Research Regulatory Analyst III

Inspecting protocol files and subject binders. Implementing the UF Research Monitoring Program which includes planning, organizing, and conducting directed and random post-approval project inspections to ensure investigator compliance with relevant HHS and FDA regulations, institutional and IRB policies and guidelines for the protection of research participants. Monitoring the consent process for compliance with protocol specifications and human subjects’ protection regulations is a component of the Research Monitoring Program. Encouraging Institutional, IRB, and investigator compliance by identifying variances that occur when implementing research activities, proactively addressing these issues, and providing guidance in their resolution. Providing findings and feedback to research teams and the institution is integral to this initiative.

Review of IRB submissions (new submissions, modifications) to evaluate proposal content and compliance with Federal, and State regulations, and UF policies. Assisting investigators in preparing protocols for IRB review, including recommending changes and communicating outcome of review.

Coordinate with IRB pre-reviewers in the pre-review of research; identify and (resources permitting) help resolve issues in research relating to Federal Regulations, IRB policies, and other regulatory requirements or compliance needs.

Intra and inter office communication, including listserv to address researcher needs and inquiries about the IRB matters, including myIRB assistance, ICF and protocol assistance.

Coordinating the UF component of Human Research Protection Accreditation initiatives which includes gap analysis and benchmarking with accredited organizations, top academic research institutions, and governmental agencies. This activity may vary in the amount of time necessary to achieve the organizational goal depending on accreditation cycle.

Liaison with Investigators and their staff and affiliated research compliance personnel. Educating research teams one-on-one, in small groups and in formal classes on ethical guidelines and federal regulations pertaining to human subjects’ protection, Guidelines for Good Clinical Practice, and IRB/Institutional policies and procedures.

Reporting compliance issues that are discovered to the applicable IRB. Developing, maintaining, and revising IRB Policies and Procedures, forms, and guidance documents for compliance with applicable federal, state, and local laws and regulations.

Duties as assigned

Prior experience in human subjects research; human subject protection program/s or research coordinator experience.