Clinical Research Associate II (FSP)

About the role

We are looking for a Clinical Research Associate II (FSP) to join Parexel’s clinical trial team. The CRA will be responsible for monitoring investigator sites, ensuring data quality, and supporting study conduct in accordance with ICH/GCP and local regulations.

Key responsibilities

• Monitor and manage investigator sites, performing source data verification and timely data submission.
• Identify, track, and close study issues, developing corrective and preventive actions with site staff.
• Ensure compliance with ICH/GCP, local laws, and Parexel SOPs, while maintaining patient safety and reporting adverse events.
• Train site personnel on protocols, amendments, and Parexel processes.
• Maintain site documentation, including Investigator Initiation Packages, Site Master Files, and trial master file records.
• Generate monitoring reports, update corporate trial registries, and communicate study progress to internal teams.
• Complete required training, timesheets, expense reports, and keep CV up‑to‑date.

Required profile

• Proficient in Chinese and fluent in written and spoken English.
• Strong interpersonal and communication abilities.
• Flexible attitude, quick learner, and able to manage multiple site workloads.
• Understanding of clinical research processes, ICH/GCP guidelines, and therapeutic areas.

Required skills

• Computer literacy: Microsoft Word, Excel, PowerPoint.
• Source data verification (SDV) experience.
• Regulatory compliance knowledge (ICH/GCP).