Associate Director, Office for Human Research Studies

Associate Director, Office for Human Research Studies

Overview

This position's work location is fully remote with occasional time onsite as needed. The selected candidate may only work remotely from a New England state (ME, VT, NH, MA, CT, RI).

The Office for Human Research Studies (OHRS) manages Scientific Review and Institutional Review Board (IRB) review for the institutions that comprise the Harvard Cancer Consortium (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 HCC. The OHRS manages more than 3,000 new and ongoing HCC research protocols with more than 14,000 submissions received for SRC / IRB review per year. OHRS is also responsible for HIPAA review of research.

The Associate Director for Education and sIRB represents OHRS at DFCI and HCC meetings and ensures decisions are compliant with the human subject protection regulations. The Associate Director is expected to work independently to identify high level operational and substantive issues and devise appropriate management plans, communicating as necessary with senior officials at all the Harvard clinical institutions that operate under the umbrella of the HCC.

The Associate Director is a member of the OHRS Senior Staff and reports to the Director, HRPP. The Associate Director supervises Senior IRB Analysts and protocol-focused IRB Analysts. The Associate Director also supervises the OHRS Meeting Coordinators. The Associate Director ensures staff compliance with FDA and HHS regulations for IRBs.

The Associate Director Education and sIRB is responsible for the oversight of single IRB responsibilities and educational training including training of OHRS staff and IRB members on institutional review board policies; institutional policy and operations; and representation at meetings of the institutions that comprise the HCC, and Harvard catalyst. The Associate Director also oversees the process of single IRB and leading communication efforts between the DFCI IRB and external IRBs. Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS, and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.

Primary Duties and Responsibilities:

• Oversees the process of review and approval of clinical and non-clinical research.
• Serves as an IRB member on the seven IRB committees. Reviews and oversees IRB determinations to ens