đ Champion Clinical Trial Excellence: 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 pivotal field-based role with office flexibility, where you will be the primary guardian of data integrity and patient safety at investigative sites. You will ensure the flawless execution of clinical trials, directly contributing to the advancement of innovative treatments for patients in China and beyond.
We are seeking an experienced and independent CRA to manage the complete site monitoring lifecycle. If you are driven by scientific rigor, excel in building collaborative site relationships, and are passionate about upholding the highest standards of clinical research, this is your opportunity to grow your career with a global industry leader.
đŻ Your Monitoring & Site Management Mission: Key Responsibilities
End-to-End Site Oversight
- Conduct all aspects of site management visits:Â qualification, initiation, monitoring, and close-out, ensuring strict adherence to protocols, ICH-GCP, and local regulations.
- Serve as the primary point of contact for assigned investigative sites, building strong, collaborative relationships with investigators and site staff to facilitate smooth study conduct.
Data Integrity & Patient Safety Vigilance
- Perform source data verification (SDV) and review case report forms (eCRFs/CRFs) to ensure the accuracy, completeness, and consistency of clinical data.
- Verify the protection of study participants and that all site activities are conducted according to the approved protocol and ethical standards.
- Proactively identify, document, and resolve site issues, deviations, or non-compliance, ensuring timely corrective and preventive actions.
Documentation & Regulatory Compliance
- Contribute to the preparation and review of essential study documentation, including protocols, clinical study reports (CSRs), and monitoring visit reports.
- Ensure the collection, review, and maintenance of all essential documents in the Trial Master File (TMF) for complete audit readiness.
- Support sites with regulatory and safety reporting requirements, including Serious Adverse Event (SAE) reporting processes.
Collaboration & Communication
- Collaborate effectively with internal cross-functional teams, including Clinical Project Managers, Data Management, and Safety, to ensure aligned study progression.
- Train and support site staff on study protocols, procedures, GCP, and electronic data capture (EDC) systems.
â Your Profile: CRA II Expertise
Essential Qualifications
- Bachelorâs degree in Life Sciences, Pharmacy, Nursing, 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 company.
- In-depth knowledge of clinical trial processes, ICH-GCP guidelines, and relevant Chinese regulatory requirements (NMPA).
- Fluency in Mandarin and professional proficiency in English are required.
Core Competencies
- Proven Site Management Skills:Â Demonstrated expertise in the full site visit cycle and remote monitoring activities.
- Data Quality Focus:Â Strong analytical skills with meticulous attention to detail for data review and query resolution.
- Regulatory Acumen:Â Solid understanding of clinical trial documentation and regulatory compliance in China.
- Technical Proficiency:Â Experience with clinical technology systems (CTMS, EDC, eTMF).
Professional Attributes
- Excellent Organizational Skills:Â Ability to manage multiple sites and priorities independently in a fast-paced environment.
- Superior Communication & Interpersonal Skills:Â Ability to build trust, negotiate, and resolve issues effectively with diverse stakeholders.
- Proactive Problem-Solver:Â Self-motivated with the ability to anticipate risks and implement solutions.
- Collaborative Team Player:Â Works effectively as part of a local and global team.
đŤ Why Build Your Monitoring Career at ICON in Shanghai?
Accelerate Drug Development in China
- Play a direct, hands-on role in bringing cutting-edge clinical research and new therapies to patients in one of the world's most critical markets.
- Ensure the highest standards of data quality and ethical conduct, which are foundational to successful regulatory submissions.
Career Growth & Global Exposure
- Clear career progression pathway to Senior CRA, Lead CRA, and Clinical Team Lead roles.
- Exposure to a vast portfolio of studies across diverse and innovative therapeutic areas.
- Continuous professional development through structured global and local training programs.
Work with Flexibility & Support
- Office with Flexibility:Â Enjoy the benefits of a local office hub with a flexible working model that supports field-based responsibilities.
- Supportive Environment:Â Receive comprehensive support from dedicated line management, robust internal processes, and a collaborative local team.
- Inclusive Culture:Â Join a diverse team where inclusion and belonging are fundamental 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.
- Car allowance and home-based office setup support.
- Global Employee Assistance Programme (EAP) providing 24/7 confidential support.
- Ongoing investment in your professional development.
â¨Â Ready to Uphold the Highest Standards at Shanghai's Leading Clinical Sites?
If you are a dedicated monitoring professional passionate about data integrity, patient safety, and scientific advancement in the China region, we encourage you to apply. This CRA II role in Shanghai offers a unique opportunity to be at the forefront of clinical research, ensuring excellence at every site visit for trials that transform patient care.
Apply Now and become ICON's next guardian of clinical trial quality and compliance in Shanghai.
