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 Women's 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.
We're focused on a people-first culture for our system's patients and our professional family. That's 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 development-and 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.
General Summary: Under the general direction of the Assistant Director, the Expedited Specialist is charged with conducting selected reviews of human subjects protocols in accordance with federal, state, and local laws and regulations, MGB Human Research Policies and Procedures, and the ethical principles described in the Belmont Report. The Expedited Specialist is designated by the MGB Institutional Review Board (IRB) Chair to review research and (1) make exemption determinations; (2) approve and conduct continuing review of non-exempt minimal risk research using the expedited review procedures; (3) approve minor changes in approved research; and (4) review unanticipated problems involving risks to subjects or others that are not serious. The Expedited Specialist is also responsible for determining when an activity meets the definition of human subject research under federal regulations. The Expedited Specialist works with others, as appropriate, on the development of or updates to MGB policies and procedures. This position involves regular interaction with others within the MGB system with responsibility for some aspect of the human research protection program.
Principal Duties and Responsibilities:
1. Act as a member of the MGB IRB and expedited reviewer as designated by the MGB IRB Chair 2. Work independently to review research activity submitted to the MGB IRB to
a. determine research is not human subjects research or a clinical investigation subject to IRB review; b. determine if research meets exemption criteria c. approve non-exempt minimal risk research using the expedited review procedure d. approve minor changes in approved research e. conduct continuing review of approved minimal risk research f. review other events. 3. Review human research protocol submissions according to standard operating procedures to ensure that human subject research overseen by the MGB IRB complies with all applicable federal, state and local regulations as well as institutional policies and procedures and guidelines. 4. 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. 5. Identify 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. 6. Work with the research community in a collaborative manner to provide guidance and consultation to investigators and clinical research personnel about the MGB IRB policies and procedures and changes needed to secure IRB approval of submitted protocols. 7. Adhere to turnaround times for review and processing activities; identify opportunities for improvement; participate in process improvement activities; implement requested changes. 8. Attend IRB meetings and act as voting member as needed 9. With Assistant Director and others, develop and implement new policies, procedures and educational information as needed; 10. Participate in the development and implementation of educational workshops and activities for the research community. 11. Participate in regional and national conferences and educational events
Bachelor's degree required; Master's degree in medically-related area preferred (Nurse Practitioner, Physician's Assistant) with at least 3 years of relevant experience in clinical research or regulatory affairs.
Knowledge of federal, state, and local laws and regulations governing human subjects research.
Ability to obtain Certified IRB Professional (CIP) certification when eligible.
Excellent oral and written communication skills
Excellent organizational skills with ability to prioritize work and adhere to office timelines
Ability to assess institutional and federal criteria, apply to a variety of situations, and make decisions based on specified criteria
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
Ability to problem solve and successfully negotiate and collaborate with others of different skill sets, backgrounds and levels within and external to the organization
Ability to effectively conduct meetings, both formal and informal and to facilitate large working sessions with all levels of staff
Self-motivated, independent and possesses the ability to learn quickly
Working Conditions: Standard office environment with possible local travel to Partners sites
Fiscal Responsibility: Demonstrates fiscal responsibility by effectively using MGB resources
EEO Statement Partners HealthCare is an Equal Opportunity Employer & by embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. Partners Healthcare System Inc. is acting as an Employment Agency in relation to this vacancy.
MGH Institute of Health Professions, founded by Massachusetts General Hospital in 1977, is an innovative and independent graduate school in Boston that is a member of Partners HealthCare. A progressive leader in developing comprehensive models of health care education, the MGH Institute prepares advanced practice professionals in the fields of nursing, physical therapy, occupational therapy and communication sciences and disorders through a distinctive combination of academic study, clinical practice, and research. More than 1,200 students are enrolled in graduate level and certificate programs, with an increasing number of courses available online. The Institute is accredited by the New England Association of Schools and Colleges (NEASC).