Chen Li Email & Phone Number

Shanghai

 Currently involved in 3 studies, 8 sites for regular site management activities Leading CRA for 2 NSCLC studies. Support global team to prepare Country level study documents.(Local inform consent, study specific using form) Support CRM to coordinates the local vendor. (local deport, central lab) Prepare local parched drug labeling , packaging and storage. Maintain trail document for CHINA level in e-TMF system. Tracking study recruitment status during all the time. Closely work with different function group during the study. ( such as Medical, DRA, Sourcing) Good Compliance Award in year 2014 GCP audit: satisfactory

Shanghai

 Involved in total 7 studies, 24 sites for regular site management activities Investigator meeting organization and arrangement. Coordinate IRB submission activities before, during and end of the study; Routine Monitoring visit(drive patient recruitment, implementation of study protocol, source data verification, drug accountability, data collection, issue and risk management); Build and maintain good and effective relationships with sites; Collect and review the regulatory documents; Set up and Maintain the Essential documents during the study;

Shanghai

 Received and process the Serious Adverse Event Report from United States of America Clinical Trial. Capture the key element information from SAE report General the query letter for the further information Follow the query letter until information complete