The University of Cincinnati is a premier, public, urban research university; ranked as one of America's top 26 public research universities by the National Science Foundation. U.S. News has ranked UC in the Top Tier of America's Best Colleges. The Chronicle of Higher Education calls UC a “research heavyweight”. Forbes, Delta Sky and Travel + Leisure magazines have named UC one of the most beautiful campuses. #HottestCollegeInAmerica
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, Department of Psychiatry and Behavioral Neuroscience is looking for a Senior Research Compliance Specialist. This position will support the University's mission and commitment to excellence and diversity in our students, faculty, staff and all our activities.
Essential Function Under general supervision from a designated administrator, serve as the main point of contact to facilitate action on research protocols/studies. Provide assistance and advice to assist Review Board/Committee decisions. Translate Board/Committee decisions and processes to maintain continuity and timely communications. Monitor protocols to insure regulatory compliance.
Serve as liaison for designated research protocols/ studies; perform initial/ongoing research protocol reviews and provide advice to the Board/Committee; perform protocol audits as required.
Use independent judgment to: interpret, analyze and apply federal, state and local regulations, along with University rules and regulations, to insure that ethical research practices are followed; to report suspected or known instances of noncompliance with University or federal regulations.
Attend Board/Committee meetings to review and discuss studies to insure compliance with federal, state, local regulations, and University policies & procedures.
Act as a resource for Board/Committee members regarding regulations during research protocol review. Resolve all issues involving research protocols.
Coordinate information to meet protocol-reporting requirements.
Resolve complex issues involving research protocols including direct communication with investigators and research staff.
Interact with investigators, faculty, students and administration of all levels.
May conduct on-site audits.
Conduct audits of internal records and processes.
May serve as full member on review board/committee.
Perform related duties based on departmental need.
Certified Clinical Research Professionals (CCRP) is required.
Strong IRB regulatory & compliance knowledge is required.
Bachelor's degree with three (3) years' experience; -OR- Associate's degree with five (5) years' experience; -OR- seven (7) years' experience.
2-5 years of directly relevant experience, preferably in an academic or clinical setting.
Exceptional organizational skills with attention to detail and accuracy, and excellent oral and written communication skills required. Significant computer proficiency.
Expert knowledge of related scientific and clinical terminology.
The University of Cincinnati, as a multi-national and culturally diverse university, is committed to providing an inclusive, equitable and diverse place of learning and employment. As part of a complete job application you will be asked to include a Contribution to Diversity and Inclusion statement.
The University of Cincinnati is an Affirmative Action / Equal Opportunity Employer / M / F / Veteran / Disabled.
The University of Cincinnati is a smoke-free environment.