- Oversee and coordinate regulatory documents and activities for regional clinical research studies.
- Manage regulatory start-up timelines and staff activities.
- Lead regulatory aspects of audits and inspections.
- Oversee preparation, submission, and maintenance of IRB submissions, amendments, and renewals.
- Mentor, train, and manage team members, including performance reviews and hiring.
- Collaborate with site leadership, principal investigators, sponsors, and CROs.
- Identify and implement process improvements for regulatory efficiency.
GCPTeam managementProcess improvement