Administrative Reviewer

School of Medicine

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 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

We are seeking a detail-oriented and collaborative professional to assist in the day-to-day management of a dynamic program.

Be You.

The Administrative Reviewer plays a key role in coordinating program staff activities and ensuring timely, appropriate responses to submissions. This position holds primary responsibility for determining whether research qualifies as exempt and is authorized to sign on behalf of the University for initial and subsequent exemption-related protocols. Reporting directly to the Program Director, the Administrative Reviewer contributes to the integrity and efficiency of the program's operations.

Work Arrangement - Hybrid

Anticipated Pay Range - Duke University provides an annual base salary range for this position as USD $62,694.00 to USD $107,633.00. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer.

Your total compensation goes beyond the dollars on your paycheck. 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.

Learn more at: https://hr.duke.edu/benefits/

DEPARTMENTAL PREFERENCES

Master's degree preferred.

Some experience in a human research protections program in the biomedical sciences strongly preferred.

MINIMUM QUALIFICATIONS

Education/Training - Work generally requires organizational, analytical and communication skills normally acquired through the completion of a bachelor's degree program.

Experience - A minimum of four (4) 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.

Be Bold.

Work Performed

Make determinations about whether proposed research meets the criteria for exempt review, review requests for screening for exemption, request changes as needed, and approve initial screenings, request to amend and extend exemptions. Review and approve minor amendments and renewals for approved non-exempt protocols, as designated by the IRB.

Coordinate and manage institutional response to reports of non- compliance and unanticipated problems.

Serve as liaison with Duke's Institutional Technology Security Office. Ensure that federally-funded research files are auditable at any time.

Coordinate teaching and outreach activities.

Advise and assist faculty, staff, and students in the design of ethical research, providing discipline specific guidance through pre-review and consultation.

Provide regulatory interpretation of Federal, State, and local law, Duke and IRB Policy for faculty, students, and staff preparing research protocols.

Share best practices and resources and engage in creative problem- solving.

Write memorandum for researchers summarizing the outcome of pre-review, including rationale for proposed changes. After an expedited review is conducted prepare correspondence for the researcher detailing the outcome of the review. Ensure that changes requested by expediting reviewers are implemented or if a researcher provides a rationale for not implementing the changes, act as liaison between the researcher and the IRB member to resolve the issue. Compose detailed correspondence to researchers that convey outcome of reviews by the convened IRB after submissions are reviewed. This may involve working with the primary reviewer.

Uphold the program's customer service model in all interactions with Duke researchers and staff. Respond to inquiries from research subjects.

Assist the Program Director in development of policy and resource materials. Conduct seminars and workshops for students, faculty, and IRB members.

Prepare agreements with other institutions engaged in collaborative research with Duke. Correspond with sponsors regarding research.

Assist the Program Director with initiatives and projects as needed. Perform other related duties incidental to the work described herein.

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Choose Duke.

Ready to Make an Impact?

If you're a strategic thinker with a passion for operational excellence and collaborative leadership, we encourage you to apply for this exciting opportunity. Join a committed team - apply today and help shape the future.