Full Board Specialist

Site: Mass General Brigham Incorporated

Mass General Brigham relies on a wide range of professionals including doctors nurses business people tech experts researchers and systems analysts to advance our mission. As a not-for-profit we support patient care research teaching and community service striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.

Job 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 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
(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 and the vote on these actions
(1) the number of members voting for against and abstaining
(2) the basis for requiring changes in or disapproving of the research
(3) summary of the discussion of controverted issues and their resolution
(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

Education

• Bachelors degree required; Masters degree strongly preferred

Licenses and Certifications

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

Work Experience

• At least 3-5 years of related research or regulatory affairs experience required
• At least 3-5 years of knowledge of federal state and local laws and regulations governing human-subjects research preferred

Working Conditions

• This is a full-time remote role that can be done from most US states
• There is an expectation that youd work to 6 PM or 7 PM ET Tuesday/Wednesday nights occasionally to lead IRB meetings

Remote

399 Revolution Drive

40

Regular

Day (United States of America)

Pay Range

$63252.80 - $102596.00/Annual

Grade

7

At Mass General Brigham we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive and any offer extended will take into account your skills relevant experience if applicable education certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however it does not encompass all elements contributing to your total compensation addition to competitive base pay we offer comprehensive benefits career advancement opportunities differentials premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.

0100 Mass General Brigham Incorporated is an Equal Opportunity Employer. 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. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973 the Vietnam Veterans Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990 applicants who require accommodation in the job application process may contact Human Resources at .

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