Amy, Sorry, I may have not been clear on my last email. Are the following positions still available? IRB Director IRB Program Manager Cheers, Homer Scott Cavazos, MBA ________________________________ From: Research Administration List on behalf of Amy Comer Sent: Mon 1/12/2009 8:33 AM To: xxxxxx@hrinet.org Subject: [RESADM-L] POSITION AVAILABLE AT WAKE FOREST UNIVERSITY HEALTH SCIENCES 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. 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