Senior Regulatory Coordinator

📋 Description

• Directs regulatory oversight for clinical trials, which includes the preparation and submission of amendments, ongoing reviews, safety reports, deviations, and study close-out documentation to IRB, DSMC, PRMC, IBC, and other regulatory committees, ensuring adherence to institutional and federal guidelines.

• Keeps precise and audit-ready electronic regulatory binders and essential study documents, guaranteeing continuous compliance with GCP, protocol mandates, regulatory standards, and internal policies during monitoring visits and external audits.

• Acts as the primary regulatory liaison among investigators, research teams, sponsors, CROs, and regulatory agencies, facilitating prompt protocol approvals, addressing study-related inquiries, and updating key stakeholders on submission statuses.

• Offers regulatory expertise and operational support to investigators and research personnel by leading onboarding sessions, training, educational workshops, and creating reference materials pertinent to clinical trial policies, procedures, and compliance mandates.

• Works in conjunction with legal teams, sponsors, and study staff to review informed consent documents, ensure consistency in institutional and contractual terminology, and implement necessary protocol and staffing adjustments.

• Engages in departmental meetings, process enhancement initiatives, and cross-functional workgroups to improve regulatory operations, bolster compliance practices, and support effective execution of clinical research programs.

⛳️ Requirements

• Associate's degree with 5 years of experience in managing and conducting clinical trials in an academic environment OR a Bachelor's degree with 3 years of experience in managing and conducting clinical trials in an academic environment.

• Proficient understanding of clinical trials, and Federal, State, and Local Regulations, including IRB requirements, consent form, and protocol development.

🏝️ Benefits

• Health insurance

• 401(k) matching

• Flexible work hours

• Paid time off

• Remote work options