Clinical Trial Assistant I

About the role

Everest Clinical Research is seeking a motivated Clinical Trial Assistant I to support the operational execution of clinical studies. The role can be based onsite in Markham, ON, or performed remotely from any location in Canada.

Key responsibilities

• Interact with study sponsors, investigational sites, vendors and internal functional groups to ensure timely, high‑quality trial execution in compliance with ICH‑GCP and local regulations.
• Compile and review site qualification documentation to verify regulatory compliance.
• Assist in preparing and submitting regulatory documents to authorities and ethics committees.
• Set up, maintain and archive study records in the Trial Master File (TMF) and Clinical Trial Management System (CTMS).
• Maintain essential site files for continuous availability and future archiving.
• Support site identification, feasibility questionnaire development, distribution and site selection processes.
• Contribute to the creation of clinical operations documents such as Investigator Site File logs and newsletters.

Required profile

• Committed, customer‑focused individual with strong attention to detail.
• Understanding of ICH‑GCP guidelines and relevant local regulatory requirements.
• Ability to communicate effectively with sponsors, sites and internal teams.
• Organised and capable of handling multiple tasks in a fast‑paced environment.

Required skills

• Trial Master File (TMF) management
• Clinical Trial Management System (CTMS) usage