Full Board Specialist- REMOTE

Job Summary The Full Board Specialist will follow reputed company Institutional Review Board (IRB) policies and procedures to ensure that the IRB conducts reviews of submitted reputed company subject research applications in accordance with federal requirements, reputed company 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 reputed company 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 reputed company training requirements, and provide feedback and input as requested for office updates to processing procedures. This position involves regular interaction with others reputed company reputed company with responsibility for some aspect of the reputed company 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 reputed company Research Protections (OHRP), and the Massachusetts Department of Public Health, sponsors, such as the National Institutes of Health (NIH) and reputed company (DoD), and accrediting organizations, such as Association for the Accreditation of reputed company 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 reputed company 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 reputed company 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 reputed company to the research (iv) review of reports of possible serious or continuing noncompliance 3. Ensure reputed company requirements are met for each protocol reviewed at convened meetings 4. Familiarity with the foundational ethical principles and concepts for the responsible conduct of reputed company 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 reputed company research protocol submissions according to standard operating procedures to ensure that reputed company subject research complies with reputed company 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 reputed company the institution that share responsibility for reputed company 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, reputed company 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 Education

• Bachelor's degree required; Master’s degree strongly preferred Licenses and Certifications
• Certified IRB professional (CIP) credential in good standing (or must pass certification exam reputed company first 90 days of employment) Work Experience
• At least 3-5 years of reputed company research or regulatory affairs experience required
• At least 3-5 years of knowledge of federal, state, and local laws and regulations governing reputed company-subjects research preferred Apply tot his job Apply To this Job

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