公司简介
The responsibilities of the Clinical Research Associate include, but are not limited to:
• Act as the main line of communication between the sponsor and the investigator
• Verifying that all research staff, facilities and investigational products have adequate qualifications and resources and these remain adequate throughout
• Responsible for the safety and proper conduct throughout the trial
• Verifying that the investigator follows the approved protocol and all GCP procedures
• Verifying that source data/documents and other trial records are accurate, complete, and maintained
• Adverse events, concomitant medications, and inter current illnesses are reported in accordance with the protocol on the CRFs
• Experience should include monitoring skills. Prior relevant active independent field monitoring experience and site management experience
What you need
• Experience should include monitoring skills. Prior relevant active independent field monitoring experience and site management experience
• Strong knowledge in ICH-GCP
• Ability to review and evaluate clinical data
• Computer literacy desirable
• Professional use of the English language; both written and oral
• Good oral and written communication skills
• Due to the nature of this position it may be required for the employee to travel
• Bachelor degree, or local equivalent, in medicine, science or related discipline
• Oncology study & global study experience is highly preferred.
Experience requirements
For reference only
• 1~2 years CRA experience for CRA I.
• 2~3.5 years CRA experience for CRA II.
• More than 3.5 years CRA experience for SCRA.