Clinical Research Data and Regulatory Coordinator on-site
The Clinical Research Data and Regulatory Coordinator supports clinical research activities by managing regulatory submissions, data collection, and compliance with protocols and regulations. Working on-site, the coordinator collaborates with the clinical research team and investigators to ensure accurate data abstraction, informed consent, and timely reporting to sponsors and IRBs. This role requires strong organizational skills, knowledge of medical terminology, and proficiency in research data systems to facilitate successful clinical trial execution.
About Careertakes
👉 Important disclosure: Careertakes is a third-party recruiting platform supporting this hiring process. If selected, you will be employed directly by our client, Scientific & QA.
Applicants for this role may also receive access to additional matched opportunities through the Careertakes platform.
What You’ll Do
Confidential Client is seeking a Clinical Research Data and Regulatory Coordinator to support clinical trials and regulatory activities on-site in Pemberton, NJ. This role focuses on regulatory submissions, data abstraction and collection, and supporting the clinical research team to ensure trials are conducted in compliance with protocol, institutional policy, and applicable regulations.
- Prepare, submit, and maintain Institutional Review Board (IRB) regulatory documentation, including initial applications, continuing reviews, safety reports, amendments, and reportable-event filings.
- Coordinate communications between the clinical research team and study sponsors/monitoring bodies.
- Abstract and collect protocol-specific data from clinical records, clinicians, patients, and authorized caregivers using protocol-defined methods.
- Support informed-consent activities in accordance with approved protocols and IRB requirements.
- Assist with data queries, data cleaning, and preparing study reports that document research activity and impact.
- Work closely with Principal Investigators, Research Coordinators, and the Clinical Research Director to monitor study progress and support trial close-out activities.
- Maintain study documentation and support eTMF or other regulatory filing systems as required.
Qualifications
Required:
- 1–2 years of medical-related clinical experience (entry-level candidates with relevant certification or cardiovascular experience will be considered).
- Associate’s degree in a science-related field (applicable certification or commensurate cardiovascular experience may be accepted in lieu of degree).
- Certificate of successful completion of “Human Research Protection Foundational Training” (HHS) and/or “Good Clinical Practice” (GCP) training (CITI or equivalent) within two weeks of hire, if not already completed.
- Proficiency with MS Outlook, Word, Excel, and PowerPoint.
- Strong written and verbal communication skills in English.
- Ability to manage multiple priorities, meet deadlines, and perform multi-step procedures across several studies.
Preferred:
- Bachelor’s degree in a related field.
- Experience in cardiovascular research, regulatory submissions, data management, or clinical research coordination.
- Familiarity with REDCap, iMedidata, eTMF systems, GCP compliance, or auditing.
- Multilingual candidates are encouraged to apply.
Skills & Responsibilities (Summary)
- Strong knowledge of medical/scientific terminology and research methods.
- Excellent interpersonal skills; ability to handle sensitive situations professionally.
- Detail-oriented with strong organizational and time-management skills.
- Able to work both independently and collaboratively as part of a multidisciplinary research team.
- Commitment to compliance with applicable laws, institutional policies, and study protocols.
Schedule, Compensation & Benefits
- This is an on-site, full-time position based in Pemberton, NJ.
- Hours: 80 hours per pay period.
- Compensation: Minimum starting rate $20.07 per hour. Estimated annual pay for this role shown on the source posting: $67,032 per year (estimated).
- Benefits (for eligible employees): healthcare coverage for regularly budgeted positions ≥30 hours/week, generous paid time off, 401(k) matching, tuition assistance, short- and long-term disability, life insurance, meal discounts, dependent care subsidy, adoption assistance, and free parking.
- When determining base rate, factors such as relevant experience, education, credentials, and internal equity may be considered.
Location & On-site Requirements
- This role is on-site in Pemberton, New Jersey (Pemberton, NJ). Applicants must be able to reliably commute to the workplace location.
Reasonable Accommodations
Confidential Client and Careertakes provide reasonable accommodations throughout the application and hiring process for applicants with disabilities. If you require an accommodation, please notify us.
Equal Opportunity & Hiring Transparency
Careertakes and our client are Equal Opportunity Employers committed to building a diverse and inclusive workforce. We prohibit discrimination or harassment of any kind. To support a fair and efficient hiring process, AI tools may be used to assist with application review or resume screening. These tools do not replace human decision-making. Final hiring decisions are made by people.
If you have questions about how your data is used, please contact us directly.
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