Clinical Research Associate I/II/ Senior - C1 - Shanghai
On-site · Shanghai, Shanghai, China
Job Summary
Oversee monitoring and management of investigator sites, perform source data verification (SDV) and ensure timely data submission to data management; ensure patient safety reporting aligned with regulatory requirements; proactively manage site workload to meet study objectives; ensure compliance with ICH-GCP, SOPs, and local laws; train site staff on the protocol and client processes; maintain site master files and trial master files; generate site monitoring reports and ensure timely documentation in ELARA/TMF; collaborate with Principal Investigator and site staff to resolve issues and implement corrective actions; demonstrate strong communication in Chinese and English, ability to multitask, and adaptability to a matrix environment; maintain up-to-date knowledge of product, protocol, and therapeutic area to support investigator discussions.
Required Qualifications
- Bachelor’s degree or above in Life Science, Nursing, Pharmacy, or other relevant education background
- At least 1.5 years (2 years preferable) of Clinical Monitoring/Site Management experience; global study monitoring experience preferred
- Proficiency in Chinese; strong command of written and spoken English
- Understanding of ICH-GCP, local and international regulatory requirements relevant to Clinical Research
- Ability to train site staff on protocol, amendments, and client processes
- Ability to manage multiple tasks with attention to detail and work in a matrix environment
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