IRB SPECIALIST, SENIOR (Durham, NC, US, 27710)
School of Medicine:
Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.
Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
This position is responsible for preliminary review of study-related documents received in the IRB office, including renewal submissions, amendments, waiver requests, Notifications of Review Preparatory to Research, and general study-related correspondence. This position will have assigned therapeutic areas from 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
- 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 assembly, copying and distribution of packets for the meeting.
- This position will confirm attendance, arrange lunches, 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.
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.
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 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
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description
Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.