Regulatory Research Associate - Protocol Activation
As an integral member of the research team and in compliance with all regulatory, institutional, and departmental requirements, the RRA performs all tasks associated with the regulatory management of research protocols within MSKCC. The RRA will be responsible for ensuring MSK is audit-ready at all times by maintaining up-to-date regulatory documents and regulatory files. The RRA also ensures the proper conduct of clinical research by developing, revising and maintaining accurate protocol tools at all times.
Work closely with the Operations and Compliance departments to ensure all activation-specific aspects of regulatory oversight are carried out for trials in the Protocol Activation Core.
Assist in development of protocol tools required for trial activation
Communicate with staff at all levels (principal investigators, clinical and research support staff), Clinical Research Organizations, and study Sponsors
Ensure that workflow is controlled and meets departmental needs.
Manages ongoing departmental projects and crafts processes to ensure that goals are met.
Participate in special projects and task forces as determined by management.
Generate reports to all necessary parties on the progress of the protocol, as needed.
Provide leadership, organizational, creative, or clerical support to established and new research initiatives.
A good decision-maker, with proven success at making timely decisions that keep the organization moving forward.
Able to hold yourself and others accountable in order to achieve goals and live up to commitments.
Flexible in your approach and demeanor in order to align with the shifting demands of evolving circumstances.
Knowledgeable of the regulations pertaining to human subject protection (including 21 CFR and 45 CFR 46 of the United States Code of Federal Regulations) and Health Insurance Portability and Accountability Act (HIPAA).
A minimum of a High School Diploma with experience in clinical research or applicable experience.
Bachelors degree is preferred.
At least 1 year of experience working in clinical research, preferably with experience in the regulatory space, is required.
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.