Clinical Trial Assistant I – Taipei

About the role

Everest Clinical Research is seeking a motivated Clinical Trial Assistant I to join its Taipei office. The role supports Clinical Operations throughout the lifecycle of clinical trials, ensuring smooth start‑up, execution, and close‑out in compliance with ICH‑GCP and local regulations.

Key responsibilities

• Interact with sponsors, investigational sites, vendors, and internal functional groups to facilitate timely trial operations.
• Compile and review site qualification documentation to verify compliance with ICH‑GCP and local rules.
• 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 inspection readiness and eventual archiving.
• Support site identification, feasibility questionnaire distribution, and site selection processes.
• Contribute to the creation of Clinical Operations documents such as Investigator Site File logs and newsletters.

Required profile

• Committed, skilled, and customer‑focused individual.
• Understanding of ICH‑GCP principles and local regulatory requirements.
• Ability to manage documentation accurately and meet tight timelines.
• Strong communication skills for interaction with sponsors, sites, and internal teams.

Required skills

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

What we offer

• Opportunity to work with leading pharmaceutical, biotechnology, and medical device companies.
• Dynamic, growth‑focused environment with entrepreneurial spirit.
• Exposure to a wide range of therapeutic areas and advanced clinical projects.