Regulatory Research Associate- Department of Radiology
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 accurate conduct of clinical research by developing, revising and maintaining accurate protocol tools.
Perform regular audits to ensure that the data and regulatory items collected is complete and accurate and to ensure that the research project is completed as outlined.
Work closely with management to assist with all of the regulatory oversight for clinical trials in the services, from start-up through study closeout, and protocols in development.
Will assist with protocol submission, drafting of consents, reviewing protocol logistics.
Assist in protocol audits- reviewing and collecting regulatory documents, provide data entry assistance if needed.
House all CVs, medical licenses, certifications and ensure they are current.
Participate in special projects and task forces as determined by management.
Utilize appropriate methodologies to collect patient/human subject information for a research project, database, and/or protocol.
Generate reports to all vital parties on the progress of the research project, database, or protocol, as needed.
Assist in handling departmental data. Connect with staff at all levels (principal investigators, clinical and research support staff). Have worked with principal investigators.
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 (IRB) and followed as written.
Work closely with research team to ensure regulatory requirements are met for Investigational New Drug (IND) studies; report applicable information to regulatory bodies for IND studies
Liaise with external entities on protocol requirements and help navigate regulatory submissions
Ensure that workflow is controlled and meets departmental needs. Leads ongoing departmental projects and crafts processes to ensure that goals are met.
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 experience at least 1 year of clinical research or applicable experience.
A Bachelors degree is preferred.
An ability to work independently, be flexible, and meet tight deadlines.
Microsoft applications, database knowledge a plus.
Must have an extensive 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).
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.