Auditing protocol files and subject binders, 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, in addition to implementing Investigator self-audits.    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.  This is for all UF IRBs (-01 HSC/VAMC, -02 Social Behavioral)
Quantity of studies to be audited should be reassessed quarterly by Director of Research Operations and Associate Director of IRBs to determine if expectations need to be increased or decreased (e.g. if for cause audits or other special assignments temporarily impact availability). 

Committee support – regulatory and annotating agenda.

Assessing and improving IRB and investigator compliance with federal regulations, state laws, and institutional policies through inspection of IRB files, monitoring of IRB meetings, review of OHRP Determination and FDA Warning Letters, and discussion with IRB Executive Committee.   Reviewing initial exempt, expedited, and full board IRB submissions (initial, continuing review, and interim reports) for compliance with applicable requirements. Ensuring IRB/ exempt determinations comply with the federal, state, and local requirements.

Coordinating the UF component of Human Research Protection Accreditation initiatives. This regularly includes minutes audits and annual accreditation reports; gap analysis and benchmarking with accredited organizations, top academic research institutions, and governmental agencies is also expected although 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.

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.

Bachelor's degree in an appropriate area of specialization, or college work in science and /or research with two years of appropriate experience, familiarity with medical terminology.  Strongly prefer individuals with prior experience working as a research coordinator engaged in human research.  Prefer individuals with (a) prior experience in human subjects research or research compliance; (b) working knowledge of human research protection related regulations, laws, and institutional policies; (c) ability to act as liaison and to use negotiation skills to assist investigators with processing their protocols.  The selected candidate must possess excellent written and oral communication skills.