Clinical Research Evaluation Supervisor - Military HIV Research Program
The Clinical Research Evaluation Unit Supervisor supports the Department of Laboratory Diagnostics and Monitoring for the Military HIV Research Program. Responsibilities include:
- Manage, coordinate and execute clinical testing of sexually transmitted infections, blood borne infections and transfusion transmissible infections in support of clinical laboratory mission and research studies.
- Oversight of US FDA Pre-Market Clinical Trials and other IRB approved clinical trials and non-clinical studies.
- Support IRB submissions
- Support development of Cooperative Research and Development Agreements (CRADAs) and Material Transfer Agreements (MTAs)
- Provide support for internal, manufacturer (sponsor), CAP, and/or US FDA 483 regulatory audits
- Serve as point of contact for manufacturer and sponsor study coordinators.
- Provide regular project updates to Principal Investigators.