Human Research Compliance Associate

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Human Research Compliance Associate
The candidate will be responsible for providing regulatory and compliance advice on a day-to-day basis to the Institutional Review Boards (IRBs). Will be with respect to applicable federal, state, and local laws and regulations, and institutional policies relating to protection of human subjects in research conducted at or through University. Will also be responsible for providing this advice to University investigators, their research staffs, and other members of the broader University human subjects research community, including researchers at non-University sites relying on the review of the University IRBs. In cooperation with relevant staff and institutional officials (including Counsels for University, and the Assistant Dean for Human Research Protections), will work to interpret and apply all aspects of pertinent government regulations and institutional policies pertaining to human subjects research and related matters. Review applications submitted to the IRBs to identify deficiencies under federal and state laws and regulations, and institutional policies that must be corrected prior to IRB review. Determine that appropriate protocol- and application-specific documentation is submitted, e.g., requests for waiver of consent, waiver of HIPAA authorizations, formal communications from the FDA or commercial sponsors. Assist in the review of IRB action outcomes, including the IRB's minutes where required, and determine that regulatory, legal, and policy issues and their outcomes are documented appropriately. Attend weekly IRB meetings to provide regulatory expertise, monitor proceedings, and assist staff with regulatory documentation issues.

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