Clinical Trial Management and Coordination

This subcontract for Clinical Trial Management and Coordination supports prime contractors on National Institutes of Health cancer research projects. The scope of work involves the recruitment, enrollment, and monitoring of human subjects between the ages of 18 and 49. Key responsibilities include processing informed consent, coordinating trial sites through patient registries and Clinical Trial Management Systems, and ensuring all activities maintain IRB or IEC approval and proper registration with ClinicalTrials.gov. The contractor is responsible for delivering fully enrolled patient cohorts and detailed compliance reports to the Department of Health and Human Services. This engagement falls under NAICS code 541714 and is structured to ensure rigorous adherence to clinical research standards and regulatory requirements throughout the duration of the study.