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Columbia University Irving Medical Center · 2 months ago

Associate Vice President for Human Research Protection

New York, NY

Full-time

Hybrid

Director/Executive

$250K/yr - $300K/yr

7+ years exp

Columbia University Irving Medical Center is seeking an Associate Vice President for Human Research Protection to oversee the Human Research Protection Program and its Institutional Review Boards. The role involves ensuring compliance with research protocols, optimizing workflow efficiency, and fostering a culture of ethical research across the institution.

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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

Human Research ProtectionIRB ManagementCompliance StandardsOperational ManagementCertified IRB ProfessionalFederal Regulations KnowledgeOrganizational SkillsInterpersonal SkillsTeam Leadership

Required

Bachelor's degree in a relevant field

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

Advanced degree

Certified IRB Professional (CIP) or equivalent strongly preferred

Company

Columbia University Irving Medical Center

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Columbia University Irving Medical Center is a clinical and educational enterprise that offers medical, dental, and nursing services. It is a sub-organization of Columbia University.

Founded in 1767

New York, New York, USA

10001+ employees