Document Reviewer

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We are looking for a skilled Clinical Research Document Reviewer with 2-6 years of experience to ensure the quality, accuracy, and compliance of clinical research documentation. The ideal candidate will work closely with clinical research teams to review, verify, and manage essential documents related to clinical trials, while adhering to regulatory standards.

Key Responsibilities:

• Review clinical trial documents (protocols, CRFs, ICFs, CSRs) for accuracy, consistency, and compliance with regulatory requirements.
• Ensure that all documents meet industry standards (ICH-GCP, FDA, EMA) and internal quality guidelines.
• Identify and resolve discrepancies in documentation in collaboration with relevant stakeholders (CRAs, investigators, project managers).
• Manage document control processes, including version control, document storage, and retrieval.
• Support audits and inspections by maintaining an audit-ready document repository and providing requested documentation.
• Conduct quality checks (QC) on documentation before submission to regulatory authorities.
• Stay updated on clinical research regulations and contribute to the development of SOPs related to document management.
• Provide training to team members on document review processes, as needed.