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Senior Unblinded Clinical Research Associate
ICON plcUnblinded Clinical Research Associate overseeing pharmacy processes and investigational products for ICON, a global clinical research organisation, in Taiwan. Conducting independent monitoring visits while protecting trial blinding and patient safety.
Core Competencies
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Demonstrates expertise in clinical trial processes, unblinded monitoring procedures, and Investigational Product management, ensuring compliance with local regulations and ICH-GCP guidelines. Strong organizational and communication skills are essential for effective collaboration with site pharmacists and maintaining trial integrity.
ATS Keywords
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Tech Stack
Tools & technologiesAbout the role
Key responsibilities & impact- Conduct unblinded site qualification, initiation, routine monitoring, and close-out visits at local and international sites, specifically Singapore
- Oversee pharmacy processes and Investigational Product management
- Ensure protocol compliance, IP accountability, temperature log verification, and patient safety while maintaining trial blinding
- Collaborate with site pharmacists and pharmacy staff on study conduct, unblinded dispensing, and IP disposal or return
- Perform unblinded data reviews, pharmacy documentation checks, and resolve pharmacy queries in restricted-access spaces
- Prepare and review unblinded study documentation, including pharmacy manuals, unblinded monitoring plans, and IP destruction logs
Requirements
What you’ll need- Bachelor's degree in Pharmacy, Life Sciences, or a healthcare-related field
- Minimum of 2 years of experience as a Clinical Research Associate, including independent site monitoring visits
- In-depth knowledge of clinical trial processes and unblinded monitoring procedures
- Knowledge of local regulations, including HSA Singapore guidelines, and ICH-GCP guidelines
- Strong organizational, integrity-driven, and communication skills
- Meticulous attention to detail regarding Investigational Product management
- Ability to work independently and maintain strict blinding firewalls in a fast-paced environment
- Willingness and flexibility to travel as required, including regular regional travel to Singapore
- Registered Pharmacist license preferred
Benefits
Comp & perks- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways