IRB Analyst
2 weeks ago
Ofc of Human Research Ethics-621300
Career Area :Research Professionals
Posting Open Date:05/09/2024
Application Deadline:05/22/2024
Open Until Filled:No
Position Type:Permanent Staff (EHRA NF)
Working Title:IRB Analyst
Appointment Type:EHRA Non-Faculty
Position Number:20063832
Vacancy ID:NF0008133
Full Time/Part Time:Full-Time Permanent
FTE:1
Hours per week:40
Position Location:North Carolina, US
Hiring Range:Dependent on Experience/Qualifications
Proposed Start Date:06/01/2024
Be a Tar Heel:A global higher education leader in innovative teaching, research and public service, the University of North Carolina at Chapel Hill consistently ranks as one of the nation’s top public universities. Known for its beautiful campus, world-class medical care, commitment to the arts and top athletic programs, Carolina is an ideal place to teach, work and learn.One of the best college towns and best places to live in the United States, Chapel Hill has diverse social, cultural, recreation and professional opportunities that span the campus and community.University employees can choose from a wide range of professional training opportunities for career growth, skill development and lifelong learning and enjoy exclusive perks for numerous retail, restaurant and performing arts discounts, savings on local child care centers and special rates on select campus events. UNC-Chapel Hill offers full-time employees a comprehensive benefits package, paid leave, and a variety of health, life and retirement plans and additional programs that support a healthy work/life balance.
Primary Purpose of Organizational Unit:The Office of Human Research Ethics (OHRE) administers, supports, and oversees the work of the Institutional Review Boards (IRBs) and all related activities at UNC-Chapel Hill. Any research project involving human subjects proposed by a member of the faculty, a postdoc, a staff member, or a student at UNC-Chapel Hill must be reviewed and approved by an IRB before that research may begin and before related grants may be funded. These IRBs are federally mandated review committees, operating under regulations promulgated by the Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services (DHHS) and the U.S. Food and Drug Administration (FDA).
The IRBs and OHRE are critical components of UNC-Chapel Hills Human Research Protection Program (HRPP) that serves to protect the rights and welfare of more than one million human research subjects who take part in more than 6,000 different research projects each year at UNC-Chapel Hill. All components of the HRPP must work together to ensure institutional compliance with ethical principles and regulatory requirements.
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.
Minimum Education and Experience Requirements: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.
Required Qualifications, Competencies, and Experience:- 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.
Campus Security Authority Responsibilities:Not Applicable.
