The Office for Human Research Studies (OHRS) functions as the central office for managing the ethical and scientific review and approval of all cancer-related clinical research protocols conducted by DF/HCC, with specific responsibilities for supporting the Institutional Review Board and the Protocol Review and Monitoring System.
We are currently seeking Director of OHRS who is highly experienced, strategic and a well-respected leader who has in-depth knowledge of the numerous issues impacting the review, approval and oversight of clinical and non-clinical research involving human subjects. The Director of OHRS provides leadership to staff, and works in close collaboration with other offices in the management, integration and improvement of the key processes that support clinical oncology research. The Director of OHRS works closely with senior clinical trials officials (e.g., clinical trials office, IRB office) and faculty of all of the institutions that participate in the Dana-Farber/Harvard Cancer Center (DF/HCC) consortium (see below for more detail) to ensure efficient, responsive and collaborative operations.
Specifically, the Director of OHRS is responsible for the leadership and effective management of the office in ensuring administrative and regulatory management and implementation and operation of:
The Institutional Review Board (IRB) review of research;
The Protocol Review and Monitoring System, consistent with the NCI guidelines for Comprehensive Cancer Centers and the Cancer Center Support Grant (CCSG);
The Health Improvement Portability and Accountability Act as it relates to human subjects research.
The Director is also involved in:
Identification and resolution of relevant issues that cross DF/HCC institutions or DFCI specifically
Addressing regulatory areas that impact cancer clinical research as it falls within the jurisdiction of the IRB.
The Director is also responsible for management and negotiation of institutional reliance agreements, in consultation with the Office of the General Counsel.
The Director is a member or ex-officio member of numerous committees including the Data and Safety Monitoring Committee, the Audit Committee, the Clinical Operations Committee, as well as the Clinical Investigations Leadership Committee. The Director represents DFCI, as appropriate, at such groups such as the Harvard Catalyst.
The Director is part of both DFCI and DF/HCC administration. As such the Director is expected to work collaboratively with other senior managers within these organizational structures, as well as faculty leaders, departments, individual faculty and staff, as well as those in member institutions and relevant other organizations.
DANA-FARBER / HARVARD CANCER CENTER (DF/HCC):
Founded in 1998, the DF/HCC unites the major clinical, population, and basic cancer research efforts of the Dana-Farber Cancer Institute, the Harvard Medical School and Harvard T.H. Chan School of Public Health, Beth Israel Deaconess Medical Center, the Brigham and Women's Hospital, Boston Children's Hospital, and Massachusetts General Hospital.
DF/HCC is the largest of the Comprehensive Cancer Centers formally designated by the National Cancer Institute. The DF/HCC links more than 1100 cancer scientists into an organizational structure designed to foster the interaction and collaboration that will lead to new, more effective approaches cancer prevention, diagnosis, and treatment. Research in the Center is carried out in 17 disease-and-discipline based programs that cross both institutional and scientific boundaries. The Center also provides infrastructure for more than 16 core facilities that provide shared resources to Center members, facilitating scientific progress. Together, these programs and core facilities are fundamental to the multi-modality approach to clinical, as well as non-clinical, research and care. The Dana-Farber/Harvard Cancer Center supports the infrastructure for this unified expanded system of cancer research clinical trials.
There are more than 400 new trials reviewed each year and a total of 2000 open protocols that require continuing IRB review and Scientific Review Committee review. The DFCI IRB is the IRB of record for all cancer relevant trials across all seven DF/HCC consortium members.
Institutional Review Board Review: The OHRS is responsible for implementing the mandate of the Federal Regulations for the Protection of Human Subjects in Research by forming and maintaining an adequate and appropriate number of Institutional Review Boards to ensure efficient review of ethical and safety standards for research involving human subjects. At this time, OHRS manages 7 institution review boards with members from all five of the DF/HCC institutions.
Protocol Review and Monitoring System: Under the CCSG guidelines, the DF/HCC is required to maintain a protocol review and monitoring system. This system ensures appropriate and adequate review of scientific merit, prioritization and annual progress monitoring of all cancer clinical research protocols conducted by the five clinical institutions that comprise the DF/HCC. OHRS is responsible for meeting the needs of scientific review of research by forming and maintaining committees; providing guidance and training to members; and providing oversight and guidance of issues arising within this review process. OHRS manages 4 scientific review committees.
HIPAA: The Health Insurance Portability and Accountability Act is a separate regulatory scheme that requires a system to ensure the protection of protected health information for individuals who participate in research. OHRS is responsible for ensuring compliance with the requirements of HIPAA; communication and coordination with the other DF/HCC institutions as appropriate; as well as direct operationalization of HIPAA in the maintenance of a privacy board.
Provide leadership to the effective and efficient operations of OHRS and its related committees.
As a member of the leadership team of DF/HCC Administration and DFCI Office of Research, keep management informed with respect to all pertinent matters related to OHRS
Assist leadership on all long and short-term objectives and other strategies necessary to achieve the organization's mission, goals and objectives.
Assure that processes in use throughout OHRS are efficient and advise executive and senior management and professional staff on issues involving Federal and State regulations involving human subjects protection.
Serve as liaison between Institute and Federal and state agencies on matters relating to human subject protection and other issues under the jurisdiction of the IRB.
Advise on policies and procedures impacting institutional compliance with Federal and state regulations relating to scientific review and human subject research
Maintain positive relationships with a wide variety of internal and external stakeholders from employees to vendors to State and Federal agencies.
Prepare DFCI Human Assurance submissions and IRB registrations to the Federal Office for Human Research Protections (OHRP) and FDA
Coordinate as necessary and participate in regulatory agency site visits and audits.
Work to assist the Office of Research Administration in its continued efforts at productivity and cost improvements in all areas.
Serve as a mentor to OHRS staff, overseeing and supporting their professional growth, evaluating their performance as appropriate and improving the quality of their work.
At all times understand and exemplify the mission and values of DFCI and the DF/HCC.
Perform other related tasks as assigned or needed.
The Director provides general management and supervision to OHRS staff and coordinates the activities of faculty reviewers. The Director is responsible for the supervision of the operations of over 200 committee meetings per year; 7 IRB boards; 4 Scientific Review Committees; and approximately 35 staff members.
Bachelors degree with a minimum of 10 years of relevant experience; or, an advanced degree (e.g. MBA, MPH, MA/MS, JD, PhD) with 7 years experience ideally in a NCI designated comprehensive cancer center and large academic medical center. An advanced degree is highly preferred.
5+ years of direct supervisory/management experience. Previous leadership experience combined with a proven and demonstrated track record of leading others and achieving outstanding results.
In-depth knowledge of the numerous issues impacting the review, approval, and monitoring of clinical and non-clinical research involving human subjects
Background and knowledge in Human Subjects Protections, and ability to maintain contacts with other similar entities to ensure that the OHRS is aligned with national standards.
Located in Boston and the surrounding communities, Dana-Farber Cancer Institute (DFCI) brings together world renowned clinicians, innovative researchers and dedicated professionals, allies in the common mission of conquering cancer, HIV/AIDS and related diseases. Combining extremely talented people with the best technologies in a genuinely positive environment, we provide compassionate and comprehensive care to patients of all ages; we conduct research that advances treatment; we educate tomorrow's physician/researchers; we reach out to underserved members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.
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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