High quality Review & Monitoring for research studies is a critical standard for the Center to ensure competitiveness and scientific integrity in the industry. We are seeking a Protocol Review Manager to join our Protocol Activation and Human Research Protection Program Unit . As a critical member of the team within Clinical Research Administration and in compliance with all regulatory, institutional, and departmental requirements, the Protocol Review Manager provides day-to-day management and coordination to MSKs institutional and departmental protocol review committee activities to support the achievement of Center goals for Time to Activation. This position will work closely with institutional committees such as a Pediatric-specific DSMC and Research Council, MSKs scientific review committee.
Serve as main point of contact for Protocol Review Committees. Handle all aspects of Protocol Review Committees to ensure efficiency and adherence to each Committees mission and CCSG guidelines.
Work closely with all members of Protocol Review Core in optimizing processes and structuring review workflows for all departmental and institutional committees.
Demonstrate technical expertise in protocol review and monitoring and the federal/regulatory guidelines as it applies to clinical research at MSKCC.
Provide timely instruction and guidance to investigators and research staff across the organization on protocol review and approval process, protocol monitoring, including system support with the Protocol Information Management System (PIMS).
Capable of anticipating and balancing the needs of multiple stakeholders.
A good decision-maker, with proven success at making timely decisions that keep the organization moving forward.
An effective communicator, capable of determining how best to reach different audiences and executing communications based on that understanding.
Adept at building partnerships and working collaboratively with others to meet shared objectives and goals.
Bachelors degree with at least 4 years of Clinical Research/Project Management experience.
Human Subjects Protection, GCP and GMP standards, FDA/EMA requirements, Quality Standards and Systems experience.
Excellent collaboration and team building skills.
Ability to build strong customer relationships.
Ability to drive multiple projects to successful completion.
Demonstrated written communication skills - The ability to develop, facilitate, and orchestrate effective communication with all members of MSK; responsible for the writing, preparing and educating staff on clinical research procedures and processes. Individual must be able to communicate effectively with all levels of staff including clinical staff (investigators, nurses etc), administration, research and clerical support staff, and Institutional Leaders as well as external sponsors. Excellent oral and written communication skills are required.
Experience in a regulated environment - Must have an advanced comprehensive knowledge and understanding of the regulations pertaining to human research protection (including 21 CFR and 45 CFR 46 of the United States Code of Federal Regulations) and Health Insurance Portability and Accountability Act (HIPAA).
At Memorial Sloan Kettering (MSK), we’re not only changing the way we treat cancer, but also the way the world thinks about it. By working together and pushing forward with innovation and discovery, we’re driving excellence and improving outcomes. For the 28th year, MSK has been named a top hospital for cancer by U.S. News & World Report. We are proud to be on Becker’s Healthcare list as one of the 150 Great Places to Work in Healthcare in 2018, as well as one of Glassdoor’s Employees’ Choice Best Place to Work for 2018. We’re treating cancer, one patient at a time. Join us and make a difference every day.