Research Regulatory Analyst III

University of Florida - Gainesville, FL

Full-time - Mid Level

Gainesville, FL

Educational Services

About the position

The Regulatory Analyst III at the University of Florida is responsible for ensuring compliance with HHS and FDA regulations, as well as institutional and IRB policies related to research activities. This role involves conducting inspections, monitoring consent processes, and providing guidance to research teams to promote adherence to ethical guidelines and regulatory requirements. The analyst will also assist in the preparation of IRB submissions and coordinate accreditation initiatives, while educating research teams on compliance matters.

Responsibilities

• Inspect protocol files and subject binders.
• Implement the UF Research Monitoring Program, including planning and conducting inspections.
• Monitor the consent process for compliance with protocol specifications and human subjects' protection regulations.
• Encourage compliance by identifying variances in research activities and providing guidance for resolution.
• Provide findings and feedback to research teams and the institution.
• Review IRB submissions to evaluate compliance with regulations and policies.
• Assist investigators in preparing protocols for IRB review and recommend changes.
• Coordinate with IRB pre-reviewers to resolve compliance issues.
• Communicate with researchers regarding IRB matters and provide assistance with myIRB, ICF, and protocol.
• Coordinate the UF component of Human Research Protection Accreditation initiatives.
• Educate research teams on ethical guidelines and federal regulations regarding human subjects' protection.
• Report compliance issues to the applicable IRB.
• Develop and maintain IRB Policies and Procedures, forms, and guidance documents.

Requirements

• Master's degree in an appropriate area and one year of relevant experience; or a bachelor's degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience.
• Experience with FDA regulations.

Nice-to-haves

• Prior experience in human subjects research.
• Experience with human subject protection programs or as a research coordinator.

Benefits

• Salary commensurate with experience and expertise.