Institutional Research Director jobs in Novi, MI

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

As a premier, research-intensive academic medical center, the University of Michigan Medical School is world renowned with over $800 million in research expenditures. The Medical School Office of Research proudly supports our internationally recognized researchers pursuing innovative science to improve the health and wellbeing of our patients and the citizens of Michigan and beyond. 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 University of Michigan Medical School is seeking an experienced Director to lead the Medical School's Institutional Review Board Medicine (IRBMED) team (IRBMED Director). The Director of the IRBMED (Institutional Review Boards Medicine) is responsible for the management and oversight of the IRBMED office and the six Institutional Review boards that share responsibility for the protection of the rights and welfare of human research participants and for the compliant review of research. A component of the University of Michigan's Human Research Protection Program (HRPP) and a unit of the Medical School Office of Research, IRBMED reviews research conducted at the Medical School, Michigan Medicine, and other locations and is charged with protecting the rights and welfare of human research participants. The IRBMED Director is responsible for monitoring compliance with federal and state regulations, university policies, and ethical principles (particularly those articulated in the Belmont Report).

The IRBMED Director reports to the Medical School Associate Dean for Research who is also appointed as the University of Michigan Associate Vice President for Research-Clinical and Human Subjects Research. Additionally, this position will report to the University of Michigan IRB Executive Director who holds a full appointment with the University of Michigan Office of Research. The IRBMED Director will have a joint appointment and joint reporting lines (50%/50% in both the Medical School Office of Research and University of Michigan Office of Research).

This position is eligible for the University of Michigan's Flexible First Work Policy. The selected candidate will be able to work with their manager to establish a flexible work location and potentially some variation to work schedule. A remote work schedule is possible with on-site work, as required.

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.

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*

To facilitate excellence in human research and the protection of research participants, the position will:

• Oversee daily operations of IRBMED to ensure review procedures meet regulatory compliance standards, provide appropriate participant protections, and are timely in association with achievement of goals; meet with the Executive Director IRBs on a regular basis to provide updates.
• Oversee daily management of the IRBMED Office, including human resource management (hiring, training, developing, mentoring, and terminating); financial management (budget forecast and expense management, recharge management, and overall fiscal stewardship); and business administration consistent with Michigan Medicine and university policies and procedures; support IRBMED Office Staff in their daily work; assure that IRBMED staffing is sufficient to meet volume requirements.
• Provide regulatory and policy guidance and support to the IRBMED co-chairs and board membership necessary to facilitate ethical, compliant, and efficient review of human subjects research under IRBMED jurisdiction.
• Identify the needs of the clinical research community to promote research and scholarship for faculty and trainees.
• Resolve matters of concern and report to designated leadership according to regulations and operating procedures.
• Provide oversight and assistance with the review, fact finding, and presentation of information to identified leadership in association with matters of noncompliance; administer weekly meetings with IRBMED co/vice chairs to review information and determine corrective actions; assure reporting to appropriate federal agencies and institutional officials.
• Address development of IRB efficiencies, strategy, and policy within IRBMED, in alignment with Michigan Medicine, Medical School, and in association with the HRPP; collaborate within the HRPP infrastructure to develop and maintain consolidated IRB SOPs and assure the Operations Manual (OM) is congruent; develop and report metrics associated with IRBMED review activities.
• Support efforts associated with identifying and implementing a new electronic regulatory management system.
• Collaborate with IRB leadership and strategic partners on the UM IRB strategic plan toward unifying review procedures and optimized electronic research application systems.
• Assure that IRBMED staff, boards, and the research community have sufficient and appropriate educational materials to support the review and conduct of human research.
• Assure readiness for audits from external entities including FDA, OHRP, and AAHRPP.
• Represent IRBMED on institutional committees and advise on matters related to human research policies and regulations.
• Respond to questions from the research community and external entities.
• Represent U-M research protections on a national scale.

Leadership Competencies:

• Collaborates to create a shared vision, effectively communicates the vision, and inspires stakeholders to build consensus.
• Collaborates and builds inclusive relationships with appropriate stakeholders and models respect, recognition, and collaboration.
• Creates value for a diverse community by fostering a climate of service excellence supporting a work climate that is inclusive and elicits a high level of team engagement.
• Leads innovation and change through the application of lean thinking philosophy, tools, and techniques to increase operational efficiencies.
• Coaches and develops others and provides professional development support. Develops talent with both the individual and organizational needs in mind.
• Develops a culture of accountability, provides the team with strategic direction, prioritization, and support to achieve results.
• Adapts oneself in a complex environment, adjusting as required and always engaging in self-reflection, continual learning, and growth.
• Acts with courage and confidence to encourage creative thinking, seize opportunities, demonstrate personal conviction, and convey an optimistic outlook.

Required Qualifications*

• An advanced degree in a relevant scientific, medical, or legal discipline.
• 5 or more years direct experience overseeing and supervising IRB functions for biomedical or health science research.
• Expert knowledge of federal, state, and local human research and other regulations, policies, and guidance and their direct application to the research environment.
• Leadership, management, and supervisory experience associated with large-scale offices and complex workflows.
• Experience developing and implementing policies and procedures.
• Excellent analytical and independent problem-solving skills, organizational, coordination and prioritization skills.
• Excellent verbal and written communication skills, computer skills, and experience with electronic IRB systems.
• Ability to produce detail-oriented and accurate documents, reports and announcements.

Desired Qualifications*

• Detailed working knowledge of AAHRPP accreditation standards and experience with FDA and other federal audits.
• Experience and working knowledge of developing content for electronic IRB application systems.
• Experience in project management.
• Demonstrated experience in managing relationships in a complex, matrixed environment..
• Experience in an academic research 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.