Clinical Research Regulatory Specialist I, College of Medicine, Internal Medicin

Current UC employees must apply internally via SuccessFactorsNext Lives at the University of Cincinnati Founded in 1819, the University of Cincinnati ranks among the nation’s best urban public research universities. Home to more than 53,600 students, 12,000 faculty and staff, and over 360,000 living alumni, UC, a Carnegie 1 institution, combines research prowess with a physical setting The New York Times has called “the most ambitious campus design program in the country." UC's momentum has never been stronger as the anchor of the Cincinnati Innovation District, the oldest cooperative education (co-op) program in the country with students earning $94 million annually through paid experiences, an academic health system, and as a member of the Big 12 Conference. The university contributes $10.6 billion in economic impact to the city and $22.7 billion to the state of Ohio. At UC, next is all of us. Learn more at . UC is a mission-driven organization where we are committed to student success and positively transforming the community through scholarship and service. We thrive on innovation, making an impact, and fostering an environment where staff and faculty are key contributors to UC’s success. Job Overview As one of the oldest medical schools in the country, the University of Cincinnati College of Medicine (COM) has a reputation for training best-in-class health care professionals and developing cutting-edge procedures and research that improves the health and clinical care of patients. In partnership with the UC Health academic healthcare system and Cincinnati Children’s Hospital Medical Center, College of Medicine’s faculty and providers are transforming the world of medicine every day. The Department of Internal Medicine is a top-tier department with world-renowned faculty and staff. With world-class research, teaching and medical practice opportunities, why not choose the University of Cincinnati College of Medicine? The Department of Internal Medicine is hiring a Clinical Research Regulatory Specialist I who will manage all regulatory operations on assigned research studies. This will include coordinating and providing administrative support for clinical research regulatory activities and initiatives including reviewing documents, applications, and reports and ensuring compliance with internal and external regulatory frameworks. This position serves as a liaison for designated research protocols, programs or units with internal and external stakeholders such as IRBs, industry sponsors, contracting offices, and regulatory agencies. They will apply skills to a broad range of different types of studies, navigate resources, and identify issues needing escalation. Position is primarily remote with some on-site requirements possible as needed. This position is not eligible for H-1B (or J-1) sponsorship. Essential Functions Prepares and submits protocol specific documentation to regulatory agencies and internal or external stakeholders including: research protocols, informed consent forms, or other similar documents necessary for research start-up or maintenance or close-out. Serve as liaison for questions/issues for designated research protocols and performs submissions to Institutional Review Boards (IRBs) including initial submissions, continuing reviews, amendments, reportable events, and/or closure. Address all regulatory issues involving research protocols; interpret, analyze and apply federal, state, and local regulations, along with University rules and regulations, to ensure ethical research practices are followed; report suspected or known instances of noncompliance with University or federal regulations. Maintains all regulatory documentation within existing systems (i.e., Complion) and secure document storage, including those that are complex in nature (e.g., procedural and interventional studies). Comprehends, interprets, and applies regulations and legislation regarding the protection of human subjects. These include regulations under federal policies, FDA, and other compliance agencies or directive. Assist with activities related to development and execution of research agreements relating to the conduct of research activities. Prepares for, coordinates, and actively participates in site visits; communicates effectively with sponsors and/or contract research organizations (CROs). Interacts with IRB and sponsor contacts with close supervision. Prepares and submits documentation to regulatory agencies with close supervision. Perform related duties based on departmental need. This job description can be changed at any time. Required Education Bachelor's Degree. Required Experience 1-2 years of relevant experience. Additional Qualifications Considered SOCRA or ACRP certification Experience with research and regulatory requirements. Knowledge of clinical research, human subject research ethics and IRB procedures. Thorough understanding of Good Clinical Practice guidelines, Code of Fede