CRA II role in Beijing! Office-based with travel. Conduct site monitoring, ensure GCP & NMPA compliance. 2+ yrs independent monitoring exp & Chinese/English fluency required.
Advance Clinical Research from Our Beijing Hub: Office-Based with Field Impact
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 Clinical Research Associate II (CRA II) to join our Beijing office in a unique hybrid role. This position offers the stability and collaboration of an office-based environment combined with the field-based impact of site monitoring. You will be the primary guardian of data quality and patient safety at investigative sites, managing all aspects of site performance while benefiting from the support and resources of our central Beijing team. This is an excellent opportunity to grow your monitoring career with a balanced, supportive structure.
Your Mission: Independent Site Management with a Team Anchor
As a CRA II in Beijing, you will independently manage a portfolio of clinical trial sites. Leveraging your experience, you will conduct critical monitoring visits, build strong site relationships, and ensure protocol adherence, all while having a dedicated office base for planning, reporting, and team collaboration.
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 the study protocol, ICH-GCP guidelines, and NMPA regulations.
- 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, and protocol compliance.
2. Investigator Partnership & Data Integrity
- Build and maintain strong, collaborative relationships with Principal Investigators and site staff to drive performance and ensure patient safety.
- Review data in EDC systems, resolve queries efficiently, and ensure the timely entry of high-quality clinical data.
- Ensure the Trial Master File (TMF) is maintained in a complete and inspection-ready state for all assigned sites.
3. Office-Based Collaboration & Reporting
- Utilize the office base for detailed visit report writing, trip planning, and preparation of site communication.
- Collaborate closely with office-based Clinical Trial Managers, Data Management, and Regulatory teams to ensure seamless study execution.
- Contribute to the preparation and review of key study documentation.
Who You Are: The Ideal Candidate
You are an independent and detail-oriented monitoring professional with solid experience, ready to take on greater responsibility. You value both the autonomy of field work and the support of a team environment, and you excel at managing your territory efficiently.
Your Required Profile:
- 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.
- Ability to travel approximately 60% (domestic/international). A valid driver’s license is required.
What Sets You Apart (Preferred):
- Experience in multiple therapeutic areas.
- Monitoring experience in complex trials (e.g., Oncology, Immunology).
- Strong technical proficiency with EDC systems and clinical trial applications.
Why Grow Your Career as a CRA II at ICON in Beijing?
1. Best of Both Worlds: Office & Field
- Enjoy the collaborative environment and resources of our Beijing office without being permanently remote.
- Maintain direct site impact and ownership through regular travel, balanced with dedicated administrative support time.
2. Accelerated Professional Growth
- Manage a strategic portfolio of sites with increased autonomy.
- Clear and defined career progression pathway to Senior CRA, Lead CRA, and Clinical Trial Manager (CTM) roles.
- Receive ongoing advanced training and mentorship.
3. Comprehensive Beijing-Based Package
- Competitive salary and performance-based bonus.
- Comprehensive travel package, including transportation 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.
- Modern office facilities in a central Beijing location.
Join Our Inclusive Mission in Beijing
At ICON, diversity and inclusion are fundamental to our success. We are committed to creating an accessible environment and encourage all qualified candidates to apply.
Ready to advance your monitoring career with the perfect balance of field impact and office support?
Apply now with your updated CV to join our Beijing team.
