Clinical Research Associate II(FSP)- GZ
On-site · Guangzhou, Guangdong, China
Job Summary
Clinical Research Associate II (FSP) at Parexel in Guangzhou monitors investigator sites, conducts SDV, identifies and resolves issues, ensures trials comply with ICH-GCP and SOPs, maintains patient safety and regulatory reporting, collaborates with Principal Investigator and site staff, trains site personnel on protocol and processes, manages site set-up to close-out, ensures timely data entry and data quality, generates site monitoring reports, and maintains Investigator Initiation Packages and TMF/ELARA documentation. Requires a Bachelor’s degree in Life Science, Nursing, or Pharmacy (or equivalent), 1.5–2 years of clinical monitoring/site management experience (global study monitoring preferred), and proficiency in Chinese with good English communication skills.
Required Qualifications
- Bachelor's degree in Life Science, Nursing, Pharmacy, or related field or equivalent
- 1.5-2 years of Clinical Monitoring/Site Management experience (global study monitoring preferred)
- Proficiency in Chinese; good command of written and spoken English
- Strong interpersonal and communication skills
- Ability to manage multiple tasks and prioritize workload
- Willingness to work in a matrix environment and value teamwork
- Understanding of ICH-GCP and applicable regulatory requirements
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