General Overview The Director leads the operations of the Human Research Office (HRO) ensuring that the office effectively and efficiently operates in compliance with applicable state and federal regulations and institutional policies and procedures. The HRO supports the operation of the Mass General Brigham IRBs that provide review and oversight for MGB’s integrated health system of 14 hospitals including Brigham and Women's Hospital and Massachusetts General Hospital, two of the nation's most prestigious teaching and research institutions.
Principal Duties and Responsibilities 1. Provides leadership on all aspects of day-to-day IRB operations. 2. Participates with HRA Vice President, Directors and research leadership in strategic planning; implements strategic plan at the direction of the Vice President; works to meet strategic goals and targets 3. Leads implementation of policies and regulations in compliance with all federal, state and institutional requirements. 4. Educates the research community MGB research policies, federal regulatory requirements, state requirements, accreditation standards and ethical approaches to ensure appropriate conduct of human subject research. Works collaboratively with investigators to balance compliance requirements while supporting the ethical conduct of research. 5. Communicates as needed with federal and state regulatory agencies, such as the Food and Drug Administration (FDA), the National Institutes of Health (NIH), the Office for Human Research Protections (OHRP), and the Massachusetts Department of Public Health on matters relating to human subject protections and reporting requirements. 6. Coordinates, as needed, and participates in regulatory agency site visits and audits; analyzes and assesses audit findings and proposes and implements changes to IRB policies and procedures to address findings, when needed. 7. Establishes and maintains a culture of excellence, inclusion, high trust, high performance, teamwork, and superior customer service amongst staff. 8. Hires, supervises and develops Associate and Assistant Directors, and Management staff in support of key HRO operations. 9. Conducts regular meetings of direct reports and HRO office. 10. Prepares and oversees HRA budget, organizational structure and function of HRO. 11. Interprets relevant state and federal regulations; develops and/or revises institutional policies and procedures, as needed, to assure compliance with applicable laws and regulations. 12. Develops and analyzes key operational and performance metrics to measure progress against goals and targets and identifies opportunities for improvement. Aligns metrics to industry best practices and keeps review timelines consistent with national metrics. Distributes reports to senior leadership on a regular basis and upon request. 13. Leads team in developing updates to the IRB electronic data management system to support the efficient submission and review of research applications, including development of business requirements, user acceptance testing, and training for IRB staff and the research community 14. Maintains Association of Accreditation of Human Research Protection Programs (AAHRPP) accreditation including overseeing preparation and timely submission of AAHRPP accreditation application and annual reports and preparation for and conduct of accreditation site visits. 15. Conducts other activities/projects at the direction of the HRA Vice President.
Qualifications Masters degree in related field required Extensive working knowledge of federal regulations that pertain to human subjects research Knowledge of AAHRPP standards and accreditation requirements Knowledge of HIPAA regulations Demonstrated experience developing and implementing training and education in human subject research. Practiced negotiator and creative problem solver; adept at conflict resolution. Prior experience working with independent IRBs and with single IRB models preferred Minimum of 10 years human subjects research leadership experience Minimum of 5 years of management experience with budget responsibility Experience working in an academic medical center IRB office strongly desired Skills Required Excellent communication skills – both oral and written Ability to clearly and effectively communicate to individuals at all levels, including junior research staff, senior researchers (senior faculty members, research leadership), IRB members. Demonstrated leadership, delegation and mentoring skills to effectively manage and develop staff members. Excellent project management skills Excellent analytical skills and critical thinking Excellent organizational skills, ability to pay close attention to detail Adept at making data driven decisions Ability to treat confidential information with utmost discretion Ability to multi-task and prioritize in a fast-paced environment Ability to work effectively in a collaborative manner with all departmental faculty and staff, as well as other institutional representatives Ability to work with IRB data management systems Certified IRB Professional (CIP) required.
Working Conditions Standard office environment – office, currently 100% remote during pandemic.
Telecommuting is allowed.
Internal Number: 3129330
About Mass General Brigham
As a not-for-profit organization, Mass General Brigham is committed to supporting patient care, research, teaching, and service to the community by leading innovation across our system. Founded by Brigham and Women’s Hospital and Massachusetts General Hospital, Mass General Brigham supports a complete continuum of care including community and specialty hospitals, a managed care organization, a physician network, community health centers, home care and other health-related entities. Several of our hospitals are teaching affiliates of Harvard Medical School, and our system is a national leader in biomedical research.
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