IRB Manager - Remote Position in New York, NY for Icahn School of Medicine at Mount Sinai (2024)

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Internal Number: Req ID 3017268

Responsible for oversight of the administrative, operational and financial activities in the PPHS office. Ensures the successful coordination and delivery of the day-to-day operations, which may include budgetary oversight, staffing and administration of policies and procedures.

Remote work position

Responsibilities

• Understands and applies the Federal Regulations for human research to all project applications submitted for category determination and each level of IRB review (pre-review, re-review, clarifying issues, post meeting, Non-committee review) to ensure adherence to regulatory and ethical standards.
• Manages and supervises staff
• Oversees and recommends hiring/termination of employees and participate in these processes;
• Conducts QA assessments of work outcomes; conduct performance evaluations, manage PTO and other administrative human resource tasks as assigned
• Ensures mentorship and disciplinary action when warranted
• Manage orientation, training and continuing education of staff
• Provides metrics reports on a regular basis
• Assists with development, implementation, and continued oversight of automated research administration system.
• Analyzes internal processes and plans or implements procedural and policy changes to improve operations.
• Ensures that IRB documentation and records are in accordance with requirements and ensure that all records are secured and properly archived.
• Coordinate SOP implementation among departmental staff and strategize on implementation measures where the research community is impacted.
• Manages the assignment and distribution of analysts work
• Manages assessment of weekly analyst review metrics and reports to Leadership.
• Reviews the quality level of project reviews by analysts and assists in resolving related issues including acting as a liaison between the PPHS and the research community.
• Perform non-committee reviews (NCR) for project submissions as needed, when needed, review submissions independently
• Oversee staff reviews and correspondence for quality, completeness, and regulatory compliance
• Facilities QA of computerized database usage
• Assists with PPHS Regulatory Affairs division on QA/QI auditing
• Serve as a resource for investigators on general regulatory information and facilitate communication between investigators and the IRB
• Provides guidance to the research community about policies and procedures
• Assist investigators and coordinators in development of research proposals
• Manage institutional education courses for the research community
• Coordinate attendance at educational conferences and meetings and subsequent reports back to the PPHS office
• Performs other related duties.
• Required to be in at Mount Sinai Health System once a year at your expense to meet HR requirements of remote work.

• Bachelors degree in business or public administration or related field, Masters preferred
• 7+ years experience in an administrative or management capacity, including 4 years in an Institutional Review Board environment
• IRB Member appointment
• Certified IRB Professional Certification (CIP)
• MS Office skills