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PROGRAM DIR, OR&I RES SUPP & OVERSIGHT
Job Title: PROGRAM DIR, OR&I RES SUPP & OVERSIGHT
Job Code: 1433
FLSA: E
Job Level: 73
Revised Date: 09/01/2022
Job Family: JF 05
Occupational Summary
Oversee and develop program to provide regulatory oversight and support to research units and principal investigators. Design, develop, and implement processes and systems to manage and monitor oversight of research activities. Coordinate with research unit leaders and central research office staff (ORS, ORA, ORC, OIT, OARC, IRB) to support handling of research data in compliance with institutional and contractual obligations at the University. Review and as appropriate approve activities for research teams. Supervise the work of staff who provide direct support to research teams.
Work Performed
Collaborate with research leadership in the Office of Research & Innovation and central support offices (ORS, ORC, OIT, OARC, IRB) to develop, operationalize, and manage a program for ensuring regulatory oversight and compliance of research.
Partner to develop and maintain systems or platforms associated with tracking regulatory and administrative controls for research studies. Train other users on system implementation.
Provide oversight and support to principal investigator(s), research staff, and trainees in developing research plans for projects. Ensure that researchers and their teams are aware of regulatory and administrative requirements associated with research projects.
Develop and implement educational opportunities for research teams.
Partner with research school/unit leadership to ensure efficient support and regulatory oversight of individual research projects. Provide training and onboarding to new researchers and staff working with research data.
Create standard operating procedures to ensure research team oversight with institutional and sponsor/federal/provider obligations. Confer with various research offices to collaborate as appropriate.
Supervise the work of other staff providing support and regulatory/administrative oversight of research projects.
Required Qualifications at this Level
Education/Training
Completion of a bachelor's degree, master's degree preferred.
Experience
Work requires a minimum of eight years of research experience (e.g., research, regulatory, compliance, program management). A Master's degree may substitute for two years of related experience.
Requires experience supporting research with protected or regulated data.
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.
