🚀 Advance Clinical Research: CRA II, Shanghai (Office with Flexibility)
Join ICON plc, a world-leading healthcare intelligence and clinical research organization, as a Clinical Research Associate II (CRA II) in Shanghai. This is a field-based role with office flexibility, where you will serve as the primary guardian of data integrity, protocol compliance, and patient safety at investigative sites across China. You will play a critical hands-on role in the execution of clinical trials, directly contributing to the development of innovative therapies for patients.
We are seeking an experienced, independent CRA to manage the complete site monitoring lifecycle. If you are passionate about scientific rigor, excel in building collaborative site relationships, and thrive in a dynamic environment, this is your opportunity to accelerate your career with a global industry leader.
🎯 Your Site Management & Monitoring Mission: Key Responsibilities
End-to-End Site Oversight & Visits
- Conduct the full cycle of site management visits: site qualification, initiation, routine monitoring, and close-out visits in full compliance with ICH-GCP, local regulations (NMPA), and study protocols.
- Serve as the primary point of contact for assigned investigative sites, building strong, professional relationships with investigators and site staff to ensure smooth study conduct.
Data Integrity & Patient Safety Vigilance
- Perform comprehensive source data verification (SDV) and meticulous review of case report forms (eCRFs/CRFs) to guarantee the accuracy, completeness, and consistency of all clinical data.
- Verify the ongoing protection, rights, and well-being of study participants and ensure all site activities adhere to the approved protocol and ethical standards.
- Proactively identify, document, and resolve site issues, deviations, or non-compliance, ensuring timely and effective corrective actions.
Documentation Excellence & Regulatory Stewardship
- Contribute to the preparation, review, and finalization of essential study documentation, including protocols, clinical study reports (CSRs), and monitoring visit reports.
- Ensure the complete collection, review, and maintenance of all essential regulatory documents in the Trial Master File (TMF) to maintain constant audit and inspection readiness.
- Support sites with regulatory and safety reporting obligations, including the management of Serious Adverse Event (SAE) reporting processes.
Collaboration, Training & Communication
- Collaborate effectively with internal cross-functional teams, including Clinical Project Managers, Data Management, and Safety, to ensure aligned study progress and rapid issue resolution.
- Train and support site staff on the study protocol, procedures, GCP, and electronic data capture (EDC) systems.
- Maintain clear, professional, and timely communication with all stakeholders.
⭐ Your Profile: CRA II Qualifications & Expertise
Essential Requirements
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Medicine, or a related healthcare/scientific field.
- Minimum of 2 years of independent, on-site Clinical Research Associate (CRA) monitoring experience within a CRO, pharmaceutical, or biotechnology setting.
- In-depth, practical knowledge of clinical trial processes, ICH-GCP guidelines, and relevant Chinese regulatory requirements (NMPA).
- Fluency in Mandarin and professional proficiency in English (written and verbal) are mandatory.
- Ability to travel approximately 60% of the time (domestic and potentially international), possessing a valid driver’s license.
Core Competencies
- Proven Site Management Skills: Demonstrated expertise in managing all stages of site engagement and remote monitoring activities.
- Analytical & Detail-Oriented: Strong analytical skills with an unwavering focus on data quality and meticulous attention to detail.
- Regulatory Acumen: Solid understanding of clinical trial documentation standards and regulatory compliance in China.
- Technical Proficiency: Hands-on experience with clinical technology systems (CTMS, EDC, eTMF).
Professional Attributes
- Excellent Organizational Skills: Ability to independently manage multiple sites, priorities, and deliverables in a fast-paced environment.
- Superior Communication & Interpersonal Skills: Ability to build trust, influence, negotiate, and resolve issues effectively with diverse stakeholders.
- Proactive Problem-Solver: Self-motivated, resourceful, and capable of anticipating risks and implementing practical solutions.
- Collaborative Team Player: Works effectively as part of both local and global virtual teams.
💫 Why Build Your Monitoring Career at ICON in Shanghai?
Impact Drug Development in a Critical Market
- Play a direct, hands-on role in executing cutting-edge clinical research that brings new therapies to patients in China.
- Ensure the highest standards of ethical conduct and data quality, which are foundational to successful regulatory submissions and approvals.
Career Growth & Professional Development
- Clear career progression pathway to Senior CRA, Lead CRA, and Clinical Team Lead roles.
- Exposure to a diverse portfolio of studies across multiple therapeutic areas and phases.
- Continuous professional development through structured global and local training programs and mentorship.
Flexible & Supportive Work Model
- Office with Flexibility: Benefit from a local office hub in Shanghai with a flexible working model that supports a balance of field-based and remote responsibilities.
- Comprehensive Support: Receive strong backing from dedicated line management, robust internal processes, and a collaborative local and international team.
- Inclusive Culture: Join a diverse and dynamic team where inclusion, belonging, and innovation are core to our values.
Competitive ICON Benefits in China
- Attractive salary and performance-based bonus incentives.
- Comprehensive benefits package including health, dental, and life insurance.
- Generous paid time off and company holidays.
- Retirement savings plan.
- Travel allowance and home-based office setup support.
- Global Employee Assistance Programme (EAP) providing 24/7 confidential support for you and your family.
- Ongoing investment in your career growth through training and development allowances.
✨ Ready to Ensure Excellence at Clinical Sites Across China?
If you are a dedicated, travel-ready monitoring professional passionate about upholding the highest standards in clinical research, we encourage you to apply. This CRA II role in Shanghai offers a unique opportunity to be at the forefront of clinical development, ensuring the integrity of trials that transform patient care in China and worldwide.
Apply Now and become ICON's next key expert in clinical trial monitoring and site management in Shanghai.
