Western Michigan University Homer Stryker M.D. School of Medicine (WMed) is seeking an Institutional Review Board (IRB) Specialist. The IRB Specialist serves as an expert consultant to the WMed Institutional Review Board (IRB), the Chair and its members. The WMed IRB oversees the ethical conduct of research for the WMed research community and affiliated hospital systems and clinics. The IRB Specialist facilitates the review and approval process of research proposals using independent judgment in interpreting and applying relevant federal and state laws, regulations, policies and guidelines; evaluates protocol submissions to determine if proposed research is ethically acceptable and compliant with relevant regulations; instructs the IRB chair, members and researchers on the regulations and ethical principles essential to the review process, and provides training and advice.
BA/BS required; Masters or advanced degree preferred
A minimum of 5 years' experience in IRB administration is preferred. Experience in IRB administration in a clinical environment is strongly preferred.
Experience with making non-human research, exempt, and non-engagement determinations strongly preferred
Good working knowledge of Federal regulations, guidance, and practice standards for human research (21 CFR 50, 56, 213, 812; and 45 CFR 46) and other regulations (e.g. HIPPA) that impact the conduct and IRB review of research, with the ability to apply this knowledge across a diverse portfolio of research.
Demonstrated ability to utilize common software such as Word, Excel, PowerPoint, SharePoint; ability to learn new software as required and remain proficient in all programs necessary to perform duties of this position.
Experience with electronic IRB submission system preferred.
Certified IRB Professional (CIP) required within 1 year of eligibility
Coordination, evaluation, and processing of submission to the WMed IRB.
Conducts non-human research, exempt, and non-engagement determinations.
Conducts pre-review of submissions (initial, continuing review, modifications, unanticipated problems, deviations, etc.) to ensure all requirements have been fulfilled and that submissions are complete and accurate prior to assigning for review.
Coordination with external IRBs.
Conducts pre-review of requests to submit to an external IRB to ensure all requirements have been fulfilled and that necessary approvals and agreements are in place prior to submission to the external IRB.
Coordinates with other committees and offices to ensure that internal requirements are fulfilled and that information is shared with appropriate parties (e.g. COI, IBC, Sponsored Programs, and External IRB).
Evaluate ongoing reports and correspondence related to research under the oversight of external IRBs to identify and items that might require internal action or follow up.
Partner and maintain necessary documentation to support regulatory guidance for HRPP and IRB.
May serve as a voting member of the convened IRB and a designated Expedited Reviewer to review and approve non-exempt minimal risk research using expedited review procedures as well as not human subjects, research, and exempt determinations.
Utilize subject matter expertise to serve as a resource to IRB members, researchers and others on IRB topics.
Partner with other members of the HRPP and IRB in the development and refinement of SOPs, guidance documents, forms and checklists.
Assist with IRB and investigator audits and inspections as needed.
Availability to work occasional overtime on weekends or evenings to complete time sensitive projects.
Acquires knowledge for new technology and policy/procedure revisions.
About Western Michigan University Homer Stryker M.D. School of Medicine As one of the newer US medical schools, WMed is an exciting environment to pursue an academic career. The medical school is a collaboration of Western Michigan University and Kalamazoo's two teaching hospitals, Ascension Borgess Health and Bronson Healthcare. The medical school is a private 501(c)(3) nonprofit corporation supported by private gifts, clinical revenues, research activities, tuition, and endowment income. WMed is fully accredited by the Liaison Committee on Medical Education (LCME) and also by the Higher Learning Commission (HLC). The inaugural medical student class graduated in 2018 after completing an innovative, patient-centered four-year curriculum that prepares them to be exceptional clinicians, leaders, educators, advocates, and researchers of tomorrow. There are more than 200 residents and fellows in ten residencies and three fellowships accredited by the Accreditation Council for Graduate Medical Education (ACGME). WMed has Joint Accreditation for interprofessional continuing education, which incorporates accreditation by the Accreditation Council for Continuing Medical Education (ACCME). The School of Medicine Clinics are housed in a modern 60,000 square foot clinical building on the Oakland Drive Campus and are accredited by The Joint Commission with recognition by the National Committee for Quality Assurance (NCQA) as a Patient-Centered Medical Home. The 350,000 square foot educational building on the W.E. Upjohn M.D. Campus located in downtown Kalamazoo underwent a $78 million renovation and expansion project including two laboratory research floors and a state-of-the-art Simulation Center that is accredited by the Society for Simulation in Healthcare. The Innovation Center on the Parkview Campus is a life science, technology, and engineering incubator serving the earliest startups to maturing companies with laboratory, office and conference space, access to core scientific equipment and expertise, and a wide range of support services.
Kalamazoo is a wonderful and vibrant city, located midway between Chicago and Detroit. It is a short distance from Lake Michigan, and home to two nationally ranked institutions of higher learning, Western Michigan University and Kalamazoo College. Kalamazoo is known for its community focus and emphasis on access to quality education at all levels. The Kalamazoo Promise is a nationally renowned program in which graduates of Kalamazoo Public Schools receive free tuition to attend public and private colleges in Michigan. Kalamazoo and Michigan provide extensive entertainment and recreational activities, including opportunities to enjoy the outdoors, unique restaurants and shops, and a strong culture supporting the arts.
Western Michigan University Homer Stryker M.D. School of Medicine is an Equal Employment Opportunity/Affirmative Action employer of females, minorities, individuals with disabilities, and protected veterans, and actively strives to increase diversity within its community. We provide a drug- and tobacco-free workplace.