Clinical Research Associate I(FSP) Coordinator

2 months ago


Beijing, Beijing, China Parexel Full time

Unlocking Success in Clinical Research

Our team at Parexel is dedicated to delivering exceptional results in clinical trials. As a Clinical Research Associate I(FSP), you will play a critical role in ensuring the success of our studies.

Key Responsibilities:

  1. Source Data Verification and Data Management Conduct thorough source data verification and ensure timely submission of clinical trial data to data management.
  2. Issue Identification and Closure Identify potential issues that may impact study conduct and work closely with site personnel to ensure appropriate closure of all issues.
  3. Site Management and Monitoring Proactively manage a greater investigator site workload, ensuring studies are run efficiently and key study objectives are met.
  4. Regulatory Compliance and Quality Ensure studies are conducted in line with ICH/GCP, local laws, and client standard operating procedures.
  5. Patient Safety and Reporting Maintain patient safety and report all safety issues correctly according to local and international regulatory requirements.
  6. Collaboration and Training Collaborate with site staff to ensure they are adequately trained on the protocol, protocol amendments, and client processes.
  7. Progress Reporting and Issue Management Report on study progress after each visit and proactively manage issues to closure.
  8. Documentation and Record-Keeping Maintain accurate site-level information on corporate clinical trials registry and ensure Electronic Library and Records Archive (ELARA) and/or Client Trial Master File (TMF) are complete and accurate.
  9. Compliance and Training Comply with required training curriculum, complete timesheets accurately, and maintain a working knowledge of Parexel processes and ICH-GCPs.


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