Senior Clinical Research Associate

Pfizer · Taipei, Taiwan

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Clinical OperationsFull-timeCompany career page

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Role summary

Senior Clinical Research Associate position overseeing site management, monitoring, and close-out of clinical trial investigator sites. Responsible for ensuring patient safety, regulatory compliance, and quality study execution across assigned sites from initiation through database lock.

What they're looking for

Bachelor's degree in life sciences or professional degree (nursing, pharmacy, medicine) or equivalent
Minimum 5 years clinical research site monitoring experience
Extensive knowledge of clinical trial methodologies, ICH/GCP, and FDA regulations
Fluent in English and Mandarin Chinese
Global clinical trial experience
Preferred oncology, vaccines, internal medicine, or infectious disease background

What you'll be doing

Manage investigator site operations from initiation through database lock, ensuring compliance with protocols and applicable regulations
Conduct onsite and remote monitoring activities, addressing protocol deviations and emerging operational or clinical risks
Serve as primary contact for assigned investigator sites, coordinating information flow between study teams and site personnel
Monitor adverse events and serious adverse events, collaborating with Drug Safety Unit to resolve reporting requirements
Identify, resolve, and develop corrective actions for site-level issues within required timeframes

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