Columbia University · 3 months ago
Associate Vice President for Human Research Protection
Columbia University is a premier academic research institution seeking an Associate Vice President for Human Research Protection. The AVP will oversee the Human Research Protection Program, manage the Human Research Protection Office and its Institutional Review Boards, and ensure compliance with regulations while fostering a culture of ethical research.
EducationHigher EducationMedicalTrainingUniversities
Responsibilities
Lead, develop, and execute the strategic vision for the HRPP, in alignment with Columbia’s research mission and compliance framework
Collaborate closely with academic, clinical, and research leaders to promote a culture of ethical research
Act as primary institutional representative to regulatory agencies, such as OHRP and FDA, and accreditation bodies like AAHRPP
Direct the operations of the HRPO and IRBs, overseeing 6 boards across biomedical and social-behavioral domains
Manage HRPO staffing, budgeting, and professional development
Supervise IRB protocol review teams to ensure efficient, consistent and high-quality reviews
Manage the finances including the procedures for collection of IRB review fees
Ensure that human subjects research at the University adheres to all federal, state and local laws and regulations and to relevant University policies and procedures
Oversees HIPAA Privacy Board functions and implement policies related to reliance agreements and single IRB review
Maintains accreditation of the HRPP by the Association for the Accreditation of Human Research Protection Programs or other organizations through annual reports and five year reaccreditation process
Oversees the HRPO Compliance Oversight Team, including conducting for cause and not for cause audits
Act as the primary liaison with investigators and research staff with respect to significant matters relating to the protection of human subjects
Collaborate with the Irving Institute for Clinical and Translational Research to facilitate initiatives to streamline the process of initiating new human research at CUIMC
Provides regular reports and makes recommendations to senior management with respect to issues requiring an institutional response
Consult with senior management on IRB membership selection
Develop and implement an institutional training program on human subjects research
Coordinates strategic planning for the HRPP
Develop and report key performance metrics related to HRPP efficiency, quality and compliance
Guide continuous improvement initiatives through process evaluation and stakeholder feedback
Qualification
Required
Bachelor's degree in a relevant field with a strong preference for an advanced degree
At least 7 years of relevant experience in human research protection programs
Advanced level of understanding of operational requirements relating to the management and implementation of a HRPP
Deep and current knowledge regarding federal, state and local human subjects research regulations
Excellent organizational skills and independent decision making ability
Demonstrated experience leading successful organizational transformation to achieve operational efficiencies and increased client service
Demonstrated ability to build and motivate a high performing team
Excellent interpersonal, management and organizational skills
Preferred
Certified IRB Professional (CIP) or equivalent strongly preferred
Company
Columbia University
Columbia University is a research institution and Ivy League school for undergraduate and graduate students across various fields
Funding
Current Stage
Late StageTotal Funding
$21.84MKey Investors
ValeNational Institutes of HealthNational Science Foundation
2024-09-24Grant· $0.02M
2023-08-17Grant
2023-05-04Grant· $20M
Leadership Team
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