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Posted: 10-May-23
Location: Somerville, Massachusetts
Type: Full Time
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Internal Number: 3245115
The Expedited Specialist II 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 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 II independently understands and applies the federal and state regulations for human subjects research to studies submitted for category determination to ensure adherence to regulatory and ethical standards. The responsibilities of this position also include assisting the Assistant Director with educational initiatives (e.g., presentations to research community, HRO staff), providing regulatory consults for the research community, contributions to and participation in IRB initiatives, process improvement and HRO optimization goals.
The Expedited Specialist II is designated by the MGB Institutional Review Board (IRB) Chair to review, require modifications to, and approve research designated by the federal regulations as eligible for expedited review across all types of applications. The Expedited Specialist II 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 II 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.
- Act as a member of the MGB IRB and expedited reviewer as designated by the MGB IRB Chair
- Work independently to review research activity submitted to the MGB IRB to
- determine research is not human subjects research or a clinical investigation subject to IRB review;
- determine if research meets exemption criteria
- approve non-exempt minimal risk research using the expedited review procedure
- approve minor changes in approved research
- conduct continuing review of approved minimal risk research
- review other events.
- 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.
- 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.
- 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.
- 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.
- Adhere to turnaround times for review and processing activities; identify opportunities for improvement; participate in process improvement activities; implement requested changes.
- Attend IRB meetings and act as voting member as needed
- With Assistant Director and others, develop and implement new policies, procedures and educational information as needed.
- Work with Assistant Director and others to develop and present educational initiatives for the research community on applicable HRO policies, procedures, federal and state regulations and ethical principles.
- Participate in the development and implementation of educational workshops and activities for the research community.
- Provide one-on-one ethical and regulatory consultation to Principal Investigators and research teams regarding submission of IRB applications and conduct of research.
- Participate in regional and national conferences and educational events
- Assumes additional responsibilities as assigned by the Assistant Director.
- 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 IRB, clinical research and/or regulatory affairs.
- Knowledge of federal, state, and local laws and regulations governing human subjects research.
- Certified IRB Professional (CIP) certification required.
