公司简介
"DOCS is a division of ICON plc that provides global staffing solutions to ICON as well as to Pharmaceutical, Biotechnology, Medical Device companies and CROs in over 39 countries. ICON has been in APAC since 1996 and the DOCS division of ICON is now expanding in the APAC region.
We are a specialist recruitment division recruiting in Clinical Research, Medical Affairs, Regulatory Affairs, Drug Safety, Health Economics, Data Management & Statistics, and Quality Assurance etc. We can recruit in virtually any location having access to offices in over 25 countries. This truly makes DOCS a company with global reach and personal focus.
The role
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.