Associate Chair 9/19/2017
JOB DESCRIPTIONAPPLY As a not-for-profit organization, Partners HealthCare is committed to supporting patient care, research, teaching, and service to the community by leading innovation across our system. Founded by Brigham and Womens Hospital and Massachusetts General Hospital, Partners HealthCare 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.
Were focused on a people-first culture for our systems patients and our professional family. Thats why we provide our employees with more ways to achieve their potential. Partners HealthCare is committed to aligning our employees personal aspirations with projects that match their capabilities and creating a culture that empowers our managers to become trusted mentors. We support each member of our team to own their personal developmentand we recognize success at every step.
Our employees use the Partners HealthCare values to govern decisions, actions and behaviors. These values guide how we get our work done: Patients, Affordability, Accountability & Service Commitment, Decisiveness, Innovation & Thoughtful Risk, and how we treat each other: Diversity & Inclusion, Integrity & Respect, Learning, Continuous Improvement & Personal Growth, Teamwork & Collaboration.
Under the general direction of the Director, incumbent serves as Associate Chairperson of the Partners Human Research Committees (PHRC), the Institutional Review Board (IRBs) charged with the review of all research involving human subjects at Partners HealthCare affiliated institutions (MGH, BWH, McLean, SRN, etc.). As Associate Chairperson, incumbent is responsible for initial and continuing review of human-subjects research, and proposed changes in approved research as well as review of unanticipated problems involving risks to subjects or others in accordance with federal, state, and local laws and regulations, Partners Human Research Policies and Procedures, and the ethical principles described in the Belmont Report. Incumbent is authorized to review research and (1) make exemption determinations, (2) approve non-exempt minimal risk research using the expedited review procedure, (3) approve minor changes in approved research not otherwise eligible for expedited review, and (4) review unanticipated problems involving risks to subjects or others that are not serious. The Associate Chair works with others, as appropriate, on the development of or updates to Partners Human Research policies and procedures. This position involves regular interaction with others within the Partners system with responsibility for some aspect of the human research protection program. As needed, the Associate Chair 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
Associate Chairpersons are responsible for one or more of the following activities:
Expedited Review Activities
1. Determining whether a research activity submitted for PHRC review is human-subjects research or a clinical investigation subject to PHRC review,
2. Determining exemptions from 45 CFR 46,
3. Conducting expedited review of the following: (i) initial and continuing review of research activities, (ii) proposed minor changes in approved research during the period of PHRC approval, and (iii) unanticipated problems involving risks to subjects or others, including adverse events that are unexpected and related to the research, but are not serious,
Convened Meeting Activities
4. Attending or presiding as Chair at convened meetings of the PHRC during which the PHRC 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,
5. Reviewing and voting on human research protocol submissions on the agenda of convened meetings and ensuring quorum requirements are met for each protocol reviewed at convened meetings,
6. Composing minutes of PHRC meetings, to include attendance at meetings, actions taken by the PHRC, the vote on these actions, including: (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,
7. Reviewing modifications in research required by the PHRC at convened meetings to secure approval, and confirming that modifications have been made as required by the PHRC,
8. Overseeing membership to ensure that the PHRC continues to have members with the necessary experience and expertise to review the breadth of research conducted by Partners investigators,
9. Orienting new PHRC members and providing guidance to members on regulatory issues and institutional policies and procedures,
Expedited and Convened Meeting Activities
10. Reviewing human research protocol submissions to ensure that human subject research overseen by the PHRC complies with all applicable federal, state and local regulations as well as institutional policies and procedures and guidelines,
11. Composing letters 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,
12. Identifying requirement(s) for review by the ancillary committees, or communication or coordination with other departments, groups, or individuals within the institution that share responsibility for human subject protection,
13. Providing guidance to investigators and clinical research personnel to the PHRC policies and procedures,
14. Participating in the development and implementation of educational workshops and activities for the research community,
15. Participating with Directors and others on development of and updates to human research policies and procedures,
16. Working with the Directors and others to identify and resolve problems and formulate short- and long-term goals and objectives,
17. Keeping current on federal, state, local laws and regulations governing human-subject research and attending conferences, workshops, seminars, or lectures that pertain to human-subject protection.
18. Uses the Partners HealthCare values to govern decisions, actions and behaviors. These values guide how we get our work done: Patients, Affordability, Accountability & Service Commitment, Decisiveness, Innovation & Thoughtful Risk, and how we treat each other: Diversity & Inclusion, Integrity & Respect, Learning, Continuous Improvement & Personal Growth, Teamwork & Collaboration.
19. Other duties as assigned.
1. Medical Doctor (MD) or advanced degree in a biomedical science, social science, law or ethics discipline or regulatory field (e.g., PhD, ScD, EdD, DNP, MS, MSN, MSW, MPH, MPA, MSCI, PharmD, JD) and 2 years of relevant experience or other healthcare professional (e.g., BSN) with at least 5 years of relevant experience in clinical research or regulatory affairs.
2. Extensive knowledge of federal, state, and local laws