临床监查员CRA2-FSP

The CRA is to verify that the rights and well-being of human subjects are protected. The reported trial data are accurate, complete, and verifiable from source documents. The conduct of the trial is in compliance with the currently approved protocol/ amendment(s), with GCP, and with the applicable regulatory requirement(s). Develop and maintain collaborative relationships with the investigational sites Support the task at study level and will take a lead role where required. For CRA who takes Site Monitoring Lead(SML) role, he/she should provide operational expertise to the trial team on the site monitoring approach for the trial. Oversee the implementation of the site monitoring approach. Provide and maintain oversight and guidance related to site monitoring activities throughout the course of a trial, to safeguard the protection of the trial subject, reliability of the trial results, compliance with study protocol, ICH-GCP and applicable regulations and ensure inspection readiness at all times. He/she may develop expertise and capabilities as a SML guided by a mentor (experienced SML) and/or for trials with small scope (i.e. limited geographical spread) and low complexity which are conducted in accordance with the BI standard processes and procedures.

任职要求：