Hot Job of the Day
Tampa General Hospital is hiring a Clinical Research Regulatory Supervisor!
Clinical Research Regulatory Supervisor–(180000V4)
Under the direction of the Director of the Office of Clinical Research, the Clinical Research Regulatory Supervisor is responsible for development of regulatory processes and oversight and supervision of regulatory day to day operations. The purpose of this position is to develop and lead the research regulatory team supporting research sites for conducting clinical trials performed at Tampa General Hospital (TGH). The position will manage all aspects of study intake and feasibility assessment facilitation, start-up, modification submissions, continuous reporting, and study close-out; communicate with internal and external stakeholders; and any relevant regulatory agencies. This position will be responsible for managing credentials and training files for all study staff. This position is key in implementing organizational goals to lead the regulatory efforts of TGH and coordinate all aspects of implementing and conducting clinical research in accordance with Good Clinical Practices (GCP). Conduct regular monitoring of research study documentation. This position will perform administrative duties as needed and is responsible for performing job duties in accordance with the mission, vision and values of the Office of Clinical Research and Tampa General Hospital.
Bachelor’s degree in business or related field; master’s degree preferred. Three years supervisory experience and a minimum of five years of experience in the regulatory management of clinical trials. Direct experience with IRB submissions and procedures. Proficiency in using and implementing clinical research and regulatory IT systems. Knowledge of regulations established by the Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP), International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines, and the Health Insurance Portability & Accountability Act (HIPAA). RAC, CCRA or CCRP certifications preferred.
Primary Location: Tampa
Work Locations: TGH Main Campus1 Tampa General CircleTampa33606
Job: Clinical Research
Organization: TGH – Hospital
Shift: Day Job
Job Posting: May 22, 2018, 12:58:27 PM
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