Full Board Specialist at Partner's Healthcare in Somerville, Massachusetts

Job Description:

Site: Mass General Brigham Incorporated


At Mass General Brigham, we know it takes a surprising range of talented professionals to advance our mission-from doctors, nurses, business people and tech experts, to dedicated researchers and systems analysts. As a not-for-profit organization, Mass General Brigham is committed to supporting patient care, research, teaching, and service to the community. We place great value on being a diverse, equitable and inclusive organization as we aim to reflect the diversity of the patients we serve.


At Mass General Brigham, we believe a diverse set of backgrounds and lived experiences makes us stronger by challenging our assumptions with new perspectives that can drive revolutionary discoveries in medical innovations in research and patient care. Therefore, we invite and welcome applicants from traditionally underrepresented groups in healthcare - people of color, people with disabilities, LGBTQ community, and/or gender expansive, first and second-generation immigrants, veterans, and people from different socioeconomic backgrounds - to apply.



Job Summary
General Overview


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 submission and 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
14. Assumes additional responsibilities as assigned by the Assistant Director.



Qualifications

• 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.


• Knowledge of federal, state, and local laws and regulations governing human-subjects research.


• Certified IRB professional (CIP) credential in good standing (or must pass certification exam within first 90 days of employment).

Additional Job Details (if applicable)



Remote Type


Remote



Work Location


399 Revolution Drive



Scheduled Weekly Hours


40



Employee Type


Regular



Work Shift


Day (United States of America)



EEO Statement:


Mass General Brigham Incorporated 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. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.




Mass General Brigham Competency Framework



At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline. Apply Now