IRB Specialist, Senior

Duke Careers • Durham, NC

10d • $61,535 - $95,880 • Hybrid

About The Position

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
Play a key role in supporting ethical, compliant clinical research at Duke.

This position serves as a primary point of review and guidance within the IRB office, performing preliminary reviews of study‑related documents including renewals, amendments, waiver requests, Notifications of Review Preparatory to Research, and general study correspondence. Assigned to specific therapeutic areas within clinical research units (CRUs) that participate in complex and/or greater than minimal risk interventional trials. This position will interact daily with research personnel from his/her assigned areas, answering questions and providing assistance concerning IRB policy and procedures. In addition, this position will provide guidance to any DUHS research personnel regarding IRB submissions, including electronic IRB submissions.

The candidate for this position would be expected to:

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.

Requirements

• 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.
• 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.

Nice To Haves

• Some experience in a human research protections program in the social and behavioral sciences preferred.

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.

Benefits

• Duke provides comprehensive and competitive medical and dental care programs, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees