OPRN Multi-Site Regulatory & Compliance SpecialistRequisition ID2023-47847CategoryResearchOverviewThe OPRN Compliance and Regulatory Specialist will provide day to day oversight of all regulatory aspects of OPRN Multisite Investigator Initiated Studies (IIS); overseeing the IRB/regulatory and reliance processes to ensure compliance with all local policies and procedures as well as site-specific considerations. The position requires an in-depth, working knowledge of federal regulations including U.S. Food and Drug Administration (FDA), National Institute of Health (NIH), Department Health and Human Services (DHHS); International Conference on Harmonization Good Clinical Practices (ICH GCP), IRB and institutional policies, as well as an ability to discern critical pieces of information in study protocols and an in-depth knowledge 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.ResponsibilitiesEssential Job Functions:Supervises the overall regulatory process under the direction of Clinical Research Project Managers for OPRN Multi Site IIS projects; identifying areas of risk and assisting with developing processes to address deficiencies; creates new processes to improve efficiencies and/or respond to system changes.Responsible for communication with NCH IRB, study sites, and Data Coordinating Center, as appropriate, to create and maintain the Regulatory Essential Documents List and eTMF guide, creates and implements training materials for engaged study sites for IIS reliance regulatory process.Participates in site assessment visits in conjunction with Clinical Research Project Manager.Participates in internal and site-specific feasibility assessment discussions, identify protocol content which may conflict with federal and/or local requirements or practice or may cause challenge for site implementation.Reviews study protocols in order to facilitate accurate IRB submission, interaction with sponsors, management of the IRB and regulatory processes within the regulatory team both internally and externally via the iREX reliance system.Manages the development and implementation of clinical research education training in conjunction with the Clinical Research Project Manager for site continuing education and study regulatory integrity.Identifies additional training and Quality Improvement Program needs within study sites; makes recommendations to OPRN study leadership; implements