Clinical Research Coordinator- QA- NCI Network Clinical Research Administration

Clinical Research Coordinator- NCI Network, Clinical Research Administration

As an integral member of the team responsible for overseeing conduct on our NCI-sponsored, NCTN and NCI consortium clinical trials and in compliance with all regulatory, institutional, and departmental requirements, the Clinical Research Coordinator provides regulatory support across the portfolio (~200 trials). Responsible for regulatory, and integrity checks at the service specific level. Participates in special projects and partners closely with IRB, SAE, FDA and QA teams as determined by management.

You will:

• Assists with regulatory processes across the portfolio
• Conducts Informed Consent and Eligibility verification for patients enrolled to NCI trials
• Prepares for cooperative group and NCI audits
• Participates in special projects and regularly interfaces with MSK regulatory teams (IRB, IND, SAE, etc) as determined by management.
• Utilizes appropriate methodologies to collect patient/human subject information for a research project, database, and/or protocol
• Assists with generation of reports on the progress of the research project, database, or protocol, as needed
• Assists in managing departmental data and portfolio metrics. Communicates with staff at all levels (principal investigators, clinical and research support staff).
• Assists in the review and maintenance of regulatory binders/documents
• Ensures 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
• Participates in study transitions to long term follow up team
• Ensures that workflows across the CRA are controlled and meet departmental needs
• Participates or coordinates on both interdepartmental and intradepartmental organization-wide research projects as requested
• Provides organizational, creative, or clerical support to established and new research initiatives

You need:

• A minimum of a High School Diploma and 2 years of relevant experience
• Must be able to work independently, be flexible, and meet tight deadlines
• Experience in research and/or other applicable research investigation
• Microsoft applications, database knowledge a plus
• The ability to be flexible to the possibility of working either on the MSKCC main campus or Bergen, NJ site.