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.
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.
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 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.
This position reports to the IRBMED Director and provides oversight for the functional operations of the IRBMED Office regulatory review procedures and associated regulatory and operational requirements.
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*
Duties include, but are not limited to:
- Supporting the operations of the 6 convened boards comprising IRBMED by providing administrative and regulatory expertise
- Managing the daily administrative activities of the IRBMED Office to support efficient and compliant operations:
- Developing and implementing necessary procedures to assure compliant operations of the IRBMED
- Supporting IRBMED Office 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
- Identifying regulatory requirements to be included as part of educational programs for the IRBMED office, boards, and research community
- Meeting with principal investigators and study teams to provide guidance on regulatory matters
- Coordinating the hiring, training, evaluation, and professional development of IRBMED Office staff
- Meeting with the IRBMED Director on a regular basis to report on routine efforts, coordinate priorities, and to consider matters presenting additional complexity in their management or resolution
- Assisting the IRBMED Director 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
- Providing support for regulatory or accreditation site visits
- Fostering teamwork to proactively contribute to a productive and collegial work environment
- Maintaining a culture of quality service and compliance
- Representing the IRBMED office within the medical school and at designated meetings
- Serving as a professional role model and content expert to the IRBMED Office staff
- Conducting special projects as assigned
Required Qualifications*
- Educational experience generally associated with a Master's degree or equivalent years of work experience. Certification for IRB Professionals (CIP) desirable or attainment of certification within one year of eligibility
- At least 5 years' experience related to human research or research administration in a university setting
- 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
- Five or more years of experience in supervising the work of others; experience training and overseeing assigned work and an ability to motivate team members
- 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*
- Experience with FDA and other federal audits
- Experience in project management
- Knowledge of University of Michigan human protection systems including the eResearch application system
- Demonstrated experience in managing relationships in a complex environment
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.