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Clinical Research Program Coordinator - RI Perinatal OPRN Requisition ID 2024-48491 Category Research Overview The Clinical Research Intake Coordinator will work closely with the OPRN Team, Principal Investigators, Sponsors, Clinical Research Services and Sponsored Projects Office to provide consistency in the clinical research grants initiation process, regulatory, and administrative components required to ensure compliance for a clinical research project. This position assists with scientific and budgetary feasibility and patient enrollment viability for all clinical research projects. This position requires an understanding of federal regulations including U.S. Food and Drug Administration (FDA), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), International Conference on Harmonization Good Clinical Practices (ICHGCP), study protocols and IRB policy, as well as an understanding of the day to day clinical research process. 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. Responsibilities Completes intake of all new clinical research projects to assist in the process for scientific, financial and patient viability review. Works closely with the Principal Investigator and study staff in coordinating activities and follow up associated with determining the feasibility of potential new clinical research projects. Responds to documentation requests from industry sponsors, initiates data warehouse queries, and creates and maintains all regulatory aspects of a study binder, including review prior to monitor visits. Reviews study protocols in order to complete consent/assent documents and develop the initial IRB submission; submits protocol amendments; responds to contingencies and obtains final approval of documents from sponsor and IRB on behalf of the principal investigator. Serves as primary resource to provide guidance to investigators and research staff on federal regulations, good clinical practices and IRB policies and systems. Identifies protocol content which may conflict with federal and/or local requirements. Works with marketing and research staff to ensure study information is posted appropriately. Assists with quality improvement audits, including the administrative binder, subject research records, case report forms, and other study documents. Oversees document retrieval and archival process at study termination. All other duties as assigned. Qualifications KNOWLE