|Department||Ofc of Human Research Ethics-621300|
|Career Area||Research Professionals|
|Posting Open Date||09/12/2023|
|Open Until Filled||No|
|Position Type||Permanent Staff (EHRA NF)|
|Working Title||IRB Analyst|
|Appointment Type||EHRA Non-Faculty|
|Full Time/Part Time||Full-Time Permanent|
|Hours per week||40|
|Position Location||North Carolina, US|
|Hiring Range||$53,772 - $72,826|
|Proposed Start Date||11/01/2023|
|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.
|Preferred Qualifications, Competencies, and Experience||
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.
|Special Physical/Mental Requirements|
|Campus Security Authority Responsibilities||
Posting Contact Information
|Department Contact Name and Title||Trent Hopper, HR Consultant|
|Department Contact Telephone or Emailfirstname.lastname@example.org|
|Office of Human Resources Contact Information||
If you experience any problems accessing the system or have questions about the application process, please contact the Office of Human Resources at (919) 843-2300 or send an email to email@example.com
|Equal Opportunity Employer Statement||
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.
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