Position Type: Permanent Staff
Department: Ofc of Human Research Ethics - 621300
Appointment Type: EHRA Non-Faculty
Vacancy ID: NF0002804
Position Summary: The Office of Human Research Ethics (OHRE) is responsible for ethical and regulatory oversight of research at UNC-Chapel Hill that involves human subjects. OHRE administers, supports, guides and oversees the work of the Institutional Review Boards (IRBs), and all related activities. These IRBs are federally mandated review committees, operating under regulations from the Office for Human Research Protections (OHRP, DHHS) and the Food and Drug Administration (FDA). The OHRE and IRBs are critical components of a program that serves to protect the rights and welfare of human research subjects. All components of this program, coordinated through the OHRE, must work together to ensure institutional compliance with ethical principles and regulatory requirements. Additionally, in accordance with the mission of OHRE, the goals are to ensure compliance with federal regulations and university policy, and to promote best practices in human research protections. This can best be accomplished by consistent application of policies and procedures and standardized documentation of IRB actions. This position is responsible for oversight, management and support of operational issues within the Office of Human Research Ethics (OHRE).
Education Requirements: Relevant post-Baccalaureate degree required; for candidates demonstrating comparable independent research productivity or professional-level background in sponsored research administration, will accept a relevant undergraduate degree and 5 or more years of relevant experience in substitution.
Qualification and Experience: Certification as Certified IRB Professional (CIP) is required. At least five years' experience with Institutional Review Boards, preferably in a senior managerial capacity. Ability to communicate effectively in both writing and orally, inside and outside the University. This includes interactions that will represent UNC-CH nationally, as well as internal interactions with other administrators and researchers. Working knowledge of the federal regulations that govern research involving human subjects, including FDA (21 CFR 50 and 56), HHS (45 CFR 46) and HIPAA (45 CFR 160 and 164). Familiarity with international standards for human research is desirable.
Equal Opportunity Employer: 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, national origin, race, religion, sex, sexual orientation, or status as a protected veteran.
Department Contact Name and Title: Laura C. Munn, Office Manager and Assistant to OHRE Director and/or Elizabeth Kipp Campbell, Director
Special Instructions for Applicants: