IRB Manager - RI Scientific BrackeenRequisition ID2023-47419CategoryResearchOverviewThe IRB Manager, under the direction of the Human Research Protection Program (HRPP) Director, provides leadership, coordination, and advanced regulatory knowledge and experience for the Nationwide Children's Hospital (NCH) Institutional Review Board (IRB). The primary responsibility will be to manage the protocol review process, identify submission processing issues, and independently determine whether the components of the proposed research follow federal, state and local regulations, Nationwide Children's policies, and accreditation standards. This position supervises the NCH IRB staff positions.Why Nationwide Children's Hospital?The moment you walk through our doors, you feel it. When you meet our patient families, you believe it. And when you talk with anyone who works here, you want to be part of it. Welcome to Nationwide Children's Hospital, Where Passion Meets Purpose.Here, Diversity, Equity and Inclusion are integrated into our core values and practices. We are passionate about building, sustaining and evolving an inclusive and equitable environment. We are seeking individuals who live these values and want to share their experiences and efforts in support of our collective mission.We're 14,000 strong. And it takes every one of us to improve the lives of the kids we care for, and the kids around the world we'll never meet. Kids who live healthier, fuller lives because of the knowledge we share. We know it takes a Collaborative Culture to deliver on our promise to provide the very best, innovative care and to foster new discoveries, made possible by the most groundbreaking research. Anywhere.Ask anyone with a Nationwide Children's badge what they do for a living. They'll tell you it's More Than a Job. It's a calling. It's a chance to use and grow your talent to make an impact that truly matters. Because here, we exist simply to help children everywhere.Nationwide Children's Hospital. A Place to Be Proud.ResponsibilitiesHuman Subjects Protection: Compliance and OversightMaintains current knowledge of Office of Human Research Protections (OHRP) and Food and Drug Administration (FDA) regulations, guidance and standards, Institutional SOPs, State and Local Laws, as well as Association for the Accreditation of Human Research Protection Programs (AAHRPP) accreditation standards.IRB Operations:Manage the work of IRB Coordinators, recommend hiring or disciplinary actions, or provide coaching, training, and mentoring (including CIP certification), as assigned.Manage daily operations of the IRB Office, including:Review expedited submissions (0.3FTE)Delegation/assignment of tasksPrioritization of tasks, establishing work priorities and deadlinesDirect, supervise, and coordinate administrative and clerical functionsEnsure IRB Coordinators review assigned protocols for completeness, consistency, and compliance with federal and state regulations and institutional guidelinesProvide supervisory support for the IRB Convened Board(s) teamDirect the maintenance of updated member roster, meeting schedules, agenda preparation, submission review and processing, working with PIs to address concerns prior to the meeting, preparation of detailed minutes, record keeping, providing modifications to the PI, reviewing modifications, and maintaining recordsProvide advice, consultation, assistance, and dissemination of information to IRB board and staff as neededAddress issues/concerns raised by and with IRB staff in consultation with the HRPP DirectorProvide support, as needed, to the IRB chairs on federal regulations and institutional regulations involving research with human sub