Clinical Operations Assistant (CTA)

About the role

The Clinical Operations Assistant (CTA) supports the clinical project team throughout the study lifecycle, from site activation to close‑out. The role ensures that sites have the necessary access, documentation, and training to meet study timelines and quality standards.

Key responsibilities

• Assist site staff with vendor system access and quarterly access reconciliation.
• Coordinate investigator site file printing, shipment, and equipment/material logistics.
• Provide project data (e.g., investigator availability) to the clinical leadership team.
• Manage the Trial Master File (TMF), upload documents, update the Expected Document List, and resolve quality issues.
• Follow up on pending documents, trainings, data entry, and safety information with site and internal teams.
• Support investigator payment management and assist CRAs with site issue resolution.
• Update CTMS and other study trackers with site information and monitor trial progress.
• Assist with equipment return, database lock activities, and administrative close‑out procedures.
• Ensure compliance with ICH‑GCP, local regulations, and internal SOPs.

Required profile

• Strong attention to detail and ability to work independently while escalating issues when needed.
• Good understanding of clinical trial documentation and regulatory requirements.
• Effective communication with site staff, vendors, and internal teams.

Required skills

• Proficiency with Clinical Trial Management Systems (CTMS).
• Experience using Electronic Document Management Systems (EDMS).
• Advanced Microsoft Office skills.