This role will include clinical trial management of Industry and NIH Sponsored Clinical Trials (Phase II-III), and Investigator Initiated Studies. Study start-up: IRB submissions, assist with database creation and development of study collection materials. Study Maintenance: Screen, enroll, schedule, and conduct study visits. Data collection and maintenance of eCRFs ensuring trial compliance. Regulatory Maintenance: IRB amendments and renewals, and maintaining the regulatory binder.
Expert level knowledge, skills, and abilities within all 8 competency domains is expected:
1. Scientific Concepts and Research Design
2. Ethical Participant Safety Considerations
3. Investigational Products Development and Regulation
4. Clinical Study Operations (GCPs)
5. Study and Site Management
6. Data Management and Informatics
7. Leadership and Professionalism
8. Communication and Teamwork
Supervision Received: This position reports directly to Faculty Principal Investigator, with daily supervision from the CRC-Lead.
Supervision Exercised: Could provide Functional supervision (likely in limited capacity such as training) of staff in titles within the CRC Career Ladder.