Advance your monitoring career in China. ICON seeks a CRA II to conduct site management & ensure GCP compliance for clinical trials. 2+ yrs monitoring exp & Chinese/English fluency required.
Be the Frontline Leader of Clinical Research Quality in China
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 a skilled and independent Clinical Research Associate II (CRA II) to join our field-based team across China. In this critical role, you will be the primary guardian of data quality and patient safety at our investigative sites. Building on your foundational monitoring experience, you will take on increased responsibility, managing more complex sites and studies to ensure trials are conducted with integrity, precision, and full compliance with local and global regulations.
Your Mission: Independent Site Management & Quality Assurance
As a CRA II at ICON, you will independently manage a portfolio of clinical trial sites. You will be trusted to conduct all monitoring visit types, solve complex site-level issues, and serve as the key liaison between the study protocol and its flawless execution in the field.
Key Responsibilities
1. End-to-End Site Management & Monitoring
- Independently conduct and manage all types of monitoring visits (Site Qualification, Initiation, Monitoring, and Close-Out) to ensure strict adherence to protocol, ICH-GCP, and Chinese regulatory (NMPA) requirements.
- Perform comprehensive source data verification (SDV) and review of essential documents to ensure data integrity and audit readiness.
- Proactively identify, manage, and resolve site-level issues related to patient recruitment, data discrepancies, protocol deviations, and drug accountability.
2. Investigator Partnership & Collaboration
- Build and maintain strong, collaborative, and professional relationships with Principal Investigators and site staff to drive performance and ensure patient safety.
- Provide protocol and GCP training to site personnel, ensuring a clear understanding of study requirements.
- Act as the main point of contact for assigned sites, facilitating clear communication between the site and the study team.
3. Data Integrity & Regulatory Stewardship
- Review data in EDC systems, resolve queries efficiently, and ensure timely data entry.
- Ensure the Trial Master File (TMF) is maintained in a complete 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 confident, detail-oriented professional with solid monitoring experience, ready to take the next step in your career. You are a self-starter who excels in a field-based setting, possesses strong diplomatic skills, and is driven by a passion for quality and compliance.
Your Required Foundation:
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Medicine, or a related field.
- Minimum of 2 years of independent, on-site monitoring experience as a Clinical Research Associate (CRA) within a pharmaceutical company, biotech, or global CRO.
- In-depth knowledge of ICH-GCP guidelines and China-specific clinical trial regulations (NMPA).
- Proven experience conducting all types of monitoring visits independently.
- Strong organizational skills with exceptional attention to detail.
- Excellent communication, interpersonal, and problem-solving skills.
- Professional fluency in both Mandarin and English (written and spoken) is mandatory.
- Willingness and ability to travel approximately 50-60%, as required.
What Sets You Apart (Preferred):
- Experience in multiple therapeutic areas.
- Experience with Risk-Based Monitoring (RBM) methodologies.
- Monitoring experience in complex trials (e.g., Oncology, Rare Diseases).
- Strong technical proficiency with EDC systems and clinical trial applications.
Why Grow Your Career as a CRA II at ICON in China?
1. Accelerated Professional Growth
- Manage a more complex and strategic portfolio of sites, building your expertise.
- Clear and defined career progression pathway to Senior CRA, Lead CRA, and Clinical Trial Manager (CTM) roles.
- Receive ongoing advanced training in therapeutic areas, monitoring techniques, and leadership skills.
2. Impact & Autonomy
- Enjoy a high level of autonomy and trust in managing your sites and regional territory.
- See the direct impact of your work on data quality and study success in a critical market.
3. Comprehensive Field-Based Package & Support
- Competitive salary and performance-based bonus.
- Comprehensive travel package, car allowance, and expenses coverage.
- Generous annual leave entitlements.
- Premium health, life, and disability insurance for you and your family.
- Global Employee Assistance Programme for 24/7 support.
- Technology package (laptop, mobile phone) and dedicated field-based management support.
Join Our Inclusive Mission Across China
At ICON, diversity and inclusion are fundamental to our success. We are committed to creating an accessible environment and encourage all qualified candidates across China to apply.
Ready to advance your monitoring career and ensure excellence in China’s clinical research landscape?
Apply now with your updated CV. Let’s shape the future of clinical development, together.
