Official Title:	Director of Institutional Review Board (IRB)
Reports to:	Assistant Dean for Research

Apply online at: http://www1.wfubmc.edu/wfuhs_hr/

Overview

The IRB Director is responsible for oversight, administration and coordination of
policies, procedures and activities related to the protection of the safety,
rights and welfare of human research subjects, and for ensuring institutional
compliance with governmental regulations related to human subjects
research.  This leadership position is a key administrative position located
administratively in the Office of Research. Expert knowledge and experience
with the IRB process, including an appreciation of the ethical implications of
clinical investigation and an intimate understanding of governmental
regulations pertaining to human research is required.

Primary Responsibilities

Maintains expert knowledge and experience with IRB process, including an
appreciation of the ethical implications of human research and an intimate
understanding of governmental regulations pertaining to human research

Interprets and applies federal and state regulations and institutional policies
and procedures related to research involving human subjects

Works closely with the Assistant Dean for Research, Executive Chairman of
the IRB, the WFU Compliance Officer, the Director of Environmental Health and
Safety, the Privacy and Security Officers, faculty, staff and others to ensure
institutional compliance with the ethical and regulatory requirements for
human subjects research

Provides liaison with the Office for Human Research Protections, Department
of Health and Human Services, the Food and Drug Administration, and other
federal and state agencies on IRB issues; represents Wake Forest University
School of Medicine nationally on human research matters; serves as the
principal point of reference and consultation for IRB issues

Specific Duties and Responsibilities

Monitors and coordinates IRB activities
•	Plans, coordinates, and directs IRB workflow
•	Develops and implements institutional policies and procedures to
ensure compliance with federal, state and local regulatory guidelines related to
the protection of human research subjects
•	Communicates, negotiates, and resolves sensitive and confidential
issues related to human subjects research
•	Provides educational activities to Wake Forest University and Wake
Forest University School of Medicine students, residents and fellows
•	Develops and presents educational programs and/or workshops for
IRB members, faculty, and support staff on the protection of human subjects
•	Provides guidance and consultative services to clinical investigators
and research staff

Planning and Operations
•	Prepares an annual operating budget for the IRB
•	Analyzes and evaluates ongoing programs to identify areas where
adjustments/improvements are needed
•	Evaluates IRB organizational functions and structures to determine
the best allocation and utilization of resources
•	Regularly communicates with and reports to members of institutional
administration and management on issues relate to the IRB and human
research subjects
•	Develops goals and objectives based on interpretation of institutional
and regulatory policy
•	Maintains institutional assurance, registration, approvals and/or
accreditations needed for the conduct of human research

Personnel administration
•	Directs and supervises IRB staff
•	Implements personnel actions (e.g., hiring, promotion, termination,
and organizational changes)

Requirements
•	Undergraduate degree required, Graduate degree preferred
•	Demonstrated leadership, knowledge and administrative experience
with relevance to regulatory compliance and research with human subjects
•	Three years relevant IRB leadership experience in the past 7 years
•	Professional certification in IRB or Research Administration preferred
•	Excellent written and oral communication skills and experience with
computerized databases and word processing
•	Demonstrated ability to work independently
•	Strong interpersonal skills and attention to detail
•	Supervisory experience

Apply online at: http://www1.wfubmc.edu/wfuhs_hr/
Resumes may be sent to Ms. Paula Means, Assistant Dean for Research, Wake
Forest University School of Medicine, Medical Center Boulevard, Winston-
Salem, NC 27157-1023.

Equal Employment Opportunity

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