Research Regulatory Associate, NCI Network Remote/Hybrid
Memorial Sloan Kettering Cancer Center
Location: Montvale, New Jersey
Academic / Research
Internal Number: 2021-52387
Regulatory Research Associate - Multi-site Compliance
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 the NCI Network Portfolio of studies. 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.
Ensure that all appropriate Institutional, State, and Federal regulations are followed throughout the course of a research project, database, or protocol. Ensures that research protocols are approved by the Institutional Review Board and followed as written.
Work closely with management to assist in all aspects of regulatory oversight for trials from start-up through study closeout, and protocols in development.
Will assist in protocol submission, drafting of consents.
Assist in protocol audits- reviewing and collecting regulatory documents, provide data entry assistance if needed.
Maintain required documents as applicable, including but not limited to Financial Disclosures, FDA 1572, training documentation and delegation of authority logs.
Provide required documents to Sponsors as requested.
Generate reports to all necessary parties on the progress of the research project, database, or protocol, as needed.
Field questions from MSK study teams and escalate questions to PIs/Sponsors.
Participate or coordinate on both interdepartmental and intra-departmental organization-wide research projects as requested.
Provide leadership, organizational, creative, or clerical support to established and new research initiatives.
A minimum of a High School Diploma with 2 years experience in clinical research or applicable experience.
A Bachelors degree is preferred.
Must have a comprehensive knowledge and understanding 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).
Impeccable attention to detail
Must be able to work independently, be flexible, and meet tight deadlines.
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.