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Role Description

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.

• Screen protocol documents and application forms.
• Verify FDA documentation.
• Ensure submissions are accurate and complete prior to being scheduled for full board review.
• Oversee full board IRB meeting procedures, including pre-meeting communication with Chairs and members.
• Document complete meeting minutes in accordance with federal requirements and policies.
• Provide support to research staff on research submissions.
• Complete all training requirements.
• Provide feedback and input for office updates to processing procedures.
• Interact with federal and state regulatory agencies, sponsors, and accrediting organizations as needed.

Qualifications

• Bachelor's degree required; Master’s degree strongly preferred.
• Certified IRB professional (CIP) credential in good standing (or must pass certification exam within first 90 days of employment).
• 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.

Requirements

• Serve as a liaison and information resource to investigators and research personnel.
• Attend convened meetings for initial and continuing review of research activities involving human subjects.
• Ensure quorum requirements are met for each protocol reviewed at convened meetings.
• Familiarity with foundational ethical principles for the responsible conduct of human subjects research.
• Compose minutes of IRB meetings, including attendance, actions taken, and vote results.
• Review and confirm that required modifications have been sufficiently addressed prior to IRB approval.
• Review human research protocol submissions according to standard operating procedures.
• Compose correspondence to investigators articulating modifications required for IRB approval.
• Communicate with relevant research ancillary committees and hospital departmental leadership.
• Work collaboratively with the research community to provide guidance on IRB policies and procedures.
• Meet turnaround times for review and processing activities.
• Develop and implement new policies, procedures, and educational information as needed.
• Participate in regional and national conferences and educational events.
• Assume additional responsibilities as assigned by the Assistant Director.

Benefits

• Comprehensive benefits package.
• Career advancement opportunities.
• Differentials, premiums, and bonuses as applicable.
• Recognition programs designed to celebrate contributions and support professional growth.