Seeking an experienced Senior CRA in China. Lead site management, ensure GCP compliance & data integrity for top-tier clinical trials. Field-based role with 60% travel. Apply your expertise at a global CRO leader.
Be the Frontline Leader of Clinical Research Excellence
ICON plc is a world-leading healthcare intelligence and clinical research organization. Our mission is to accelerate the development of drugs and devices that save lives and improve quality of life.
We are seeking an accomplished Senior Clinical Research Associate (Senior CRA) to be a key leader in our monitoring team. In this critical field-based role, you will be the primary guardian of data quality and patient safety at our investigative sites. Your expertise will ensure trials are conducted with unwavering integrity, compliance, and efficiency, directly contributing to the reliable outcomes that shape medical futures.
Your Mission: Ensure Integrity from the Site Up
As a Senior CRA at ICON, you will take ownership of a portfolio of clinical trial sites. You will be trusted to independently manage, mentor, and problem-solve, serving as the vital link between the study protocol and its flawless execution in the field.
Key Responsibilities
1. Expert Site Management & Monitoring
- Conduct all types of site visits (selection, initiation, monitoring, close-out) to ensure strict adherence to the study protocol, ICH-GCP guidelines, and local regulatory requirements.
- Proactively identify, manage, and resolve site-level issues related to patient recruitment, data discrepancies, non-compliance, and drug accountability.
- Perform comprehensive source data verification (SDV) and review essential documents to ensure data integrity and audit-readiness.
2. Leadership & Collaboration
- Serve as a subject matter expert and point of escalation for assigned sites and junior team members.
- Provide training, guidance, and support to site staff and other CRAs to elevate the standard of clinical trial conduct.
- Collaborate effectively with cross-functional internal teams (Clinical Trial Management, Data Management, Safety) to ensure timely deliverables and clear communication.
3. Relationship & Compliance Stewardship
- Build and maintain strong, collaborative, and professional relationships with Principal Investigators and site coordinators to drive performance and partnership.
- Ensure the Trial Master File (TMF) is maintained in a timely and inspection-ready state for all assigned sites.
- Contribute to site and study-level risk management plans and quality improvement initiatives.
Who You Are: The Ideal Candidate
You are a seasoned, independent, and diplomatic professional who thrives in a field-based setting. You are driven by a passion for quality, possess exceptional attention to detail, and excel at building relationships that foster compliance and excellence.
Your Required Foundation:
- Bachelor’s or advanced degree in Life Sciences, Nursing, Medicine, or a related field.
- Substantial experience as a Clinical Research Associate (CRA), with a proven track record of independent site management.
- In-depth knowledge of ICH-GCP, local Chinese clinical trial regulations (NMPA), and standard clinical trial procedures.
- Proven ability to manage multiple sites and studies simultaneously with superior organizational skills.
- Expertise in monitoring practices, data integrity assurance, and using clinical trial software (EDC, CTMS, TMF).
- Exceptional communication, interpersonal, and problem-solving skills.
- Ability to travel approximately 60% (domestic/international). A valid driver’s license is required.
- Professional fluency in English and Mandarin.
What Sets You Apart (Preferred):
- Experience in multiple therapeutic areas.
- Previous experience in a global CRO or sponsor environment.
- Experience mentoring or training junior CRAs or site staff.
- Strong skills in root cause analysis and corrective/preventive action planning.
Why Advance Your Monitoring Career at ICON?
1. Autonomy & Impact
- Take ownership of complex sites and studies, with the trust and autonomy to manage them strategically.
- See the direct impact of your work on data quality and study success.
- Play a key role in mentoring the next generation of CRAs.
2. Career Growth Pathways
- Clear progression routes into Lead CRA, Clinical Trial Manager (CTM), or Site Management leadership roles.
- Access to continuous professional development in advanced monitoring techniques, therapeutic areas, and leadership skills.
3. Comprehensive Field-Based Support & Benefits
- Competitive salary and performance-based bonus.
- Comprehensive travel package and expenses coverage.
- Generous annual leave entitlements.
- Premium health, life, and disability insurance for you and your family.
- Competitive retirement planning offerings.
- Global Employee Assistance Programme for 24/7 support.
- Car allowance or company car (country-specific).
- Technology package (laptop, mobile phone).
Join Our Inclusive Mission
At ICON, diversity and inclusion are more than words; they are integral to our success. We are committed to creating an accessible environment and encourage all qualified candidates to apply.
Ready to elevate clinical research standards across China?
Apply now with your updated CV and cover letter. Lead with integrity from the field.
