THEOFFICE OF HUMANRESEARCHETHICS IS HIRINGFOR 2 IRBANALYSTS (00057143 & 00052810). BY APPLYINGFORTHISPOSTING, YOUWILL BE CONSIDEREDFORBOTH.
The IRB Analyst serves as expert consultant to the IRBs, their Chairs and their members. The IRBs oversee the ethical conduct of research for the entire UNC research community and Rex Hospital, including student-led research, collaborative international research, and complicated FDA-regulated clinical research. The IRB Analyst facilitates the review and approval process, using independent judgment in interpreting and applying relevant federal and state laws, regulations, policies and guidelines; evaluates protocol submissions to determine if proposed research is ethically acceptable and compliant with relevant regulations; instructs IRB chairs, members and researchers on the regulations and ethical principles essential to the review process; and provides training and advice to faculty, staff, and student researchers on institutional policies and the regulations and the preparation of application and consent forms, including use of the IRBIS online submission system. In addition, the IRB Analyst interacts directly with investigators, study staff, and relevant University offices (e.g. Office of University Council, Office of Sponsored Research, Office of Clinical Trials, Conflict of Interest Office) as needed.
Education and Experience:
Bachelor’s degree in a discipline related to the field assigned and one year of related training or experience; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.
Familiarity with all applicable federal regulations (21 CFR 50, 56 and 45 CFR 46). Exceptional oral and written communication skills. Understanding of the ethical considerations involved in human subject research. Comprehension of/facility with multiple computer database systems. Ability to perform multiple duties simultaneously. Ability to educate investigators and research Analysts regarding human subject regulations.
Understanding of the ethical considerations involved in human subject research
Familiarity with all applicable federal regulations (45 CFR 46 and 21 CFR 50 & 56), State and University policies, and the ability to identify and resolve any conflicting interpretation of those regulations.
Comprehension of and facility with computer database systems
Attention to detail
Ability to perform multiple duties simultaneously and to manage occasional increased workload volumes
Ability to prioritize and process IRB submissions in an expeditious manner
Independent decision-making while exercising good judgment
Exceptional oral and written communication skills; frequent telephone conversations with research faculty and staff, and University administrators
Ability to educate investigators and research coordinators regarding federal regulations and University policies governing research
Prior experience in research, research administration, and/or regulatory affairs is highly desirable, with preference given to those candidates possessing IRB experience. Knowledge of complex medical concepts and terminology is important. Reading knowledge of Spanish/other foreign languages is a desirable plus. Certified IRB Professional (CIP) preferred.
The University of North Carolina at Chapel Hill is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender, gender expression, gender identity, genetic information, race, national origin, religion, sex, sexual orientation, or status as a protected veteran.
Internal Number: 152837
About The University of North Carolina at Chapel Hill
Carolina rates among the nation’s great institutions of higher education, set on an historic and beautiful campus that celebrates all four seasons. Carolina’s students, faculty and staff come here from around the world, bringing varied cultural, racial and ethnic heritages that help make UNC-Chapel Hill a thriving intellectual center. We’re repeatedly ranked the nation’s best value in higher education for students seeking to earn a college degree – the University has garnered the top spot each time since the ranking’s launch in 1998.Whether you’ve just started your career, are new to academia or are a seasoned professional with assorted campus experiences to draw on, we hope you will find a great place at Carolina.