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The Dana-Farber Cancer Institute (DFCI) is a world leader in basic and clinical research, training, and application of advanced diagnostic and treatment methods relating to cancer. The National Cancer Institute named Dana-Farber as one of the country's seven original comprehensive cancer centers in 1973. Today, Dana-Farber is the administrative hub for the Dana-Farber/Harvard Cancer Center, (described below), one of more than forty NCI designated comprehensive cancer centers.
DANA-FARBER/HARVARD CANCER CENTER
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. Cancer Center members have well-recognized expertise in the three major cancer research disciplines: basic, clinical, and population science. 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.
The Office for Human Research Studies (OHRS) functions as the central office for managing the scientific and ethical review and approval of cancer-related clinical research involving human subjects conducted by DF/HCC, with specific responsibilities for supporting the Protocol Review and Monitoring System and the Institutional Review Board. The Director of OHRS works closely with other offices in the management, integration and improvement of the key processes that support 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 DF/HCC consortium (Dana-Farber Cancer Institute, Beth-Israel Deaconess Medical Center; Boston Children's Hospital, DFCI, Brigham and Women's Hospital; and Massachusetts General Hospital) to ensure efficient, responsive and collaborative operations
PRIMARY DUTIES AND RESPONSIBILITIES:
The Director is a highly experienced, strategic and 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. Specifically, the Director of OHRS is responsible for the leadership and effective management of the office in ensuring the administrative and regulatory management, implementation and operation of the (1) Protocol Review and Monitoring System, consistent with the NCI guidelines for Comprehensive Cancer Centers and the Cancer Center Support Grant (CCSG); (2) the system for the institutional review board review of research; (3) the Health Improvement Portability and Accountability Act as it relates to human subjects research; The Director is also involved in the 1) identification and resolution of relevant related issues that cross DF/HCC institutions or DFCI specifically, and, (2) addressing various other regulatory areas that impact cancer clinical research as it falls within the jurisdiction of the Institutional Review Board. The Director is also responsible for management and negotiation of institutional reliance agreements, in consultation with the Office of the General Counsel.
There are more than 400 new trials reviewed each year and a total of 2000 open protocols that require continuing Scientific Review Committee and IRB review The DFCI IRB is the IRB of record for all DF/HCC clinical trials.
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 scientific review of all cancer research 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; continuing oversight and guidance of issues arising within this review process. OHRS manages 2 scientific review committees.
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 and safe review of research involving human subjects. At this time, OHRS is managing 7 institution review boards with members from all five of the DF/HCC institutions.
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.
The Director is expected to have a background in Human Subjects Protections and to maintain contacts with other similar entities to ensure that the OHRS is aligned with national standards.
The Director OHRS, also is a member or ex-officio member of numerous committees including the Data and Safety Monitoring Committee; the Audit Committee; Clinical Operations Committee as well as the Clinical Investigations Committee.
The Director, OHRS also 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.
Authority for Decision Making
The Director, OHRS reports to the Senior Vice President for Research Administration, who also serves as the Institutional Official for both DFCI and DF/HCC, consults on issues with the Medical Director for Clinical Trials Operations, DF/HCC, and is aids and advises the various Human Subjects Protection Committees.
In situations related to IRB matters, the decision-making authority of the incumbent is typically not absolute, but rather subject to the approval of the Senior Vice President for Research Administration or policy constraints. In most situations, the Senior Vice President for Research Administration delegates the authority for decision making to this position, although it is fully expected that there is effective communication, reporting and advice seeking. The Director, OHRS is expected to recognize which decisions are likely to be controversial and will notify the Senior Vice President for Research Administration and other relevant senior management of the potential consequences. In other instances, the Director may act, but remains responsible for communicating to the Senior Vice President for Research Administration about the issues, impact and rationale for action.
Areas where the authority for decision making is delegated to this position are:
Setting priorities for the OHRS
Institutional signatory authority on human subject compliance correspondence to Federal and State agencies.
Recipient of correspondence from other institutions under any IRB authorization agreements.
Reallocation of OHRS staff resources to streamline operations or when there is a conflict in priorities.
PRINCIPAL RESPONSIBILITIES AND CHALLENGES
Provide leadership to the effective and efficient operations of OHRS and its related committees. As a key 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.
Maintain positive relationships with a wide variety of internal and external stakeholders from employees to vendors to State and Federal agencies.
Serve as liaison between Institute and Federal and state agencies on matters relating to human subject protection and other issues under the jurisdiction of OHRS.
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.
Advise on policies and procedures impacting institutional compliance with Federal and state regulations relating to scientific review and human subject research
Prepare DFCI Human Assurance submissions and IRB registrations to the Federal Office for Human Research Protections (OHRP) and FDA.
Coordinate as necessary and participates 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.
The position requires a 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.
An understanding of the CCSG guidelines governing cancer centers as well as relevant Federal and State regulations and guidelines on research involving human subjects.