Clinical Research Associate Specialist

5 days ago


Petaling Jaya, Selangor, Malaysia Parexel International Full time
Job Description

The Clinical Research Associate I will be responsible for managing clinical trials from site identification to close out. The role involves acting as Parexel's direct point of contact with assigned sites, ensuring overall integrity of study implementation and adherence to study protocol at clinical sites.

Key Responsibilities:
  • Site Identification and Qualification:
  • Conduct remote qualification visits (QVs) and generate visit/contact reports.
  • Build relationships with investigators and site staff.
  • Evaluate site feasibility and perform country-specific feasibility and/or site pre-qualification activities.
Maintenance and Monitoring:
  • Clinical Trial Management:
  • Ensure timely and accurate completion of project goals and update applicable trial management systems.
  • Manage and submit all relevant documents to the Trial Master File (TMF), ensuring first-time quality.
Compliance and Quality:
  • GCP Compliance:
  • Maintain compliance with ICH-GCP and applicable international and local regulations.
  • Assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites.


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