Duke University · 15 hours ago
IRB Specialist, Senior
Durham, NC
Full-time
Hybrid
Mid, Senior Level
$62K/yr - $96K/yr
2+ years expDuke University School of Medicine is a leading medical institution known for its collaborative environment. The IRB Specialist, Senior will play a crucial role in supporting ethical and compliant clinical research by reviewing study-related documents and providing guidance to research personnel regarding IRB policies and procedures.
EdTechEducationHigher EducationUniversities
Responsibilities
Preliminary review of study-related documents received in the IRB office in their assigned therapeutic area(s), including new studies, continuing reviews, amendments, safety events
Review and, where necessary, edit consent forms, protocol summaries, and requests for Waiver or Alteration of Consent and HIPAA Authorization to ensure consistency with the federal regulations and Duke policy concerning research involving human subjects
Determine if amendments, new studies, and renewals qualify for expedited review according to the requirements of the federal regulations
Coordinate the sending of modification requests, review of modification replies, and issuance of approval letters to the research personnel in his/her assigned therapeutic areas
In a team with one other Board Specialist, this position will build an agenda for a monthly IRB meeting and coordinate the distribution of the agendas for the meeting
This position will confirm attendance, arrange lunches (when in-person meetings may be scheduled), maintain quorum count, and provide administrative assistance for attending members at this monthly IRB meeting
Record minutes of the convened IRB meeting
This position will interact more extensively with researchers in answering questions regarding the federal regulations and IRB submissions
Prior to a monthly IRB meeting, this position will assist Primary Reviewers in their assigned reviews by answering questions related to the federal regulations and/or Duke policy and by providing documentation required for the review
In addition, this position will participate more extensively in educational presentations customized for individual therapeutic areas
Perform other related duties incidental to the work described herein
Qualification
Required
Have a demonstrated knowledge of the federal regulations and Institutional practices
Answer complex questions from researchers and reviewers
Assist with educational presentations
Mentor, train, and onboard new staff
Provide input and guidance to development of office practices and/or updates to electronic application system
Have experience working within an IRB
Have proficiency with the electronic application system
Work with complex CRU portfolios
Work requires communication, analytical and organizational skills and a general business background normally acquired through completion of a Bachelor's degree
A minimum of two (2) years of experience in an administrative or regulatory environment to allow for interpretation and application of regulations
Some experience in a human research protections program in the social and behavioral sciences preferred
A related master's degree may offset required years of experience on a 1:1 basis, e.g., a two-year master's degree in lieu of two years of experience
Or An Equivalent Combination Of Relevant Education And/Or Experience
Benefits
Duke provides comprehensive and competitive medical and dental care programs
Generous retirement benefits
A wide array of family-friendly and cultural programs to eligible team members.
Company
Duke University
Duke University is a private research university providing undergraduate and postgraduate education in medicine and other disciplines.
10001+ employees
H1B Sponsorship
Duke University has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (274)
2024 (232)
2023 (202)
2022 (195)
2021 (148)
2020 (121)
Funding
Current Stage
Late StageTotal Funding
$71.15MKey Investors
North Carolina Biotechnology CenterUS Department of EnergyGlaucoma Research Foundation
2023-02-17Grant· $0.11M
2022-09-19Grant
2022-03-09Grant· $0.05M
Leadership Team
Barry Myers
Professor and Director
Dan Ariely
Professor
Recent News
2026-01-11
2025-12-18
Company data provided by crunchbase