The Expedited Specialist I will conduct reviews of submitted human subject research applications in accordance with federal requirements, Human Research Office (HRO) policies and procedures and accreditation standards. Under the direction of the Assistant Director, the Expedited Specialist I will work with personnel in all areas of the submission and review process to ensure appropriate screening and review of research documents, and provide support to research staff on research submissions, training requirements, and updated processing procedures.
The Expedited Specialist I is designated by the Mass General Brigham Institutional Review Board (IRB) Chair to review, require modifications to, and approve research designated by the federal regulations as eligible for expedited review for limited types of applications. The Expedited Specialist I is also responsible for determining when an activity meets the definition of human subject research under federal regulations and determine when research is exempt under the federal regulations. The Expedited Specialist I 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 regional and national conferences and educational events
QUALIFICATIONS: 1. Bachelor's degree required; in medically related area preferred with at least 1-3 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. Ability to obtain Certified IRB Professional (CIP) 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 participate effectively in meetings, both formal and informal 7. Self-motivated, independent and possesses the ability to learn quickly 8. Ability to proficiently utilize electronic tools and resources for remote work
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.
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. Mass General Brigham 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 Mass General Brigham 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.