Source Document Specialist

Job Summary

A company is looking for a Source Document Specialist who is responsible for ensuring accurate, compliant, and efficient clinical trial documentation.

Key Responsibilities

• Prepare and develop accurate source documents based on clinical trial protocols, ensuring compliance with relevant regulations
• Review and validate source documents for completeness and accuracy, coordinating with site staff and internal teams
• Maintain version control and implement protocol amendments efficiently while ensuring compliance with regulatory requirements

Required Qualifications, Training, and Education

• Bachelor's degree in a health-related field preferred, or equivalent work experience in clinical research
• Minimum of 2 years of experience in clinical research, preferably as a Clinical Research Coordinator or in a similar role
• Strong knowledge of clinical trial operations, GCP guidelines, and regulatory compliance
• Proficiency in Microsoft Excel, Word, SharePoint, and other digital documentation tools
• Fluency in Portuguese and English for effective communication and documentation