|Department||Ofc of Human Research Ethics-621300|
|Career Area||Research Professionals|
|Is this an internal only recruitment?||No|
|Posting Open Date||03/20/2023|
|Position Type||Permanent Staff (SHRA)|
|Position Title||Soc/Clin Research Specialist - Journey|
|Salary Grade Equivalent||GN11|
|Working Title||IRB Reliance Analyst|
|Full-time/Part-time Permanent/Time-Limited||Full-Time Permanent|
|If time-limited, estimated duration of appointment|
|Hours per week||40|
Monday – Friday, 8:00am – 5:00pm
|Work Location||Chapel Hill, NC|
|Position Location||North Carolina, US|
|Hiring Range||$53,772 - $72,826|
|Pay Band Information||
To learn more about the pay band for this branch and role, please see the Career Banding rates spreadsheet .
Position Summary Information
|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.
This position may be eligible for a hybrid work arrangement that may include a partially remote work location, consistent with System Office policy. UNC Chapel Hill employees are generally required to reside within a reasonable commuting distance of their assigned duty station.
This position is part of UNC-CH’s Office of Human Research Ethics (OHRE) reliance team and works under the supervision of the IRB Reliance Manager and the Associate Director of Regulatory Affairs and Compliance.
The IRB Reliance Analyst serves as an expert consultant on the Reliance Processes. This position is responsible for processing and reviewing submissions where study teams request to rely on external institutions or IRB’s and reviewing requests for external institutions or investigators to rely on UNC.
This position supports the Reliance Team with developing and updating outward and inward facing guidance materials on Reliance.
In addition, the IRB Reliance 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 Reliance Agreements 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||
|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 firstname.lastname@example.org
Please note: The Office of Human Resources will not be able to provide specific updates regarding position or application status.
|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, race, national origin, religion, sex, sexual orientation, or status as a protected veteran.
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