Senior Clinical Research Professional, UC Cancer Center, Regulatory Current UC employees must apply internally via SuccessFactors > Founded in 1819, the University of Cincinnati ranks among the nation's best urban public research universities. Home to over 50,000 students, 11,000 faculty and staff and 332,000 alumni, UC combines a Top 35 public research university with a physical setting The New York Times calls "the most ambitious campus design program in the country." With the launch of Next Lives Here, the Cincinnati Innovation District, a $100 million JobsOhio investment, nine straight years of record enrollment, global leadership in cooperative education, a dynamic academic health center and entry into the Big 12 Conference, UC's momentum has never been stronger. UC's annual budget tops $1.65 billion and its endowment totals $1.8 billion. Job Overview 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. The College of Medicine, Cancer Programs is looking for a Clinical Research Professional. This position will support the University's mission and commitment to excellence and diversity in our students, faculty, staff and all our activities. This position provides support and assistance for the University of Cincinnati Cancer Center. Duties focus on regulatory affairs. The UC Clinical Research Professional: Regulatory Affairs, Start up Coordinator will be responsible for overseeing a study from initial interest through opening to accrual at UC. Essential Functions Work to support feasibility and scientific review processes Completing initial IRB submission Assist in preparation of site adapted ICF according to local requirements Collecting and completing essential regulatory documentation for start-up Coordinating contract and budget submissions Providing ongoing status reports about studies in start-up process Interacting daily with sponsors, CROs, and internal UC staff Related, other duties as assigned Minimum Requirements Bachelor's degree in related discipline or equivalent education/experience; 1-3 years of relevant experience, ideally in an academic, clinical, or laboratory setting. Additional Qualifications Considered Knowledge of medical and pharmaceutical terminology and concepts, as well as theoretical knowledge and/or bachelor's degree and/or equivalent education and/or experience in a field related to biological sciences as needed to work in Regulatory Affairs. Excellent communication skills with sponsors, coworkers, and physicians. Experience working with FDA regulations, NCI policies and procedures, and Good Clinical Practice guidelines for the conduct of clinical research. Experience preparing various forms, documents, and reports, such as Investigational Drug Fact Sheet, New Study Applications, Renewal Applications, IND Applications, etc. Experience preparing, reviewing, and understanding clinical research protocols, and protocol amendments. Experience developing and maintaining record management systems. Strong administrative and organization skills, experience prioritizing assignments when faced with a heavy workload and competing deadlines. Experience creating Informed Consent Documents that comply with HRPP/UC IRB policies and procedures, FDA regulations, and sponsor requirements. Experience using standard word processing and data management software programs, including Word and Excel, in order to develop and prepare reports. Experience with editing, including summarizing information into concise and condense documents. Proven ability to determine sources of information and data and to analyze the data and information obtained, in order to create documents and to propose solutions to issues. Detail oriented, logical, and methodological