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ASSOC DIR, IRB
Job Title: ASSOC DIR, IRB
Job Code: 2636
FLSA: E
Job Level: 14
Revised Date: 01/20/2015
Job Family: JF 28
Occupational Summary
Assist with the day-to-day management of the program's operation by coordinating the activities of program staff and ensuring that submissions to the program are responded to in a timely and appropriate manner. The Associate Director has the primary responsibility for making determinations about whether research is exempt and is authorized to sign on behalf of the University for initial protocols that may be exempt and for subsequent exemption-related submissions. This position reports to the Program Director.
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.
Required Qualifications at this Level
Education/Training
Work generally requires organizational, analytical and communication skills normally acquired through the completion of a bachelor's degree program. Masters degree preferred.
Experience
A minimum of four 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
Skills
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 University 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 essential job 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.
