Clinical Research Manager
Current
Charlotte, North Carolina, United States
- Manage clinical research department including all projects/trials and staff CRAs for large, private GI group practice and ensure delivery and development of clinical operations team against key metrics
- Collaborate with all key internal and external stakeholders from start-up activity to study completion including communication with monitors from sponsor companies and CEO for marketing and clinical trial enrollment.
- Source and qualify potential studies for practice including budget negotiation/approval and contract review
- Coordinate all activities of Phase II-IV clinical research trials by obtaining informed consent, completing study procedures, and dispensing, accounting for study drug, and documenting drug accountability and compliance
- Consistently adhere to and monitor practice adherence to ICH guidelines, Good Clinical Practices, HIPAA, and all applicable regulations/guidelines related to clinical trials
- Create and update source documents at study start-up and as needed with protocol amendments through the duration of the study