đď¸Â Lead Clinical Research Excellence: Senior CRA - Shanghai (Office-Based)
Join ICON plc in Shanghai as a Senior Clinical Research Associate and become the cornerstone of clinical trial excellence in China's dynamic healthcare landscape. This office-based role positions you at the heart of Asia's clinical research hub, where your expertise will drive protocol adherence, data integrity, and patient safety across leading research institutions.
As a world-leading healthcare intelligence organization, we're seeking an experienced CRA to manage complex clinical trials from our Shanghai office. If you're passionate about advancing medical research and excel in China's regulatory environment, this is your opportunity to build a meaningful career while contributing to groundbreaking clinical development in one of the world's fastest-growing research markets.
đŻÂ Your Clinical Leadership Mission: Key Responsibilities
Site Monitoring Excellence
- Conduct comprehensive site monitoring visits across China to ensure strict adherence to study protocols and GCP standards
- Perform meticulous source data verification and case report form review with precision and attention to detail
- Assess site performance, resolve complex issues, and provide expert support to ensure successful trial execution
- Verify proper documentation practices and maintain inspection readiness at all assigned sites
Regulatory Compliance & Quality Assurance
- Ensure all clinical trial activities comply with China NMPA regulations, ICH-GCP guidelines, and local requirements
- Monitor regulatory document collection and maintenance throughout the trial lifecycle
- Implement quality control measures and identify process improvements for enhanced compliance
- Support sites in preparing for regulatory inspections and sponsor audits
Cross-Functional Collaboration
- Collaborate effectively with clinical operations, data management, and regulatory affairs teams
- Ensure timely and accurate data collection, query resolution, and study reporting
- Provide training and guidance to site staff and junior CRAs on protocol requirements and best practices
- Participate in investigator meetings and study team discussions as clinical operations expert
Stakeholder Relationship Management
- Build and maintain strong, productive relationships with investigators and site personnel across China
- Serve as primary point of contact for site queries and operational support needs
- Facilitate smooth trial operations through proactive communication and problem-solving
- Represent ICON with professionalism and expertise at clinical research sites
â Your Profile: Senior CRA Expertise
Essential Qualifications
- Advanced degree in Life Sciences, Nursing, Medicine, or related clinical field
- Extensive experience as Clinical Research Associate with comprehensive understanding of clinical trial processes
- Strong knowledge of China NMPA regulations and local clinical research requirements
- Business-level proficiency in both Chinese and English (written and spoken)
Technical Competencies
- Expertise in clinical monitoring practices, data integrity standards, and site management protocols
- Proficiency with clinical trial software, electronic data capture systems, and CTMS platforms
- Experience with regulatory document requirements and submission processes in China
- Understanding of clinical trial phases and therapeutic area-specific requirements
Professional Attributes
- Proven ability to manage multiple sites and projects simultaneously with exceptional organizational skills
- Strong problem-solving capabilities for addressing complex site challenges and compliance issues
- Excellent communication skills for effective collaboration across diverse stakeholder groups
- Leadership mindset with ability to mentor junior team members and guide site staff
Travel Requirements
- Ability to travel minimum 60% across China (domestic and potentially international)
- Valid driver's license for site visits requiring road travel
- Flexibility for extensive travel to research institutions throughout China
- Comfort with fly-and-drive assignments across multiple regions
đŤÂ Why Build Your CRA Career at ICON Shanghai?
Impact China's Clinical Research Landscape
- Contribute to advancing medical research in one of the world's most important healthcare markets
- Work with leading research institutions and key opinion leaders across China
- Play crucial role in bringing innovative treatments to Chinese patients
- Ensure highest standards of clinical research quality and patient safety
Office-Based Professional Community
- Work from ICON's modern Shanghai office with collaborative team environment
- Balance structured office collaboration with field-based site monitoring
- Access to comprehensive technology infrastructure and support resources
- Participate in local professional networks and clinical research community
Career Growth & Development
- Clear pathway to Lead CRA, Clinical Team Lead, and Project Management roles
- Exposure to diverse therapeutic areas and complex study designs
- Opportunities for specialization in high-demand therapeutic areas
- Professional development programs and certification support
Competitive ICON China Benefits
- Attractive salary package with performance incentives
- Comprehensive health insurance for you and your family
- Global Employee Assistance Programme with Chinese language support
- Generous annual leave with Chinese public holidays
- Retirement planning benefits and financial security
- Travel allowance and expense coverage for site monitoring
- Professional development allowance and training opportunities
â¨Â Ready to Advance Clinical Research in China?
If you're an experienced CRA with expertise in China's clinical research environment and passion for quality excellence, we encourage you to apply. This Senior CRA role offers the unique opportunity to advance your career while ensuring the highest standards of clinical trial execution across China's growing research ecosystem.
Apply Now and become ICON's next Clinical Research Leader in Shanghai!
