Clinical Research Associate

About the role

The Clinical Research Associate will be accountable for performance and compliance of assigned protocols and sites in Taiwan. Reporting to the CRA‑Manager, the role ensures study conduct follows ICH/GCP, local regulations, and company policies.

Key responsibilities

• Develop and maintain strong site relationships throughout all trial phases.
• Perform site monitoring activities (remote and on‑site) to ensure data quality, subject safety, and regulatory compliance.
• Coordinate site start‑up tasks, manage regulatory documentation, and support site readiness.
• Conduct validation, initiation, monitoring, and close‑out visits and produce comprehensive visit reports.
• Identify and resolve site performance issues, escalating when necessary.
• Maintain study information in CTMS, eTMF and other systems.
• Contribute to CRA team knowledge as a subject‑matter expert and mentor.

Required profile

• Fluent in English and local language with excellent communication skills.
• Minimum 5 years of healthcare experience, including at least 2 years of direct site monitoring in pharma/CRO.
• Strong understanding of clinical research phases, GCP/ICH guidelines, and local regulations.
• Proven ability to manage complex issues, perform root‑cause analysis and implement corrective actions.
• Effective time‑management, independent work style and ability to operate in a multicultural matrix environment.

Required skills

• Adverse Event Reporting System
• Clinical Research Methods
• Clinical Site Management
• Clinical Study Management
• Clinical Trials Monitoring
• Good Clinical Practice (GCP) and Good Clinical Data Management Practice (GCDMP)
• Regulatory Inspections and Remote Monitoring
• Data Analysis and Decision Making
• MS Office and various clinical IT applications