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Senior Clinical Trial Coordinator

1 week ago

Kuala Lumpur, Kuala Lumpur, Malaysia Fortrea Full time

**Job Summary:**

Fortrea is seeking an experienced Clinical Research Associate II to conduct site monitoring responsibilities for clinical trials. The ideal candidate will have a thorough understanding of ICH GCP Guidelines and local regulatory requirements.

Key Responsibilities:

  • Study Coordination:
  • Coordinate study activities with study staff and ensure compliance with protocol procedures.
  • Data Management:
  • Review source documents and verify accuracy against established data review guidelines.
  • Identify deficiencies, deviations, and discrepancies, and initiate corrective action as required.
  • Travel and Reporting:
  • Prepare and submit accurate and timely trip reports.
  • Travel, including air travel, may be required.

**Requirements:**

  • Qualifications:
  • University or college degree, or certification in a related allied health profession.
  • Thorough understanding of ICH GCP Guidelines and local regulatory requirements.
  • Basic understanding of the clinical trial process.
  • Fluent in English, both written and verbal.

Experience:

A minimum of 2 years of Clinical Monitoring experience.Ability to work with minimal supervision.