School of Medicine
Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.
Primary role:
IRB Specialists will develop a working knowledge of the federal regulations and Institutional practices, as they relate to human subjects research, as well as the electronic application system and Institutional practices
This position is responsible for preliminary review of study-related submissions received in the IRB office, including: initial reviews, renewal submissions, amendments, and safety events. This position will have assigned therapeutic areas and 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.
Essential tasks/responsibilities:
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.
Education/training:
Bachelor’s degree required, as the work requires communication, analytical and organizational skills and a general business background.
Experience:
A minimum of two years of experience in an administrative or regulatory environment to allow for interpretation and application of regulations. Direct experience in a human research protections program or IRB preferred.
Equivalency:
A combination of educational attainment and direct human subjects research or IRB experience may be used to meet the education and experience requirements. For example, a two year master's degree may be used in lieu of two years of experience, or six years of direct experience may be used in lieu of both the education and 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
Work requires communication and analytical skills normally acquired through a 4 year college education
OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
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.
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