically present in the office (unless otherwise noted)., • Employment verification will be conducted to validate work experience per accreditation standards., • Offers of employment are contingent upon the successful completion of a background check., • Official transcripts are required prior to hire. Degrees earned outside the United States must be evaluated by a recognized credential evaluation service to determine U.S. degree equivalency and applicable subject-area coursework., • Must be legally authorized to work in the United States at the time of hire and must maintain work authorization throughout employment. Stanbridge University does not provide employment visa sponsorship for this position., • Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Work Environment:, • Standard office/classroom/lab or clinical setting., • Duties are typically performed while sitting at a desk or computer workstation., • May include time spent in skills labs or bedside environments as required by the program., • Regular collaboration with team members, other university departments, and external vendors., • Subject to frequent interruptions, noise from talking or office equipment, and demanding timelines.Physical Demands:, • Regularly sits for extended periods., • Physical ability to perform program- or department-related duties., • Proficient in using electronic keyboards and office equipment., • Effective verbal communication via phone and in person., • Ability to read fine print, operate computers, and understand voices clearly., • Able to lift, carry, and/or move objects weighing 10–25 pounds as needed.Employee Benefits:, • Health Care Plan (Medical, Dental & Vision), • Retirement Plan (401k), • Exciting university events, • Seasonal motivational health and wellness challenges, • Work/Life Balance initiatives, • Onsite wellness program / Staff Chiropractor, • Life Insurance (Basic, Voluntary & AD&D), • Paid Time Off (Vacation, Sick & Public Holidays), • Family Leave (Maternity, Paternity)Institutional Values:, • Diversity and Inclusion: Stanbridge University’s motto, “Strength through Diversity,” reflects our deep commitment to honoring the diverse backgrounds of our students, faculty, staff, and surrounding communities. We strive to build an inclusive learning environment and uphold anti-discrimination practices in all aspects of university life., • Innovation and Technology: We embrace cutting-edge technology to enhance student learning through interactive, hands-on experiences, including virtual reality and simulation labs—ensuring students are prepared for the demands of modern healthcare practice.