Drive clinical trial excellence from our Shanghai office. ICON is seeking an experienced Clinical Research Associate II (CRA) to manage and monitor clinical trial sites across China. In this office-based role with significant regional travel, you will be the frontline expert ensuring protocol compliance, data integrity, and patient safety, contributing directly to the advancement of innovative medical treatments in the Chinese market.
Key Responsibilities
You will be the primary point of contact for clinical trial sites, managing the end-to-end monitoring process to ensure successful study delivery.
Site Management & Monitoring:
- Conduct comprehensive site visits—from site qualification, initiation, and monitoring to close-out—ensuring adherence to protocol and Chinese regulatory requirements.
- Collaborate directly with investigators and site staff to build strong relationships and facilitate smooth study conduct.
- Perform source data verification (SDV), review case report forms (eCRFs), and resolve data queries to maintain the highest standards of data quality.
Compliance & Documentation:
- Ensure all site activities comply with ICH-GCP guidelines, Chinese regulatory requirements, and study protocols.
- Contribute to the preparation and review of essential study documents, including protocols, informed consent forms, and clinical study reports.
- Proactively identify and manage site-related issues, ensuring patient safety and data integrity are never compromised.
Your Profile
Essential Qualifications:
- Bachelor’s degree in a Life Science, Nursing, or a related healthcare field.
- Minimum of 2 years of experience as a Clinical Research Associate (CRA) with independent monitoring experience in China.
- In-depth knowledge of clinical trial processes and ICH-GCP guidelines.
Logistics & Skills:
- Ability to travel approximately 60% of the time within China and possess a valid driver’s license.
- Excellent communication and interpersonal skills, with the ability to work both independently and as part of a global team.
- Strong organizational skills with meticulous attention to detail.
- Proactive problem-solver who thrives in a fast-paced, dynamic environment.
Why Join ICON?
Our success depends on our people. When you join ICON, you become part of a team dedicated to excellence and innovation in clinical development. We offer:
- Competitive salary and a comprehensive benefits package focused on well-being.
- Office-based role with regional travel opportunities.
- Health insurance and competitive retirement planning.
- Global Employee Assistance Programme and extensive well-being support.
- A diverse, inclusive culture that rewards high performance and nurtures talent.
Ready to shape the future of clinical development in China? We encourage you to apply even if you don't meet every single requirement. Your unique experience could be exactly what we're looking for.
