Associate Vice President for Human Research Protection

Position Summary

The Associate Vice President for Human Research Protection (the "AVP") is the senior officer responsible for the oversight of Columbia's Human Research Protection Program (HRPP) and the administration and management of Columbia's Human Research Protection Office (HRPO) and its Institutional Review Boards (collectively, the IRB). Working with the Chairs of Columbia's IRB Boards, the AVP is charged with overseeing the protection of human participants in research studies and ensuring the proper review and approval of research protocols involving human subjects. Currently, Columbia has six IRB Boards that cover biomedical, social science-behavioral and other research conducted by Columbia researchers at Columbia University Irving Medical Center (CUIMC), on the Morningside Heights, Lamont-Doherty Earth Observatory and Nevis campuses, and at other domestic and international sites.

The AVP reports to the Vice President for Research Operations and Policy in the Office of the Executive Vice President for Research, and works in close coordination with the Office of the Dean in the Vagelos College of Physicians and Surgeons at CUIMC. As the Columbia IRB is also the IRB of record for NewYork-Presbyterian Hospital (NYPH), the AVP also interacts with senior management at NYPH.

The successful candidate will advance operational excellence by optimizing IRB and HRPP workflow efficiency and ensuring consistency across all review boards. They will maintain and elevate compliance standards by leading successful re-accreditation cycles and ensuring the program remains responsive to evolving regulations. With a focus on enhancing the researcher experience, this role will develop service-oriented policies and training that both facilitate high-quality research and uphold compliance. The candidate will foster a culture of ethics and integrity by serving as a visible champion for human research protections across the Columbia enterprise. In addition, they will drive innovation and technology adoption, leveraging systems and tools to streamline processes.

This is a highly visible leadership role that offers the opportunity to shape policy, strengthen compliance, and foster a culture of ethical research at one of the world's premier academic research institutions.

This position is hybrid, with the opportunity to work remotely part of the time while maintaining an on-site presence.

Responsibilities

Strategic Leadership and Governance

• 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.

Program Oversight and Operational Management

• 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.

Compliance, Policy and Accreditation

• 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.

Education, Training and Researcher Engagement

• 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.
• Providesregular 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.

Metrics, Evaluation, and Continuous Improvement

• Develop and report key performance metrics related to HRPP efficiency, quality and compliance.
• Guide continuous improvement initiatives through process evaluation and stakeholder feedback.

Minimum Qualifications

* 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.
* Certified IRB Professional (CIP) or equivalent strongly preferred.
* 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.

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.