Job Description
Job Description
Position Summary
Elite Clinical Network is seeking for a Regulatory Coordinator to play a key role in ensuring clinical trial compliance by preparing, submitting, and maintaining all regulatory documents required for study initiation and conduct. This role supports investigators, sponsors, and internal teams by ensuring adherence to FDA, IRB, and GCP regulations throughout the study lifecycle.
Key Responsibilities
- Prepare, submit, and maintain all essential regulatory documents (e.g., Form 1572, CVs, medical licenses, financial disclosures, IRB submissions, etc.) for clinical trials.
- Coordinate initial and continuing review submissions, protocol amendments, and safety reports to the Institutional Review Board (IRB).
- Maintain regulatory binders and trial master files to ensure completeness, accuracy, and compliance with sponsor and regulatory requirements.
- Track submission deadlines, approval expirations, and other critical regulatory timelines.
- Communicate with sponsors, CROs, and study monitors regarding regulatory documentation and site readiness.
- Assist in the preparation for sponsor audits and regulatory inspections.
- Collaborate with clinical and administrative staff to ensure all site and investigator documentation is current and compliant.
- Support the initiation, monitoring, and closeout of studies by ensuring regulatory documentation is accurate and up to date.
Qualifications
- Prior experience performing regulatory duties preferred but not mandatory.
- Strong understanding of FDA regulations, ICH-GCP guidelines, and IRB processes.
- Excellent organizational and communication skills with strong attention to detail.
- Proficient in Microsoft Office Suite and electronic regulatory systems (eReg, CTMS, or similar).
Preferred Skills
- Experience preparing regulatory submissions for multi-site clinical trials.
- Knowledge of Phase 1–4 clinical research processes.
- Familiarity with sponsor audits or FDA inspections.
- Certified Clinical Research Professional (CCRP) or equivalent certification (a plus).