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 protocol compliance under the supervision of clinical research leadership. This role involves coordinating with research teams and sponsors to ensure adherence to clinical trial requirements, abstracting data, and maintaining communication for successful trial completion. The position requires strong organizational skills, knowledge of medical terminology, and the ability to manage multiple studies simultaneously in an on-site setting.
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, CLIENT_INDUSTRY.
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 onsite in Browns Mills, NJ. You will work closely with the Clinical Research Director, Principal Investigators, and the research team to ensure compliant, accurate data collection and timely regulatory submissions.
- Prepare, complete, and maintain IRB and sponsor regulatory submissions (initials, continuing reviews, amendments, safety reports)
- Document and report protocol deviations and reportable events to sponsors and IRBs
- Abstract, collect, and verify protocol-specific data from medical records and authorized sources
- Obtain informed consent following approved protocols and IRB requirements
- Maintain study files and regulatory documentation (eTMF or equivalent) to ensure inspection readiness
- Facilitate communication between the clinical research team and study sponsors, CROs, and internal stakeholders
- Produce routine and ad-hoc data reports to demonstrate study progress and impact
- Support study start-up, enrollment tracking, and monitoring activities
- Follow institutional policies, federal regulations, and GCP to ensure participant safety and data integrity
Minimum Qualifications
- Associate’s degree in a science-related field, or applicable certification with commensurate cardiovascular/research experience
- 1–2 years of medical-related clinical experience (entry-level candidates with relevant certification or cardiovascular experience will be considered)
- Completion (or willingness to complete within two weeks of hire) of Human Research Protection Foundational Training (HHS) and/or Good Clinical Practice (GCP) training (CITI or equivalent)
- Ability to obtain informed consent and interact professionally with patients, families, and clinical staff
- Strong written and verbal English communication skills
- Proficiency in MS Outlook, Word, Excel, and PowerPoint
- Excellent organizational skills and ability to prioritize multiple tasks and meet deadlines
- Ability to work independently and as part of a multidisciplinary team
Preferred Qualifications
- Bachelor’s degree in a related field
- Prior clinical research, regulatory submission, or cardiovascular experience
- Familiarity with electronic trial master file (eTMF) systems, iMedidata, and/or REDCap
- Experience with compliance management, auditing, or data management processes
- Multilingual candidates encouraged to apply
Compensation & Schedule
- Employment type: Full time
- Hours: 80 hours per pay period (as posted by the hiring organization)
- Minimum starting rate: $20.07 per hour
- Final base rate will consider relevant experience, education, credentials, and internal equity
What We Offer
Confidential Client offers an employee benefits package (where applicable) that may include health insurance for regularly budgeted positions of at least 30 hours/week, paid time off, 401(k) matching, tuition assistance, short- and long-term disability, life insurance, meal discounts, dependent care subsidies, adoption assistance, and free parking. Specific benefits will be confirmed by the hiring organization.
Supervision
This position does not require supervision of other staff. You will report to the Director of Clinical Research and/or Senior Clinical Research leadership.
Location
Onsite in Browns Mills, NJ. Applicants must be able to work at the client’s Browns Mills facility as required.
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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