JOB SUMMARY

Under the supervision of the Research Regulatory Supervisor, completes and maintains regulatory documents for clinical research projects to ensure compliance with the study protocol, established institutional policies and procedures, applicable regulations and Good Clinical Practice (GCP) Guidelines. This position maintains documentation of the qualifications of the research team, provides research financial support and provides knowledge and support regarding clinical research regulatory matters. Responsible for performing job duties in accordance with mission, vision and values of Tampa General Hospital (TGH).

• Associate’s degree in business, scientific or health related field or other related field required, bachelor's degree preferred; two years of clinical research regulatory or related experience, one year if bachelor’s degree.
• 5 years of clinical research experience in lieu of a degree.
• Proficient in Microsoft Office as well as analytical and reporting tools such as spreadsheet and database applications.
• Experience in clinical research protocols including human subjects' applications and informed consent documents as well as experience with clinical research and regulatory IT systems preferred.
• Knowledge clinical research regulations that govern research established by regulatory agencies preferred.