IRB SPECIALIST,SENIOR (Durham, NC, US, 27710)
Duke University was created in 1924 through an indenture of trust by James Buchanan Duke. Today, Duke is regarded as one of America’s leading research universities. Located in Durham, North Carolina, Duke is positioned in the heart of the Research Triangle, which is ranked annually as one of the best places in the country to work and live. Duke has more than 15,000 students who study and conduct research in its 10 undergraduate, graduate and professional schools. With about 40,000 employees, Duke is the third largest private employer in North Carolina, and it now has international programs in more than 150 countries.
The Campus IRB Specialist is responsible for advising and assisting faculty, students, staff and administrators with the preparation of research protocols that protect the rights and welfare of human subjects in accordance with all applicable regulations and policies including federal regulations, state and local law, and Duke policy.
Campus IRB support:
- Advise and assist faculty, students, staff, and administrators in the design of ethical research, providing discipline-specific guidance using pre-review and consultation.
- Provide regulatory interpretation (federal, state, and local law, Duke and IRB policy) for faculty, students, staff and administrators who may be preparing research protocols.
- Conduct preliminary reviews of protocol submissions, including risk/benefit analyses and determination of appropriate level of review.
- Write memoranda for researchers summarizing the outcome of pre-review, including rationale for proposed changes.
- Act as liaison between the IRB and Duke faculty, students, staff and administrators.
- Assist the Program Director in development of policy and resource materials.
- Conduct seminars and workshops for students, staff and faculty.
- Develop in-service training for the IRB.
- Assist the Program Director with initiatives and projects as needed.
- Prepare agreements with other institutions engaged in collaborative research with Duke.
- Correspond with external agencies regarding research.
- Respond to inquiries from research subjects.
Required Qualifications at this Level
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.
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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.