School of Medicine:

Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.

Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Occupational Summary

This position reports to the Executive Director, DUHS IRB.

Review, require modifications of, and, where appropriate, approve submissions to the DUHS IRB concerning research with human subjects, lead meetings of the convened IRBs, participate in the formulation of IRB policies, and provide guidance to DUHS researchers, IRB members and IRB staff. As the senior IRB Chair, provide, in conjunction with the Executive Director, leadership, communication and feedback to other IRB chairs.

Work Performed

Lead convened IRB meetings, ensuring that such meetings are conducted according to all applicable federal, state and DUHS regulations/guidelines and policies that govern research with human subjects. Chairing or Co-chairing multiple meetings in one month may be required, as determined by the Executive Director.

In conjunction with the Executive Director and IRB Compliance Director, play a key role in preparation of AAHRPP re-accreditation submissions.

Communicate, in the form of monthly meetings, correspondence, and/or one-on-one meetings with the other IRB chairs and co-chairs regarding policies, performance issues, scheduling, etc. Liaison with other Duke offices such as the Office of Regulatory Affairs and Quality (ORAQ), the Investigational Drug Service (IDS), and the Institutional Biosafety Committee (IBC) on issues that affect research and Duke institutional policies.

Coordinate the reviews of individual patient IND submissions. Conduct, when applicable, expedited review of new study submissions, continuing review submissions, amendments and all other study-related IRB submissions in accordance with all applicable federal, state and DUHS regulations/guidelines and policies.

In conjunction with the IRB Compliance Director, apprise Chairs of important new legislation from FDA and OHRP that affects the review of research involving human subjects. In conjunction with the Executive Director, formulate and disseminate DUHS IRB policies and guidance concerning research with human subjects.

Assist in training DUHS IRB members and participate in IRB-sponsored internal workshops. Provide continuing education and counsel to DUHS researchers, IRB staff, and IRB members regarding research with human subjects. Represent the DUHS IRB in institutional meetings and at extramural conferences.

Assist in managing conflict-of-interest issues of the institution, researchers, and IRB members as those conflicts affect the IRB review of research with human subjects. Perform other activities related to ensuring regulatory compliance of human subject research, as assigned.

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.

Required Qualifications at this Level

Education/Training:

Work requires an advanced degree in a scientific field (e.g., MS, MSN, PhD, MD, Pharm.D.).

Experience:

Minimum of five years of experience as an IRB member is required. Clinical research experience is desired but not required.

Skills:

Knowledge of, and familiarity with, the guidelines and regulations governing research with human subjects and the use of investigational drugs/devices/biologics.

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.

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.