Regulatory Coordinator

Roles And Responsibilities

• Prepare, manage, and submit all required Institutional Review Board (IRB) and other regulatory submissions, including initial protocols, amendments, continuing reviews, safety reports, and close-out documentation.
• Maintain all regulatory files in both paper and electronic formats, ensuring they are continuously updated and prepared for audits.
• Serve as the primary liaison between the research team, sponsors, and the IRB for all regulatory matters.
• Ensure timely renewals, amendments, and reporting of adverse events and protocol deviations.
• Perform other duties assigned to support overall regulatory functions and department.

Compliance and Quality Control

• Maintain investigator qualification documentation, including CVs, medical licenses, DEA registrations, financial disclosure forms, and training records, ensuring all documentation remains current and compliant.
• Track regulatory milestones, approval expirations, and submission deadlines to ensure timely completion of all study-related regulatory activities.
• Conduct periodic reviews of regulatory documentation to verify compliance with protocol requirements, sponsor expectations, Good Clinical Practice (GCP), and applicable regulations.
• Absorb and report on protocol deviation documentation, reporting, and follow-up activities as required by sponsors, IRBs, and organizational policies.
• Support corrective and preventive action (CAPA) activities related to audit findings, compliance concerns, and process improvement initiatives.
• Maintain all regulatory records in an audit-ready state and support sponsor, CRO, FDA, and internal audits and inspections.

Study Coordination

• Facilitate the regulatory aspects of study initiation, including site activation and contract review.
• Collaborate with the PI and research staff to complete all required regulatory documents (e.g., delegation of authority logs, conflict-of-interest forms).
• Prepare and finalize informed consent forms, ensuring they comply with institutional and sponsor requirements.
• Provide timely and accurate updates to the research team regarding protocol amendments, enrollment closures, and study close-outs.
• Maintain accurate tracking of all regulatory documents and approvals.
• Maintain and track study-specific training documentation, ensuring research personnel complete required protocol, GCP, safety, and sponsor-required training.
• Collaborate with cross-functional teams to support study startup, enrollment readiness, amendment implementation, and study close-out activities.
• Generate and maintain regulatory tracking logs and reports to support study oversight and compliance activities.