Mission Statement

Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.

Responsibilities*

• Provide oversight for regulatory review procedures and operational requirements of the IRBMED Office and the convened boards.
• Manage daily administrative activities, including: developing and implementing office procedures to assure compliant operations; supporting staff to address workflows and efficiencies; overseeing operational metrics associated with review of IRB application materials; leading and/or attending meetings to enhance business decisions related to the quality and efficiency of the regulatory review process; developing and maintaining written documentation related to daily operations and workflows; and advising principal investigators and study teams on regulatory matters.
• Coordinate hiring, training, evaluation, and professional development of staff.
• Assist with oversight of programmatic/system initiatives and execution of strategies to enhance and fulfill the requirements of the HRPP, such as FDA inspections of IRBMED and AAHRPP accreditation.
• Represent the IRBMED office within the medical school and at designated meetings.
• Supervises 22 Research Compliance Specialists.
• Primarily works remotely from home in same Bureau of Labor Statistics Area as worksite address listed.

Required Qualifications*

• Requires Master’s degree in Clinical Research Administration, Pharmaceutical Sciences or closely related field
• 8 years of clinical research regulatory compliance experience in a medical school IRB, which includes: managing, assessing, and recommending changes to SOPs, workflows, and policy level documents; leading projects that involve multi-disciplinary teams; supervising and training staff, including utilizing metrics and key performance indicators for continuous improvement; applying federal human subject protection regulations under 45 CFR 46 and 164 and ICH-GCP, and FDA regulations for drugs, biologics, and device studies under 21 CFR 50, 56, 312 and 812; supporting IRB membership management, Board conduct and meetings, and advising IRB members in support of regulatory review; and using and developing improvements for custom electronic IRB systems.

Background Screening

Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.

Application Deadline

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.

Vaccine Requirements

COVID-19 vaccinations are required for all students, faculty and staff working in the following areas: Michigan Medicine including the Medical School, Dental School, University Health Service or the Mary A. Rackham Institute. This includes those working remotely and temporary workers. More information on this new policy is available on the U-M Health Response.

U-M EEO/AA Statement

The University of Michigan is an equal opportunity/affirmative action employer.