Primary Purpose: Performs a comprehensive regulatory process to ensure that all clinical research studies conducted on human subjects and/or human derived materials comply with federal, state and institutional regulations and policies.
Study startup process.
Prepares Institutional Review Board (IRB) submissions from sponsor-generated clinical trials and investigator-initiated protocols (federally and foundation-funded) including all required regulatory documents.
Drafts research subject informed consent forms and informed consent comprehension tests in compliance with IRB policies and procedures.
Maintains regulatory documents throughout the course of the study.
Guides principal investigators (PIs) and study coordinators in drafting advertisements for studies in compliance with regulations governing advertisements.
Continuously provides study-specific IRB/sponsor correspondence to PI and assigned study staff.
Prepares Investigational New Drug applications and follows through with required updates.
Conducts internal audits of regulatory documents for active studies to ensure that they adhere to federal, state, and local regulations, including but not limited to reviewing informed consents and recruiting materials in compliance with written Standard Operating Procedures.
Ensures regulatory staff, including research assistants and fellows, complete training required by affiliated institutions.
Responsible for coordinating reviews for a portion of the monitoring visits.
Perform other duties as assigned.
Educational Requirements: Associate's Degree in a related discipline plus 2 years of relevant experience, or a Bachelor's Degree, or 6 years of relevant experience. Regulatory-related work experience a plus.
Skills and Knowledge: Excellent written and verbal communication skills. Familiarity with research design. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
UC Health brings together the region’s top clinicians and researchers to provide world-class care to our community. From our flagship University Hospital to our state-of-the-art West Chester Hospital, UC Health delivers the absolute best in treatment and care. Continually recognized for excellence and backed by the academic strength of the University of Cincinnati, one of the nation’s top 25 publi...c research universities, UC Health is revolutionizing how discovery-driven care is delivered. It’s all part of UC Health’s mission to provide the highest quality and most compassionate healthcare through cutting edge clinical services, teaching, innovation and research across medical specialties. UC Health is an equal opportunity employer committed to a diverse and inclusive work environment.