Regulatory Affairs Specialist
6 days ago
The University of Cincinnati is seeking a highly skilled Clinical Research Professional to join our team. As a key member of our research team, you will be responsible for overseeing the start-up process for clinical trials, ensuring compliance with regulatory requirements, and providing exceptional support to our researchers and sponsors.
Key Responsibilities- Oversee the start-up process for clinical trials, including feasibility and scientific review processes.
- Complete initial IRB submissions and assist in the preparation of site-adapted informed consent forms.
- Collect and complete essential regulatory documentation for start-up, including contract and budget submissions.
- Provide ongoing status reports about studies in the start-up process.
- Interact daily with sponsors, CROs, and internal UC staff to ensure seamless communication and collaboration.
- Bachelor's degree in a related field or equivalent experience.
- 1-3 years of relevant experience in an academic, clinical, or laboratory setting.
- Knowledge of medical and pharmaceutical terminology and concepts.
- 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 Sheets, 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.
- 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, to develop and prepare reports.
- Experience with editing, including summarizing information into concise and condensed documents.
- Proven ability to determine sources of information and data and to analyze the data and information obtained, in order to create documents and propose solutions to issues.
- Demonstrated knowledge or demonstrated related experiences to comprehend, interpret, and apply regulations and legislation regarding the protection of human subjects.
- Working knowledge of UC Human Research Protections Program (HRPP/IRB) policies and procedures.
- Sitting - Continuously
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