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新加坡商艾得克有限公司台灣分公司 - CRA

http://bit.ly/1TmJrs4



工作說明:


The responsibility of a Clinical Research Associate (CRA) is to perform the clinical monitoring aspect of designated projects in accordance with applicable SOP and regulations.

? Oversees the progress of a Clinical Trial, ensuring that it is conducted, recorded and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and the applicable Regulatory requirements.

? Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, initiation visits, liaise with vendors, and other duties as assigned

? Responsible for all aspects of site management according to the study plans

? Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs

? Independently perform Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on the data management systems as assigned by management.

? Submissions preparation, notifications to EC/IRB, translation of study-related documentation, and other tasks as prescribed in the project plans.



工作地點:


台北市信義區


工作時間:


日班


休假制度:


週休二日


工作性質:


中高階


職務類別:


生技主管醫藥行政管理人員


工作待遇:


面議


需求人數:


1人


到職日期:


不限


職缺更新:


2015/12/28






求才條件





身份類別:


不拘


學歷限制:


不拘


科系限制:


不拘


工作經驗:


5年以上工作經驗


附加條件:


- CRA工作經驗1Y以上.




新加坡商艾得克有限公司台灣分公司 - CRA





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