Clinical Data Coordination and QA Auditing

The Clinical Data Coordination and QA Auditing subcontract supports the National Institutes of Health NICHD within the Department of Health and Human Services. The primary objective is to ensure data accuracy and quality for prime contractors managing high-risk randomized clinical trials. Key responsibilities include performing quality assurance auditing for approximately 50 clinical sites, monitoring the reporting of adverse events, and providing essential training for site data coordinators. To maintain regulatory compliance, all work must adhere to GCP, GLP, and OHRP Federal Wide Assurance standards. The successful contractor is expected to deliver validated clinical datasets, certified data coordinators, and detailed data audit reports. This opportunity is categorized under NAICS code 541611, with a response deadline set for December 18, 2026.