Senior Unblinded Clinical Research Associate
Posted Aug 6
Posted Aug 6
This is a fully remote position, open to applicants in Taiwan.
• Carry out unblinded site qualification, initiation, routine monitoring, and close-out visits at both local and international locations, particularly in Singapore.
• Supervise pharmacy processes and the management of Investigational Products.
• Ensure adherence to protocols, accountability for Investigational Products, verification of temperature logs, and patient safety while maintaining the integrity of trial blinding.
• Collaborate with site pharmacists and pharmacy personnel on study execution, unblinded dispensing, and the disposal or return of Investigational Products.
• Conduct unblinded data assessments, check pharmacy documentation, and address pharmacy inquiries in restricted-access areas.
• Prepare and evaluate unblinded study documents, which include pharmacy manuals, unblinded monitoring strategies, and logs for the destruction of Investigational Products.
• A Bachelor's degree in Pharmacy, Life Sciences, or a related healthcare field.
• At least 2 years of experience as a Clinical Research Associate, encompassing independent site monitoring visits.
• Comprehensive understanding of clinical trial processes and unblinded monitoring methodologies.
• Familiarity with local regulations, including HSA Singapore guidelines and ICH-GCP standards.
• Exceptional organizational skills, integrity, and strong communication abilities.
• Attentive to detail in relation to Investigational Product management.
• Capability to work autonomously and uphold stringent blinding protocols in a dynamic environment.
• Eagerness and flexibility to travel as needed, including regular regional trips to Singapore.
• A Registered Pharmacist license is preferred.
• Competitive base salary along with performance-related incentives.
• Health and wellness programs, including medical, dental, and vision coverage where applicable.
• Retirement and pension options.
• Life insurance and disability coverage.
• Employee assistance programs and wellness resources.
• Opportunities for learning and development through structured training and career pathways.
TFS HealthScience - Contract Research Organization
AstraZeneca
BeOne Medicines
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