Senior Clinical Research Associate (Oncology)

About the role

The Senior Clinical Research Associate (CRA) will lead complex oncology and rare disease clinical trials in Taiwan, overseeing site start‑up, monitoring, and close‑out activities. The role requires independent management of study sites, ensuring patient safety, data quality, and regulatory compliance while mentoring junior staff.

Key responsibilities

• Oversee all aspects of site management to ensure low query rates, audit readiness, and high data quality.
• Manage start‑up activities including feasibility assessments, IRB/EC submissions, regulatory document collection, and investigator contract negotiations.
• Conduct pre‑study, initiation, routine monitoring, and close‑out visits in accordance with ICH‑GCP and company SOPs.
• Prepare accurate monitoring reports, maintain trial management tools, and reconcile Investigator Site Files with Trial Master Files.
• Support patient recruitment, retention, and informed‑consent processes.
• Perform investigational product inventory, reconciliation, and ensure proper handling and dispensing.
• Identify and escalate site risks, manage SAE reporting, and coordinate corrective actions with project teams.
• Mentor and train junior CRAs, contribute to protocol development and study documentation.

Required profile

• Bachelor’s degree or equivalent in a scientific, business, or healthcare discipline.
• Minimum 3.5 years of on‑site monitoring experience, preferably in oncology and global trials.
• Willingness to travel 60‑70% of the time.
• Strong attention to detail and high accuracy.
• Excellent organizational and communication skills in English.

Required skills

• Proficiency with Microsoft Office suite (Outlook, Word, Excel, PowerPoint).
• Knowledge of ICH‑GCP guidelines and drug development processes.
• Ability to work independently and manage multiple sites simultaneously.