IRB Education & Quality Improvement Program Manager

• Manages and oversees the Education and Quality Improvement Program (EQuIP) to ensure institutional compliance with federal regulations, state laws and (BCH) policies
• Oversees and participates in the planning, organization, and conduct of audits to evaluate whether the Institutional Review Board (IRB) and investigators adequately adheres to relevant regulations and institutional policies governing the review of human subject research.
• Oversees and participates in the planning, organization and conduct of for-cause audits of a specific protocol and/or investigator as requested by the IRB, Department Chair/Chief or Institutional Official to address a Human research protection specific concern, question, issue, or non-compliance
• Maintains, develop and update polices, procedures and guidance document
• Assists IRB in evaluating whether the IRB adequately addresses applicable ethical and compliance standards
• Develops data, metrics and benchmarks assuring compliance with IRB regulations
• Assists in the preparation of accreditation application, the conduct of site visits and any associated responses and oversight of corrective actions
• Collaborates with other departments to determine ways to more effectively implement human subject protections at an institutional level
• Collaborates with Clinical Research Operations as needed for potential audits, QI efforts and discussions of policy and procedures related to human subject protection and clinical research operations
• Delegate responsibilities and supervises the activities of EQuIP staff member(s) Sr. IRB QI Consultant
• Collaborates, develops and participates in specialized projects and institutional efforts intended to promote the protection of human subjects in clinical research.
• Analyzes data from audits and prepares reports for the Director of Clinical Research Compliance and Vice President of Research Administration which includes findings and suggestions for human subject and IRB compliance improvements.
• Directs, oversees, collaborates and participates in the implementation educational training programs for IRB members. IRB staff, the research community in human subject protection regulations and IRB policies. This includes webinars and newsletters for IRB members and the research community
• Oversees and participates in the development of benchmarks and best practices for compliance with human subject protection regulations and policies.

Requirements:

• Master’s Degree in Life sciences, nursing, pharmacy or a closely related field.
• Minimum of 4 years’ experience in clinical research. Experience as a research nurse, research coordinator or clinical trials monitor necessary
• An understanding in the interpretation of Department of Health and Human services and FDA regulations and experience in clinical research monitoring and data management analytic methods in a health care setting necessary.
• Knowledge of theories, principles, standards, and techniques involving the art of auditing and of the methods of interviewing, compiling and analyzing information, and have the ability to write clear concise audit reports.
• Experience in establishing quality improvement benchmarks and metrics desirable

Boston Children’s Hospital offers competitive compensation and unmatched benefits including flexible schedules, affordable health, vision and dental insurance, child care and student loan subsidies, generous levels of time off, 403(b) Retirement Savings plan, Pension, Tuition and certain License and Certification Reimbursement, cell phone plan discounts and discounted rates on T-passes. Experience the benefits of passion and teamwork.

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