Clinical QC Consultant Job Description

Position Overview

The Clinical QC Consultant is responsible for ensuring the quality, accuracy, and compliance of clinical trial documentation and data. This role supports clinical operations by performing quality control reviews and ensuring adherence to regulatory requirements and internal standards.



Key Responsibilities

• Perform QC review of clinical documents, including:
  
  
  
  • Clinical study reports (CSRs)
  
  
  • Protocols and protocol amendments
  
  
  • Informed consent forms (ICFs)
  
  
  • Monitoring visit reports
  
  
  • Trial master file (TMF) documents
  
  
  
  


• Ensure compliance with:
  
  
  
  • Food and Drug Administration (FDA) regulations
  
  
  • Internationa...