Irb Reliance Analyst
Full Time
Chapel Hill, NC 27599
$53,772 - $72,826 a year
Posted Just posted
Job description
Posting Information
Department
Ofc of Human Research Ethics-621300
Career Area
Research Professionals
Is this an internal only recruitment?
No
Posting Open Date
05/12/2023
Application Deadline
06/19/2023
Position Type
Permanent Staff (SHRA)
Position Title
Soc/Clin Research Specialist - Journey
Salary Grade Equivalent
GN11
Working Title
IRB Reliance Analyst
Position Number
20053511
Vacancy ID
P017438
Full-time/Part-time Permanent/Time-Limited
Full-Time Permanent
If time-limited, estimated duration of appointment
Hours per week
40
Work Schedule
Monday through Friday, 8:00 A.M. to 5:00 P.M.
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.
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.
Position Summary
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.
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.
Required Licenses/Certifications
Special Physical/Mental Requirements
Campus Security Authority Responsibilities
Not Applicable.
Position/Schedule Requirements
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