🚀 Lead Clinical Trial Excellence: Senior CRA (Home-Based, Taiwan - FSP Model)
Join ICON plc, a world-leading healthcare intelligence and clinical research organization, as a Senior Clinical Research Associate (Senior CRA). This is a prestigious home-based role in Taiwan where you will be embedded within a dedicated sponsor partnership (FSP model). You will serve as the primary expert overseeing site quality, data integrity, and patient safety, ensuring our partner’s clinical trials are executed to the highest scientific and ethical standards.
We are seeking an experienced, autonomous, and influential monitoring professional to lead site management for critical clinical studies. If you are a strategic thinker with deep regulatory expertise, a passion for mentoring, and a drive to ensure operational excellence, this is your opportunity to take your career to the next level with a global leader.
🎯 Your Senior-Level Monitoring Mission: Key Responsibilities
Strategic Site Leadership & Oversight
- Serve as the primary site relationship and quality lead for assigned clinical trial sites, conducting complex site selection, initiation, monitoring, and close-out visits with a focus on strategic risk management.
- Proactively identify, escalate, and resolve critical site issues, implementing robust corrective and preventive action plans to ensure protocol compliance and data integrity.
- Train, mentor, and guide site staff and junior CRAs, elevating the standard of clinical trial conduct and fostering a culture of quality and compliance.
Data Integrity & Patient Safety Stewardship
- Conduct sophisticated source data verification (SDV) and in-depth data review to guarantee the accuracy, consistency, and completeness of all clinical data.
- Ensure the highest standards of patient safety and rights protection, verifying that all site activities strictly adhere to the approved protocol, ICH-GCP, and local TFDA regulations.
- Lead investigations into complex protocol deviations, adverse events, and data anomalies, driving to root cause and sustainable resolution.
Cross-Functional Collaboration & Influence
- Act as the key operational interface between the sponsor, investigative sites, and internal ICON teams (Clinical Operations, Data Management, Safety, Regulatory).
- Influence and drive compliance within a complex environment, providing expert counsel to both site and sponsor stakeholders on monitoring practices and regulatory expectations.
- Contribute to trial-level strategy, including risk planning, patient recruitment strategies, and process improvement initiatives.
Documentation Excellence & Regulatory Mastery
- Ensure the Trial Master File (TMF) is maintained in a state of constant inspection readiness for your sites.
- Prepare and review high-quality monitoring visit reports, follow-up letters, and essential study documentation.
- Maintain expert knowledge of ICH-GCP, local TFDA regulations, and sponsor-specific SOPs.
⭐ Your Profile: Senior CRA Expertise
Essential Qualifications
- Advanced degree in Life Sciences, Nursing, Medicine, or a related healthcare/scientific field.
- Extensive, proven experience as a Clinical Research Associate, with a track record of successfully managing multiple complex sites and studies independently.
- Deep understanding of clinical trial processes, ICH-GCP, and Taiwan (TFDA) regulatory requirements.
- Fluency in Mandarin and professional proficiency in English (written and verbal) is mandatory.
- Ability to travel approximately 60% of the time (domestic and potentially regional), possessing a valid driver’s license.
Core Competencies & Leadership Attributes
- Expert Monitoring & Site Management: Mastery of all aspects of the monitoring visit cycle and remote monitoring techniques.
- Strategic Problem-Solving: Advanced ability to anticipate risks, diagnose complex issues, and implement strategic solutions.
- Influential Communication: Exceptional interpersonal and stakeholder management skills, with the ability to mentor, negotiate, and drive alignment at all levels.
- Operational Excellence: Superior organizational skills to manage multiple priorities and projects simultaneously while maintaining impeccable attention to detail.
- Technical Proficiency: High competency with clinical trial software (CTMS, EDC, eTMF) and data review tools.
💫 Why Build Your Senior Career in the FSP Model at ICON?
Deepen Your Expertise with a Dedicated Sponsor
- Gain immersive experience within a focused sponsor partnership, allowing for deeper therapeutic and procedural expertise.
- Enjoy the stability and long-term relationship of the FSP model while being supported by ICON’s global infrastructure and resources.
Career Growth & Leadership Development
- Clear pathway to Clinical Team Lead, Clinical Project Manager, or Functional Leadership roles.
- Opportunities to mentor junior staff, lead therapeutic area initiatives, and contribute to strategic process improvements.
Home-Based Flexibility with Global Impact
- 100% Home-Based in Taiwan: Maximize your productivity and work-life balance while being a key player in global clinical development.
- Receive dedicated support from an experienced line manager and access to ICON’s world-class training and development programs.
Competitive ICON Benefits in Taiwan
- Attractive salary package with senior-level performance incentives.
- Comprehensive health insurance plans for you and your family.
- Generous annual leave entitlements.
- Competitive retirement planning offerings.
- Global Employee Assistance Programme (EAP) providing 24/7 support.
- Car allowance and home-office setup support.
- Continuous investment in your professional growth and development.
✨ Ready to Lead as the Trusted Expert for Clinical Sites in Taiwan?
If you are a senior monitoring professional seeking a role with greater autonomy, strategic impact, and a dedicated partnership, we encourage you to apply. This Senior CRA position within our FSP model offers a unique opportunity to be the leading authority on site quality and compliance for groundbreaking clinical trials.
Apply Now and become the senior expert who ensures excellence and integrity at every stage of the clinical trial lifecycle in Taiwan.
