Research Supervisor-Regulatory

• Right-click for referral link
• Job Title: Research Supervisor-Regulatory
• Department: Office of Clinical Trials
• Full/Part Time: Full
• Req Number: UHS-30973

Responsible for providing, planning, and ensuring that UTMC maintains compliance with all Good Clinical Practice and U.S. Food and Drug Administration, as well as any other appropriate regulatory agencies, regulations. Plays a crucial role in ensuring compliance with regulatory requirements throughout the lifecycle of clinical trials. This position offers an exciting opportunity to contribute to the development of innovative medical treatments while adhering to stringent regulatory standards. Oversees the initiation and maintenance of all regulatory documents necessary for submission to Institutional Review Boards, study sponsors, and various agencies to obtain initial and continued approval of all clinical trials. Oversee appropriate implementation and use of the eRegulatory system. Oversees regulatory data entry to sponsor EDC systems and responsible for ensuring accuracy of data entered and submitted for all assigned clinical trials.

Associate degree (A.A.) or equivalent from two-year college or technical school.

3-5 years related experience; or equivalent combination of education and experience.

In-depth knowledge of regulatory guidelines for clinical trials including FDA regulations and ICH guidelines.

GCP training certification preferred.