Clinical Research Associate II / Senior CRA – Taipei

About the role

Fortrea is preparing for future clinical trial opportunities in Taipei. The Clinical Research Associate II / Senior CRA will be responsible for on‑site monitoring and site management of global Phase 1‑3 studies, ensuring compliance with SOPs, regulatory guidelines and sponsor requirements.

Key responsibilities

• Perform routine site monitoring visits, initiation, and close‑out visits, maintaining accurate study files and trip reports.
• Verify informed consent, protocol adherence, and data integrity on case report forms and electronic data capture systems.
• Manage study supplies, liaise with vendors, and coordinate feasibility and regulatory submissions.
• Track and follow‑up serious adverse events, generate queries, and ensure audit readiness at the site level.
• Support senior CRA in budget management, investigator recruitment, and training of new monitors.

Required profile

• Bachelor’s degree with strong emphasis in science or biology.
• Minimum 2 years of direct on‑site monitoring experience in global Phase 1‑3 studies.
• Fluent in English and local language (written and verbal).
• Ability to work independently and within a matrix project team.

Required skills

• Proficiency with IVRS, electronic data capture (EDC) and trial master file (TMF) systems.
• Experience reviewing CRFs, generating and resolving data queries.
• Strong computer skills, including Microsoft Office suite.