The Human Research Protection Program (HRPP) is seeking an experienced and innovative Project Manager to manage the IRB of record (IoR) responsibilities within the HRPP Operations Office. An IoR is the IRB responsible for the review and oversight of human subjects research. Federal regulations and institutional initiatives require MSK IRBs to serve as the IoR for outside sites participating in a research study and for some research studies to cede IRB review to an outside entity. Join us today and help make a difference every day!

• A strong project manager with the ability to create project plans and communicate with various internal and external stakeholders.
• An excellent communicator that will be able to explain, interpret, share and present information on IRB of Record related projects to investigators, staff, and appropriate external contacts.
• Excellent at time management, especially when involved with simultaneous management of multiple projects.

• Serve as a liaison to investigators and research staff for human subjects protections and regulatory compliance providing guidance and troubleshooting issues.
• Review reliance agreements and local context forms to ensure they meet MSK standards.
• Work with outside entities as central contact for IoR correspondence.
• Keep informed of new and changing IoR regulation and adjust workflows and policies as needed.
• Create and upkeep HRPP Office templates and Clinical Research Portal pages as related to IoR items.
• Have in-depth knowledge of the processes/procedures associated with clinical research.
• Maintain, develop and implement methods and tools by which to organize, standardize and manage project activities.

• Knowledge of State and Federal HHS regulations regarding human subjects protection (45 CFR 46), the HIPAA Privacy Rule (45CFR 160,164), the FDA (21 CFR 50, 21 CFR 56).
• Experience with database management.
• Ability to solve problems by using a logical, systematic, sequential approach.
• Excellent interpersonal, verbal and written communication skills.
• Strong organizational, prioritization, and project management skills.

We believe in communication, openness, and thinking beyond your 8-hour day @ MSK. Its important to us that you have a sense of impact, community, and work/life balance to be and feel your best!

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