Research Professional

4 days ago


Taipei, Taiwan beBeeClinical Full time
Job Title: Clinical Research Associate II

 

Job Description:

This position is responsible for managing clinical studies and conducting site monitoring responsibilities in accordance with Fortrea's Standard Operating Procedures (SOPs), ICH guidelines, and GCP.

  • Verify study training records and ensure informed consent procedures and protocol requirements are adhered to according to applicable regulatory requirements.
  • Conduct source document review, source document verification, query generation, and resolution against established data review guidelines on Fortrea or client data management systems.
  • Ensure audit readiness at site level and guarantee the study Investigational Product inventory and accountability is accurate.
  • Act in the project role of a Lead CRA as assigned.

 

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

 

Benefits:

The ideal candidate will possess excellent planning, organization, and problem-solving abilities and work efficiently and effectively in a matrix environment.

  • Good attention to detail.
  • Methodical approach to work.
  • Good understanding of medical and clinical research terminology and clinical research processes.

 

Others:

Please note that travel requirement is 60% of the time (traveling to study sites).

 

To apply, please visit our website.



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