职位描述
职责描述:
· 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
任职要求:
· Strong knowledge in ICH-GCP
· Ability to review and evaluate clinical data
· Computer literacy desirable
· 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
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