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Parexel
Parexel
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Parexel is a global clinical research organization serving biopharmaceutical companies throughout the development of new medicines. Its work spans Phase I–IV clinical trials, portfolio and trial management, regulatory strategy, market access, and lifecycle planning. With more than 21,000 professionals, Parexel combines clinical, regulatory, and therapeutic expertise with patient insights and innovative trial designs. The company supports research across areas including oncology, neuroscience, and rare diseases, with a focus on making clinical development more efficient and patient-centered.
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Clinical Research Associate II – China (Remote)

Parexel is seeking a Clinical Research Associate II to monitor investigator sites and clinical trial data in China remotely. The role focuses on ICH/GCP compliance, patient safety, accurate documentation, and study quality.

CNChinaRemoteFull-timeJuniorMiddleEnglish RequiredChinese RequiredClinical Research
Google Cloud Platform

Description

  • Perform source data verification and ensure clinical trial data reaches data management promptly
  • Identify study conduct issues and drive their appropriate resolution
  • Coordinate investigator site workloads to support efficient study delivery and objectives
  • Verify compliance with ICH/GCP, local regulations, and client standard operating procedures
  • Protect patient safety and report safety concerns in line with regulatory requirements
  • Communicate identified issues to principal investigators and site staff
  • Create corrective and preventive actions with investigators and site teams
  • Oversee sites from selection through study closeout
  • Train site personnel on protocols, amendments, and client procedures
  • Maintain current knowledge of the product, protocol, and relevant therapy area
  • Engage healthcare professionals while supporting client credibility
  • Confirm monitored data meets quality standards and is entered into client systems promptly
  • Document study progress after site visits and track issues through closure
  • Keep site-level clinical trial registry information accurate and current
  • Obtain and maintain Investigator Initiation Package, Site Master File, ELARA, and/or Trial Master File documentation
  • Perform quality control on relevant documents and maintain monitoring logs
  • Prepare site monitoring reports
  • Complete required training, timesheets, expense reports, and CV updates
  • Follow Parexel procedures, ICH-GCP, and all applicable requirements

Requirements

  • Comfortable using word processing, spreadsheet, and presentation software
  • Professional proficiency in Chinese
  • Strong written and spoken English skills
  • Effective interpersonal and communication abilities
  • Adaptable approach to assignments and new learning, with the ability to learn quickly
  • Ability to prioritize multiple varied tasks while maintaining close attention to detail
  • Willingness to work in a matrix structure and contribute to teamwork
  • At least 1.5 years of clinical monitoring or site management experience; 2 years is preferred
  • Working knowledge of ICH/GCP and applicable international and local clinical research regulations
  • Educational background in life sciences, nursing, pharmacy, or a related field
  • Bachelor’s degree or higher, or an equivalent qualification

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