Research - Laboratory/Non-Laboratory, Staff/Administrative
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 investigatorfocused 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 part time (0.5 FTE) position of Intermediate Associate Regulatory Analyst (MARA) collaborates with the IRBMED single IRB (sIRB) team to provide highly competent administrative and regulatory support for review and maintenance of IRB relationships associated with multi-site research. Specific duties include:
Review of eResearch applications associated with sIRB studies for oversight has been accepted or ceded and provide assistance to other IRBMED regulatory staff overseeing multi-site research applications
Assure that all appropriate information is entered into sIRB tracking systems (MiCORES) to assure regulatory compliance and facilitate billing
Act as a resource for IRBMED regulatory staff to address sIRB questions
Provide guidance to PIs/study teams related to the correct application workflows
Assist the IRB with budget development for accepting oversight and perform billing procedures as indicated
Assist with quality checks to assure regulatory compliance
Create agendas for weekly meetings to evaluate sIRB requests for accepting or ceding IRB oversight
Contribute to development of sIRB educational and guidance materials for the research community
3-5 years of related experience
Minimum of 3 years of experience in clinical research or research oversight
Ability to understand and scrutinize scientific documents, including clinical research protocols and grant applications
Knowledge of federal human subject protection regulations (45 CFR 46 and FDA 21 CFR 50, 56) as evidenced by experience and training
Demonstrated communication, organizational, critical thinking, interpersonal and teamoriented skills
Ability to work independently with minimal supervision
Ability to multi-task and prioritize daily work
Extremely proficient computer skills and strong writing abilities
Experience with multi-site research and single IRB relationships
Familiarity with University research policies and procedures, IRBs, and eResearch
Familiarity with electronic IRB application systems
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: 199303
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.