Wayne State University’s Division of Research is looking for a Research Compliance Monitor

Essential Functions

Conduct independent post-approval monitoring visits of human participant research protocols, review protocol regulatory documents, informed consent process and data collection. Generate and update research protocol monitoring lists. Coordinate and schedule post approval monitoring visits and, as needed, follow-up visits.            

Maintain post approval monitoring report files, communicate findings and deficiencies directly to the Principal Investigator, Human Research Protection Program Administration and Institutional Review Boards when appropriate.               

Conduct audit activities to identify adverse events and protocol violations and direct to committee Chair, individual Institutional Review Board, institutional officials and/or regulatory agencies as appropriate. Provide procedural guidance to investigators when adverse events or violations are minor, to ensure policy and regulatory compliance are maintained. Conduct For-Cause Audits as requested by the Institutional Review Board Committee or Human Research Protection Program Administration. Conduct For-Cause Audit of human participant research protocols, review protocol regulatory documents, informed consent process and data collection. Communicate For-Cause Audit findings and deficiencies directly to the Principal Investigator, Human Research Protection Program administration and Institutional Review Boards when appropriate.  

Maintain and update post approval monitoring policies and procedures. Develop and provide post approval monitoring education sessions for researchers.

Engage with university and affiliate research departments to ensure compliance with federal regulations and institutional policies. When appropriate, in instances concerning research grants, the Administrator will work with the Sponsored Programs Administration to verify concurrence with the grant proposal.

Perform other related duties as assigned.