Quality Improvement/Assurance Manager
Position Type: Permanent Staff
Department: Ofc of Human Research Ethics - 621300
Appointment Type: EHRA Non-Faculty Research
Vacancy ID: NF0002518
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. Deficiencies in this area have led to very public suspensions of research at several peer universities, which have been very costly and damaging for these institutions. As serious as this would be, an even greater harm could result if errors or lack of proper oversight by this office resulted in harms to human subjects. Compliance oversight has been identified as a key area of concern at UNC-Chapel Hill. The Quality Improvement/Assurance Manager reports to the Director of the Office of Human Research Ethics and through the Director to the Associate Vice Chancellor for Research Compliance and through to the Vice Chancellor for Research. S/he will be responsible for developing and implementing a program for monitoring OHRE quality and performance at an operational level and for the generation and implementation of corrective and preventative action (CAPA) plans in order to facilitate a high level of quality and compliance. 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.
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 3 or more years of relevant experience in substitution.
Qualification and Experience: Minimum of 3 years' of human subject's protection /IRB experience with knowledge of the federal regulations required. Experience with quality assurance/improvement methods preferred. Additional required qualifications include: -Certification as IRB Professional (CIP) required -Must exercise high degree of independent judgement and discretion -Leadership skills and ability to relate to a diverse group of individuals within the office and across campus -Excellent interpersonal skills as well as effective verbal and written communication skills -Evidence of self-motivation and the ability to work both independently and as part of a team -Strong organizational, problem solving and critical thinking skills -Demonstrates self-motivation, initiative, diplomacy, and professional demeanor -Detail-oriented
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: Latisha Johnson, HR Consultant
Department Contact Telephone Number or Email: firstname.lastname@example.org