Research - Laboratory/Non-Laboratory, Staff/Administrative
A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.
This position is in the Health Sciences and Behaviorial Sciences Institutional Review Board (IRB-HSBS), a unit of the Human Research Protection Program (HRPP) within the U-M Office of Research (UMOR). IRB-HSBS is responsible for protecting the rights and welfare of human subjects participating in research conducted by faculty, staff and students affiliated with the University of Michigan – Ann Arbor Campus. The Associate Research Compliance Specialist will be responsible for conducting administrative and regulatory reviews of applications for research with human subjects submitted to the IRB- HSBS for assigned schools and colleges and will serve as the IRB liaison with those units. The successful candidate will also assist with processing reliance agreements. This position reports to the IRB-HSBS Director.
Administrative and Regulatory Review
Perform detailed administrative and regulatory review of applications for research with human subjects submitted to the IRB-HSBS via the eResearch Regulatory Management system.
Assess study protocols and accompanying documentation for completeness and clarity as well as for compliance with applicable regulations, guidelines and policies.
Contact principal investigators to resolve inconsistencies and/or clarify information prior to IRB-HSBS review.
Respond to questions from investigators about the IRB application process and human subject protection regulations.
Prepare regulatory checklists and assign applications to reviewers.
Record IRB-HSBS decisions in eResearch and communicate regulatory determinations to principal investigators.
May also include support for the convened IRB-HSBS boards, including the Flint panel, such as agenda preparation and dissemination, note taking at board meetings, meeting set up, and other activities.
Participate in educational activities for the research community, including “IRB-on-the-Road”.May include travel to Flint and Dearborn campuses.
Special projects and other duties as assigned
Assist with reliance agreements.
Participate in IRB application redesign project
Bachelor’s degree in health or behavioral science field or the equivalent combination of education and experience.
One to three years of human subjects research and/or Institutional Review Board (IRB) experience as well as knowledge of federal human subject protection regulations (45 CFR 46) or other compliance areas.
Detailed-oriented individual who is able to prioritize multiple, time-sensitive tasks.
Excellent communication skills.
Proficient with Word, Excel, and PowerPoint.
Familiarity with the UM eResearch regulatory management system.
This is a part time, one-year, term-limited position working 25-30 hours per week.
The University of Michigan conducts background checks on all job candidates upon acceptance of a contingent offer and may use a third party administrator to conduct background checks. Background checks are performed in compliance with the Fair Credit Reporting Act.
Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.
The University of Michigan is an equal opportunity/affirmative action employer.
Internal Number: 180995
About University of Michigan - Ann Arbor
A great university is made so by its faculty and staff, and Michigan is recognized as one of the best universities to work for in the country. The Michigan culture is known for engaging faculty and staff in all facets of the university to create a workplace that is vibrant and stimulating.For two consecutive years, the Chronicle of Higher Education has placed U-M in its "Great Colleges to Work For" survey. In particular, the university earns high marks for strong relations between faculty and administrators, a collaborative system of governance, strong pay and benefits, and a healthy work/life balance.