Clinical Research Regulatory Specialist I, Department of Neurology & Rehabilitation Services, Stroke

Next 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. 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 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 doctors and faculty are transforming the world of medicine every day. The Department of Neurology & Rehabilitation 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? UC is one of the largest employers in the Cincinnati region, employing over 15,000 full-time and part-time faculty, staff and student workers. Founded in 1947, the UC Department of Neurology and Rehabilitation Medicine is revolutionizing medicine by connecting discovery and education to world-class care in neurological diseases. Our vision is to be the model organization that integrates neurologic clinical care, research and education. The University of Cincinnati, College of Medicine, Department of Neurology and Rehabilitation Medicine is seeking a full-time Clinical Research Regulatory Specialist I. This person coordinates and provides administrative support for clinical research regulatory activities and initiatives including reviewing documents, applications, and reports and ensuring compliance with internal and external regulatory frameworks. They also serve 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 their skills to a broad range of different types of studies, navigate resources, and identify issues needing escalation. The position can be considered a hybrid role. Weekly time spent on site is near University of Cincinnati main medical campus in Clifton, Ohio. 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 Trainings/Certifications N/A Required Experience 1-2 years of relevant experience Physical Requirements/Work Environment Sitting - Continuously Hearing, listening - Continuously Talking - Continuously Compensation and Benefits UC offers an exceptional benefits package designed to support your well-being, financial security, and work-life balance. (UC Benefits) Eligibility may vary by position and FTE status. Highlights include: Comprehensive Tuition Remission UC provides tuition remission for you and your eligible dependents, covering tuition costs for nearly all undergraduate and graduate programs offered by the university. Robust Retirement Plans As a UC employee, you won't contribute to Social Security (except Medicare). Instead, you'll choose between state pension plans (OPERS, STRS) or an Alternative Retirement Plan (ARP), with UC contributing 14-18% of your salary based on position. Real Work-Life Balance UC prioritizes work-life balance with a generous time-off policy, including: Vacation and sick time 11 paid holidays and additional end-of-year paid time off (Winter Season Days) 6 weeks of paid parental leave for new parents Additional Benefits Include: Competitive salary based on experience Comprehensive health coverage (medical, dental, vision, prescription) Flexible spending accounts & wellness programs Professional development & mentorship opportunities UC is an E-Verify employer. If hired into this position, you will be required to provide satisfactory proof of employment eligibility by providing acceptable, original forms of identification for employment verification via the Federal I-9 employment verification process. Equal Opportunity Employer. Building a workplace where all qualified applicants will receive consideration for employment, including Individuals with Disabilities and Protected Veterans.

REQ: 104384

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