🚀 Drive Clinical Trial Integrity: CRA (Home-Based, Taiwan - FSP Model)
Join ICON plc, a world-leading healthcare intelligence and clinical research organization, as a Clinical Research Associate (CRA). This is a home-based role in Taiwan where you will be embedded within a dedicated sponsor partnership (FSP model), acting as the primary field expert to ensure the ethical, compliant, and efficient execution of clinical trials. You will be the vital link between our partner and investigative sites, safeguarding data quality and patient safety.
We are seeking an independent, proactive CRA to manage all aspects of site monitoring and study coordination. If you are a science-driven professional with strong site management skills and a commitment to excellence, this is your opportunity to advance your career within a focused, sponsor-dedicated model supported by a global CRO leader.
🎯 Your Site Management & Monitoring Mission: Key Responsibilities
End-to-End Site Oversight & Coordination
- Work independently to coordinate all site activities, including study set-up, initiation, routine monitoring, and close-out visits, ensuring strict adherence to protocols and regulations.
- Develop and maintain strong, collaborative relationships with clinical investigators and site staff to facilitate smooth trial operations and timely issue resolution.
- Complete accurate study status reports and maintain comprehensive study documentation, including the Trial Master File (TMF).
Data Integrity & Patient Safety Vigilance
- Perform rigorous source data verification (SDV) and data review to ensure the accuracy, completeness, and consistency of all clinical data.
- Run and resolve sponsor-generated queries efficiently, taking ownership of data clarification and correction processes.
- Ensure patient safety and rights by guaranteeing site compliance with the approved protocol, ICH-GCP, local TFDA regulations, and ICON/sponsor SOPs.
Operational Excellence & Cost Efficiency
- Take responsibility for study cost efficiency at the site level, managing monitoring timelines and resources effectively.
- Participate in the preparation and review of study documentation and contribute to feasibility assessments for new proposals as required.
- Proactively identify site-level risks and implement corrective actions to ensure study milestones are met.
⭐ Your Profile: CRA Qualifications & Expertise
Essential Requirements
- University degree in Medicine, Life Sciences, Pharmacy, Nursing, or an equivalent scientific field.
- Proven experience as a Clinical Research Associate (CRA), with hands-on site monitoring and management skills.
- In-depth knowledge of ICH-GCP guidelines and the ability to review and evaluate complex medical and clinical data.
- Excellent written and verbal communication skills in English and Mandarin.
- Ability to travel approximately 60% of the time (domestic and potentially regional), possessing a valid driver’s license.
Core Competencies
- Independent & Proactive: Ability to work autonomously, manage your sites effectively, and drive activities to completion.
- Exceptional Communicator: Strong interpersonal and relationship-building skills to manage stakeholders and resolve queries professionally and timely.
- Analytical & Detail-Oriented: Keen eye for detail with strong analytical skills to ensure data integrity and protocol compliance.
- Organized & Efficient: Strong project coordination skills to manage multiple tasks, maintain documentation, and ensure cost-effective monitoring.
💫 Why Build Your CRA Career in the FSP Model at ICON?
Deepen Expertise within a Focused Partnership
- Gain valuable, in-depth experience working closely with a dedicated sponsor, building strong therapeutic and procedural expertise.
- Enjoy the stability and focus of the FSP model while being fully supported by ICON’s global resources, training, and career development framework.
Home-Based Flexibility with Professional Growth
- 100% Home-Based in Taiwan: Maximize your work-life balance and productivity while conducting meaningful field-based work.
- Clear career progression pathways to Senior CRA, Clinical Team Lead, and other leadership roles within the global ICON and FSP structure.
- Receive comprehensive training and continuous support from an experienced line manager.
Competitive ICON Benefits in Taiwan
- Attractive salary package with performance-based incentives.
- Comprehensive health insurance offerings for you and your family.
- Generous annual leave entitlements.
- Competitive retirement planning offerings.
- Global Employee Assistance Programme (EAP) providing 24/7 confidential support.
- Car allowance and home-office setup support.
- Ongoing investment in your professional development.
✨ Ready to Be the Trusted Field Expert for Clinical Trials in Taiwan?
If you are an independent, travel-ready CRA looking to take ownership of your sites and contribute to pivotal clinical research within a dedicated partnership, we encourage you to apply. This CRA role within our FSP model offers a unique opportunity to ensure the highest standards of quality and compliance at the site level.
Apply Now and become the key field professional driving clinical trial success in Taiwan.