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.
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.
This position is critical to support the operations and productivity of IRBMED. The individual in this role conducts complex and comprehensive regulatory and ethical reviews of expedited and full board IRB submissions leading issuance of IRB approval. IRB review of human research is mandatory per federal, state, and institutional requirements and is critical in maintaining a compliant research program at the university. This role also advises research study teams on IRB application preparation, regulatory considerations, addresses concerns, and works with research teams to address these issues in a timely manner satisfactory to the IRB. The individual attends IRBMED Board meetings to present full board reviews and participates in other meetings as determined by the Director. The role supports special initiatives, including policy/procedure analysis and development, development of internal guidance documents for review staff, investigations into noncompliance matters and associated corrective actions, 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.
Master’s Degree in science or relevant discipline required.
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.
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) as evidenced by experience and training, and professional IRB certification or the intent to obtain professional certification within a reasonable period is preferred. Working knowledge of FDA regulations.
Ability to multi-task and prioritize daily work.
Proficiency in Word.
Strong familiarity with electronic applications software (eResearch).
Strong familiarity with IRB procedures and processes.
Direct experience with provision of clinical care strongly desired
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.
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.
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.
The University of Michigan is an equal opportunity/affirmative action employer.
Internal Number: 189450
About University of Michigan - Ann Arbor
A great university is made so by its faculty and staff, and Michigan is recognized as one of the best universities to work for in the country. The Michigan culture is known for engaging faculty and staff in all facets of the university to create a workplace that is vibrant and stimulating.For two consecutive years, the Chronicle of Higher Education has placed U-M in its "Great Colleges to Work For" survey. In particular, the university earns high marks for strong relations between faculty and administrators, a collaborative system of governance, strong pay and benefits, and a healthy work/life balance.