GENERAL SUMMARY: The Full Board Specialist will follow Mass General Brigham Institutional Review Board (IRB) policies and procedures to ensure that the IRB conducts reviews of submitted human subject research applications in accordance with federal requirements, Human Research Office (HRO) policies, and accreditation standards. Under the general direction of the Assistant Director, the Full Board Specialist will participate in the complete cycle of the submissionand review process to ensure comprehensive screening and Full Board review of greater than minimal risk human research applications. Specifically, the Full Board Specialist will be responsible for screening protocol documents and application forms, verifying FDA documentation, and ensuring submissions are accurate and complete prior to being scheduled for full board review. The Full Board Specialist is also responsible for overseeing full board IRB meeting procedures, including pre-meeting communication with Chairs and members as well as post- meeting documentation of the complete meeting minutes in accordance with federal requirements and policies and procedures. The Full Board Specialist is expected to provide support to research staff on research submissions, complete all training requirements, and provide feedback and input as requested for office updates to processing procedures
This position involves regular interaction with others within Mass General Brigham with responsibility for some aspect of the human research protection program. As needed, the Full Board Specialist interacts 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, sponsors, such as the National Institutes of Health (NIH) and Department of Defense (DoD), and accrediting organizations, such as Association for the Accreditation of Human Research Protection Programs (AAHRPP).
PRINCIPAL DUTIES AND RESPONSIBILITIES:
1. Serve as a liaison and information resource to investigators and research personnel by advising them on all federal requirements and policies for approval of research with humans. 2. Attend convened meetings during which the IRB conducts: (i) initial and continuing review of research activities involving human subjects; (ii) review of proposed changes in approved research during the period of approval that are not minor; (iii) review of unanticipated problems involving risks to subjects or others, including adverse events that are serious, unexpected and related to the research; and (iv) review of reports of possible serious or continuing noncompliance; 3. Ensure quorum requirements are met for each protocol reviewed at convened meetings; 4. Familiarity with the foundational ethical principles and concepts for the responsible conduct of human subjects research (i.e. The Belmont Report, Nuremberg Code, etc) 5. Compose minutes of IRB meetings, to include attendance at meetings; actions taken by the IRB; the vote on these actions, i.e., : (1) the number of members voting for, against, and abstaining; (2) the basis for requiring changes in or disapproving the research; (3) summary of the discussion of controverted issues and their resolution; and (4) findings and determinations required by regulation. 6. Review and confirm that required modifications have been sufficiently addressed prior to IRB approval. 7. Review human research protocol submissions according to standard operating procedures to ensure that human subject research complies with all applicable federal, state and local regulations as well as institutional policies and procedures and guidelines. 8. Compose correspondence to investigators articulating modifications required in the research to secure IRB approval and any questions, concerns, or clarifications that need to be addressed before IRB approval can be considered. 9. Communicate as appropriate with the relevant research ancillary committees, hospital departmental leadership, groups, or individuals within the institution that share responsibility for human subject protection; 10. Work with the research community in a collaborative manner to provide guidance and consultation to investigators and clinical research personnel about the IRB policies and procedures and changes needed to secure IRB approval of submitted protocols. 11. Meet turnaround times for review and processing activities; identify opportunities for improvement; participate in process improvement activities; implement requested changes. 12. With Assistant Director and others, develop and implement new policies, procedures and educational information as needed. 13. Participate in regional and national conferences and educational events
QUALIFICATIONS: 1. Bachelor's degree required; Master’s (or doctoral) degree in healthcare-related area strongly preferred (e.g. Master of Public Health, Master of Science, Nurse Practitioner, Physician’s Assistant) with at least 3 years of relevant experience in clinical research or regulatory affairs. 2. Knowledge of federal, state, and local laws and regulations governing human-subjects research. 3. Certified IRB professional (CIP) credential in good standing (or ability to obtain certification when eligible).
SKILLS/ ABILITIES/ COMPETENCIES REQUIRED: 1. Excellent oral and written communication skills 2. Excellent organizational skills with ability to prioritize work and adhere to office timelines 3. Ability to assess institutional and federal criteria, apply to a variety of situations, and make decisions based on specified criteria. 4. Excellent interpersonal skills to effectively communicate with cross functional teams including staff at all levels of the organization, and both scientific/medical and non-scientific/medical personnel 5. Ability to problem solve and successfully negotiate and collaborate with others of different skill sets, backgrounds and levels within and external to the organization 6. Ability to effectively conduct meetings, both formal and informal, and to lead and facilitate large working sessions with all levels of staff. 7. Self-motivated, independent and possesses the ability to learn quickly.
WORKING CONDITIONS: Remote position with possible occasional travel to Mass General Brigham for office-wide meetings or retreats.
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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