Clinical Research Professional, Regulatory Affairs, Start Up Coordinator

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 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 UCCC Start up Coordinator will be responsible for overseeing a study from initial interest through opening to accrual at UC.
• Work to support feasibility and scientific review processes.
• Completeinitial IRB submission.
• Assist in preparation of site adapted ICF according to local requirements.
• Collectand completeessential regulatory documentation for start-up.
• Coordinatecontract and budget submissions.
• Provideongoing status reports about studies in start-up process.
• Interactdaily with sponsors, CROs, and internal UC staff.
• Related, other duties as assigned.

• Bachelor's degree in related discipline or equivalent education/experience.
• 1-3 years of relevant experience, ideallyin an academic, clinical, or laboratory setting.

• 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.
• Experience in an academic or clinical setting in the area of clinical specialization.
• 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 approach to problem solving.
• Demonstrated knowledge or demonstrated related experiences to comprehend, interpret, and apply regulations and legislation regarding the protection of human subjects. These include regulations under federal policies, FDA, and other compliance agencies or directive.
• Working knowledge of UC Human Research Protections Program (HRPP/IRB) policies and Procedures.