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IRB SPECIALIST, SENIOR
Job Title: IRB SPECIALIST, SENIOR
Job Code: 2539
FLSA: E
Job Level: 13
Revised Date: 05/01/2022
Job Family: JF 28
Occupational Summary
This position is responsible for in-depth review of renewals and amendments to existing protocols, including consent form editing and determination of qualification for expedited review.
Work Performed
Completes in-depth review of submissions for assigned therapeutic areas and makes recommendations to IRB Chairs/Vice Chairs/Directors.
Edits consent forms for new studies as needed.
Reviews amendment shelf to determine qualification for expedited review.
Provides guidance and training to Principal Investigators and study coordinators regarding IRB submissions.
Records minutes of IRB meetings as back-up to Medical Editors/Instructors (Writers).
Works with Meeting Team (Chair, Vice Chair, Writer and another Board Specialist) to carry out all responsibilities associated with 1 monthly convened IRB (agenda building, reviewer assignment, packet preparation, delivery, maintenance of quorum and voting during meeting).
Required Qualifications at this Level
Education/Training
Work requires communication, analytical and organizational skills and a general business background normally acquired through completion of a bachelors degree.
Experience
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
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.
