IRB Research Compliance Manager
Position Number: 00007627
Primary Function of Organization Unit: Sponsored Programs facilitates the preparation and submission of proposals to all external sponsors. They negotiate, execute and administer contractual issues on all sponsored funding agreements from Federal, State and local governments as well as commercial industry sponsors. and the administration of externally and internally funded sponsored projects. The office also prepares, negotiates and administers all subawards and subcontracts, providing sponsored funds to entities providing scientific collaboration on the sponsored projects. Sponsored projects support all three Land Grant University missions of NC State, Research, Instruction and Extension.
Essential Job Duties: The Regulatory Compliance Manager manages all aspects of the Institutional Review Board (IRB), and holds the position of "Institutional Review Board (IRB) Administrator," a federally regulated position holding specific authority to manage institutional assurances with Office of Human Research Protection, US Department of Health and Human Services. Duties include, but are not limited to: * Facilitate compliance with human subject protection regulations by providing administrative leadership and service to the University research community, including the following: - Responsible for all aspects of daily IRB functioning; - Act as liaison between the IRB and University personnel, helping University researchers understand and fulfill federal requirements; - Perform initial IRB submission review and decide the level of review, as mandated by federal regulations, for each submission. * Authorized to review and administratively approve any research that meets the federal criteria for exemption. * Manage the IRB review process for expedited and full board review, including acting as liaison between the IRB and researchers. This involves providing IRB protocols to reviewers with appropriate expertise and ability to review the research, performing preliminary reviews to highlight important aspects for IRB reviewers to consider, provide guidance to reviewers as needed, tracking submissions and follow up on delinquent reviews, and managing post-review correspondence with researchers. * Arrange and coordinate monthly IRB committee meetings including membership management, coordinating meeting agendas, preparing and maintaining meeting minutes, ensuring that quorum is maintained, instructing committee members and researchers regarding the federally mandated criteria for approval of research, and managing post-review correspondence with researchers. * Receive and process continuing review requests and study modification/addendum requests. * Maintain documentation to finalize approvals, synthesize final IRB submission files, send correspondence, * Track and document IRB submissions, findings and status so as to address audit concerns and provide notification of expiring protocols. * Assist with and IRB policy and procedure development as needed. * Maintain current knowledge of federal and state regulations regarding human subjects protection.
Minimum Education/Experience: Master's degree or a Bachelor's Degree plus significant relevant experience with/knowledge of the Institutional Review Board for the Protection of Human Subjects in Research (IRB) as well as policies regarding research/academic integrity.
Department Required Skills: Excellent oral and written communication skills.
Preferred Experience, Skills, Training/Education: Experience working with or in an IRB in the biomedical field and NIH preferred.
Necessary Licenses and Certifications: N/A
AA/EOE: NC State University is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, gender identity, age, sexual orientation, genetic information, status as an individual with a disability, or status as a protected veteran.
Individuals with disabilities requiring disability-related accommodations in the application and interview process, please call 919-515-3148. Final candidates are subject to criminal & sex offender background checks. Some vacancies also require credit or motor vehicle checks. If highest degree is from an institution outside of the U.S., final candidates are required to have their degree verified at "www.wes.org":http//wes.org. Degree must be obtained prior to start date.
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