Regulatory Affairs Coordinator
Schedule
4 days onsite and 1 day remote
About the role
We are seeking a detail-oriented Regulatory Coordinator to support a growing Clinical Research team. This individual will play a critical role in ensuring regulatory compliance and maintaining accurate documentation for multiple clinical research studies. The position will support study startup, maintenance, and closeout activities while serving as a key liaison between investigators, sponsors, and institutional regulatory bodies. This is an exciting opportunity to join a high-impact research environment supporting several active clinical trials, including studies that may be subject to FDA inspection.
Responsibilities
- Prepare, submit, and track all Institutional Review Board (IRB) applications, amendments, continuing reviews, and reportable events to ensure timely approvals and ongoing compliance.
- Maintain complete and accurate regulatory binders (electronic and physical) for assigned studies.
- Manage essential study documentation including:
- FDA Form 1572s
- Delegation of Authority (DOA) logs
- Financial Disclosure Forms (FDFs)
- Investigator and staff CVs
- Medical licenses
- Training records
- Other required regulatory documents
- Develop and communicate timelines for regulatory submissions and approvals.
- Provide regular status updates to investigators, study coordinators, sponsors, and research leadership.
- Conduct internal quality control reviews of regulatory files across research locations to ensure compliance with:
- Good Clinical Practice (GCP)
- International Council for Harmonisation (ICH) Guidelines
- HIPAA regulations
- FDA requirements
- Support study startup, maintenance, closeout activities, and audit readiness initiatives.
- Assist in preparing for sponsor, regulatory, and FDA inspections.
Required Qualifications
- Bachelor's Degree (BS) required
- 2+ years of clinical research regulatory experience
- Experience preparing and managing IRB submissions
- Knowledge of FDA regulations, GCP, ICH, and HIPAA requirements
- Experience maintaining regulatory documents and essential study files
- Strong organizational skills with exceptional attention to detail
- Advanced proficiency with Microsoft Office Suite
Preferred Qualifications
- Master's Degree (MS)
- Experience supporting clinical trials in Neurology
- Experience working in an academic medical center, hospital, or clinical research setting
- Experience preparing studies for regulatory audits or FDA inspections
Pay
The pay range for this position is $70,000.00 – $100,000.00/yr. Individual compensation offered within this range will depend on qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.
Workplace Type
This is a fully onsite position in Camden, NJ.