Research Regulatory Associate - Protocol Activation

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.

You will:

• Perform regular audits to ensure that the data collected is complete and accurate and to ensure that the research project is completed as outlined.
• Work closely with management to assist in all aspects of regulatory oversight for trials in the service, from start-up through study closeout, and protocols in development.
• Will assist in 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 necessary parties on the progress of the research project, database, or protocol, as needed.
• Assist in handling departmental data. Communicate with staff at all levels (principal investigators, clinical and research support staff).
• 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.
• Ensure that workflow is controlled and meets departmental needs. Manages 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.

You need:

• A minimum of a High School Diploma with experience in clinical research or applicable experience.
• A Bachelors degree is preferred.
• Must be able to work independently, be flexible, and meet tight deadlines.
• Microsoft applications, database knowledge a plus.
• 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).

Hours:

• Monday - Friday, 9 am - 5 pm