How to Apply

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.

Job Summary

The primary mission of the University of Michigan Medical School Office of Research is to foster an environment of innovation and efficiency that serves the Medical School research community and supports biomedical science from insight to impact. To that end, our team is constantly striving to enhance the research enterprise, including maintaining an investigator-focused infrastructure, facilitating and diversifying investigators' avenues for funding, and streamlining research processes.

The UMMS Office of Research has numerous reporting units and programs such as the Michigan Institute for Clinical & Health Research (MICHR), the Clinical Research Calendar Review & Analysis Office (CRAO), the Fast Forward Medical Innovation, the Biomedical Research Core Facilities (BRCF), the Institutional Review Board (IRBMED), and the Medical School Grant Services & Analysis Office. Together, these teams provide the necessary support to position our researchers for success.

The mission of the Institutional Review Board of the Medical School (IRBMED) is to protect the rights and welfare of participants in clinical trials and other human subjects research studies by careful review and monitoring of research in accordance with applicable laws, regulations, and University policies. The IRBMED assists investigators with the design and conduct of research projects to minimize risk to human participants, provides guidance to the University and its researchers on ethical and procedural issues related to the use of human participants in research, and facilitates compliance with governmental and University policies pertaining to human subjects research. To perform its review, approval, and monitoring functions, the IRBMED is composed of six (6) review boards, each of which complies with applicable regulations concerning membership and conduct. The IRBMED oversees the protection of human participants in research conducted at Michigan Medicine which includes the University of Michigan Medical School and the UM Health System (UMHS) as well as research conducted off-site by faculty and staff as University employees or in connection with their University appointments. The IRBMED also reviews FDA-regulated research or medical intervention research conducted by faculty and staff from other U-M units including Dentistry, and the campuses of U-M Ann Arbor, Flint and Dearborn. IRBMED serves as IRB of Record for multi-site research or for individual investigators via use of IRB Authorization Agreements, including the nationally recognized SMART IRB agreement.

The IRBMED is firmly committed to advancing inclusion, diversity, equity, accessibility, and belonging, which are core to the culture and values of the Medical School Office of Research. Our community supports recruiting and cultivating a diverse workforce as a reflection of our commitment to serve the diverse people of Michigan and the world. We strive to create a work culture where each team member feels respected, valued, and safe.

The position of Senior Associate Regulatory Analyst (SARA) is responsible for the highly competent review of human subjects research applications submitted to IRBMED. Applicants for this position are expected to have experience with the conduct of clinical research, especially studies utilizing FDA-regualted drugs and devices.

Individuals qualifying for the SARA role would function without mentorship and with substantial autonomy in conducting IRB application reviews. Additionally, SARAs may provide functional oversight of a regulatory team within the IRBMED Office and are required to have a minimum of 5 years of relevant clinical research experience.
Process and clear contingencies following IRB review. Communicate outcomes of IRBMED decisions to study teams.
Utilize electronic IRB application software for all review activities.
Support special initiatives, including policy/procedure analysis and development, development of internal guidance documents for review staff, corrective actions for compliance concerns, and educations activities, etc.
Collaborate with and back-up co-workers, including, for example, protocol review and follow-up, board management, education, compliance, and other IRBMED unit activities.
Conduct additional related responsibilities as assigned by supervisor, including support of full board meetings as indicated, support of single IRB activities, and special projects.
Engage in professional development activities, including, for example, attendance and participation at regional and national meetings, professional IRB training and certification, and review of regulatory materials related to human participant protection.

Required Qualifications*

Educational experience generally associated with a Bachelor's degree or equivalent years of work experience.
Certification for IRB Professionals (CIP) desirable or attainment of certification within one year of eligibility
A strong clinical research background with a minimum of 5+ years of experience in human subjects research
A strong understanding and ability to apply federal regulations and agency guidelines, nationally accepted standards, and typical University contracts and agreements relating to IRB functions and participant protections
A strong understanding of clinical research workflows and external sponsor requirements
A strong commitment to the ethical principles underlying the rights and welfare of research participants
Ability to use astute judgement, think strategically and analyze logically, cogently, and persuasively present summaries and recommendations
Excellent oral and written communication skills
Effective management and interpersonal skills
Ability to manage sensitive and/or confidential data
Ability to work effectively both independently and as a member of a team

Desired Qualifications*

Knowledge of University of Michigan human protection systems including the eResearch application system
Experience with FDA and other federal audits
Experience in project management
Demonstrated experience in managing relationships in a complex environment

Modes of Work

Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes.

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.

U-M EEO/AA Statement

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