Clinical Research Regulatory Specialist C

About the role

Leads regulatory operations for clinical research, independently managing submissions to IRBs, committees, sponsors, CROs, and regulatory agencies. Oversees regulatory documentation, resolves complex compliance issues, and directs initiation, monitoring, audit, and close-out visits. Guides development of regulatory tools and processes, provides expert regulatory and compliance guidance, and mentors junior staff in regulatory practices and study oversight.

Responsibilities

• Lead the coordination of unit clinical research, including but not limited to Phase I-IV clinical trials.
• Independently prepare and process all regulatory documentation/applications