- Oversee and continuously improve the clinical research quality management system in partnership with senior clinical and research leadership.
- Perform internal audits to ensure compliance with sponsor protocols, GCP, SOPs, and regulations.
- Develop, update, and maintain SOPs and workflows to ensure operational consistency.
- Manage internal investigations and lead the Corrective and Preventive Action (CAPA) program.
- Prepare for and assist with FDA inspections, including hosting inspections when required.
- Design and conduct training programs for physicians, APPs, and research coordinators.
- Serve as a member of the Research Leadership Team to assist with study selection and staff hiring.
- Provide research regulatory advice and mentorship to staff across various committees.
GCPQuality Assurance