TheQuality Control (QC) Associateis responsible for reviewing, identifying and assists in addressing staff Good Documentation Practice issues, study information discrepancies, and SOP and Study Protocol deviations. The QC Associate reviews study source documents ensuring compliance with the protocol and ensures potential Quality Issues are identified and reported immediately to QA. This role also assists in preparing study related documents prior to study participant visits, internal, or third-party audits, and monitoring visits. The QC Associate provides feedback to the team as needed on QC findings and trends, recommends the need for clinical trial staff training/re‑training, and ensures that Corrective Action Preventive Action processes are observed and implemented.

Primary Responsibilities

• Reviews study files after completion and ensures that they are accurate and legible according to specific protocols, SOPs, and regulations
• Ensures all prep...