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.
Qualifications: EDUCATION: Bachelor's degree from an accredited college or university in a discipline related to business, medicine, public health, biomedical, life science or basic science. An equivalent combination of education and experience may be accepted. EXPERIENCE: Requires 2 or more years of experience in a human participant research related job function. Basic monitoring or audit experience, and biomedical or pharmaceutical research experience preferred. KNOWLEDGE, SKILLS AND ABILTIES:Ability to manage a comprehensive monitoring program. Ability to work independently with minimal supervision.Ability to analyze and articulate complex issues, including scientific and ethical issues. Ability to communicate effectively with researchers and colleagues, verbally and in writing.Knowledge of research regulations as they pertain to the conduct of human participant researchSkill in the use of computers and software such as Microsoft Office, Microsoft Outlook and institutional specific software.Ability to engage researchers and colleagues in a respectful manner.Ability to maintain privacy and confidentiality as they pertain to research and monitoring activity. WORKING CONDITIONSThis position is stationed within an office setting but will require local travel within the University and its affiliates to conduct the monitoring and audit visits.
Founded in 1868, Wayne State University is a nationally recognized metropolitan research institution offering more than 400 academic programs through 13 schools and colleges to nearly 32,000 students. Wayne State?s main campus in Midtown Detroit comprises 100 buildings over nearly 200 acres; its five extension centers offer higher education to people throughout Southeast Michigan. Wayne State is dedicated to preparing students to excel by combining the academic excellence of a major research university with the practical experience of an institution that by its history, location and diversity represents a microcosm of the world we live in. Reflecting its location and the excellent international reputation of its graduate schools, particularly in the sciences, Wayne State boasts the most diverse student body among Michigan?s public universities. Its students represent 49 U.S. states and more than 60 countries.