IRB SPECIALIST

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:

• Preliminary review of study-related documents received in the IRB office in their assigned therapeutic area(s), including new studies, continuing reviews, amendments, and safety events.

• Review and, where necessary, edit consent forms, protocol summaries, and requests for Waiver or Alteration of Consent and HIPAA Authorization to ensure consistency with the federal regulations and Duke policy concerning research involving human subjects. 

• Determine if amendments, new studies, and renewals qualify for expedited review according to the requirements of the federal regulations.

• Coordinate the sending of modification requests, review of modification replies, and issuance of approval letters to the research personnel in his/her assigned therapeutic areas. 

• Complete changes of key personnel within the IRB software (iRis)

• Build agenda for convened IRB meeting
• Assist with meeting conduct and coordination, including assignment of reviews. 

• Confirm attendance, arrange lunches, maintain quorum count, and provide administrative assistance for attending members. 

• Record minutes of the convened IRB meeting

• Answer basic questions from researchers and study teams regarding federal regulations and Institutional practices as they relate to IRB submissions. 

• Assist Primary Reviewers in their assigned reviews

• 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.

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.