IRB Compliance Analyst
Company: UNC-Chapel Hill
Location: Chapel Hill
Posted on: April 3, 2026
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Job Description:
Position Summary The Compliance Analyst is responsible for
Compliance functions in the Office of Human Research Ethics ( OHRE
), including (1) triage and review of Promptly Reportable
Information ( PRI ), (2) conducting fact-finding to prepare
information for the Institutional Review Board ( IRB ), evaluating
Corrective and Preventative Action plans, (4) documenting decisions
and controverted issues by the IRB , (5) collaborating with partner
UNC offices that contribute to reviews of compliance events, (6)
monitoring the execution of compliance-related tasks, and (7)
independently compose memos and letters. The Compliance Analyst may
also serve as primary or secondary reviewer and an alternate voting
member for each of the IRBs. The Compliance Analyst will ensure
appropriate execution of OHRE Standard Operating Procedures (SOPs)
and contribute to continual improvements to Compliance-related
guidance, participate in process improvement initiatives and
represent the program in meetings and discussions. The person in
this role will also serve as a subject matter expert on federal
regulations and OHRE SOPs pertaining to Unanticipated Problems and
Noncompliance for investigators, study teams, IRB Chairs and
members, OHRE personnel, and other relevant UNC departments,
offices, centers, and institutions. The Analyst will also be
responsible for assigned aspects of the AAHRPP re-accreditation
process. Required Qualifications, Competencies, And Experience The
candidate must have the ability to exercise sound judgment and
facilitate good and timely decisions that comport with the
university objectives and federal regulations pertaining to human
subjects research. Preferred Qualifications, Competencies, And
Experience The preferred applicant will have full knowledge of
applicable federal regulations governing human subjects research
(21 CFR 50 & 56; 45 CFR 46), including regulations pertaining to
Unanticipated Problems Involving Subjects or Others, Serious and
Continuing Noncompliance, and Suspensions and Terminations of
Approval (45 CFR 46.108; 21 CFR 56.108),Good Clinical Practice,
HIPAA Privacy Rule.
Keywords: UNC-Chapel Hill, Durham , IRB Compliance Analyst, Legal , Chapel Hill, North Carolina
