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Principal Associate Regulatory Analyst
1 month ago
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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.
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.
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*
This position is critical to support the operations and productivity of IRBMED. The individual in this role oversees and works alongside the Expedited Team under the direction of the Assistant Director, IRBMED. This includes review, management, coordination, and promotion of human research at U-M. This position is expected to work under minimal supervision to direct the operations of the Expedited Team, through directing, analyzing, daily monitoring of the submission volumes, coordinating, and evaluating the Expedited Team operations within IRBMED. This includes developing and implementing training plans for the Expedited Team. This position is expected to establish team goals/objectives and reviews and approves standards that help achieve those goals/objectives. This role also advises the Expedited Team and research study teams on IRB application preparation, regulatory considerations, addresses concerns, and works to address these issues in a timely manner satisfactory to the IRB. The individual participates in other meetings as determined by the Directors (Director and Assistant Directors). The individual in this role serves as a technical/subject matter expert to the IRBMED office. The role supports special initiatives, including policy/procedure analysis and development, development of internal guidance documents for regulatory staff, and educational activities. This role is critical to maintaining the high-volume throughput expectations, especially for expedited reviews. It is strongly preferred that this role is filled by a candidate with an advanced level of clinical research experience to facilitate the timely and accurate review of clinical research applications.
Required Qualifications*
Bachelor?s degree or equivalent in education and experience.
Expert experience (8+ years) in an IRB, clinical research, or research regulatory affairs required.
Ability to understand and scrutinize scientific documents, including protocols, grants, etc.
Ability to direct, analyze, coordinate, and evaluate operations of the team and individual staff
Plan improvements or establish internal controls to assure effective and efficient operations
Demonstrated strong communication, organizational and interpersonal skills.
Ability to work independently but also within a team structure.
Strong knowledge of federal human subject protection regulations (45 CFR 46 and 21 CFR 50, 56, 312, and 812) as evidenced by experience and training, and professional IRB certification or the intent to obtain professional certification within a reasonable period is preferred.
Ability to multi-task and prioritize daily work.
Ability to engage and motivate team members
Proficiency in Microsoft Word, Excel, and PowerPoint.
Strong familiarity with electronic applications software (eResearch).
Strong familiarity with IRB procedures and processes.
Desired Qualifications*
Master's or higher level degree
Prior supervisory experience
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 maybegin as early as the eighth day after posting.Thisopening 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.
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