The Office for Human Research Studies (OHRS) manages Scientific Review and Institutional Review Board (IRB) review for the institutions that comprise the Dana-Farber Harvard Cancer Center (DF/HCC): Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Boston Children's Hospital, Dana-Farber Cancer Institute and Massachusetts General Hospital. There are five Scientific Review Committees (SRC) and seven IRBs that oversee cancer related human subject research for DF/HCC. As of May 2017, the OHRS manages more than 3,000 new and ongoing DF/HCC research protocols with more than 12,000 submissions received for SRC / IRB review per year. OHRS is also responsible for HIPAA review of research.
The Associate Director is responsible for representing OHRS at DFCI and DF/HCC meetings and ensuring decisions are compliant with the human subject protection regulations. The Associate Director is expected to work independently, and can see the high level operational and substantive issues and devise appropriate management plans. This individual must have solid oral and writing skills and can effectively communicate with senior officials at all the Harvard clinical institutions that operate under the umbrella of the DF/HCC.
The Associate Director is a member of the OHRS Senior Staff and reports to the Director. The Associate Director supervises the Senior Human Research Coordinators (HRC) and indirectly all the protocol focused HRCs. The Associate Director is responsible for ensuring staff compliance with the Cancer Center Support Grant (CCSG) Protocol Review and Monitoring (PRMS) requirements as they relate to SRC review as well as compliance with FDA and HHS regulations for IRBs.
PRIMARY DUTIES AND RESPONSIBILITIES:
Bachelor's degree required
Advanced degree in law, policy or ethics or seven years of experience in regulatory compliance required.
Must have at least four years of experience in a cancer center and/or working with an academic IRB.
Must have at least four years of staff management experience.
Demonstrated expertise in application of federal regulations to non-clinical research.
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other groups as protected by law.
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