职位描述：

1. 通过规范的监查过程，保证临床试验按国家GCP要求和试验方案进行；

2. 试验用药物和物品的正确保管、发放和使用；

3. 填写相关报告及试验记录，确保数据真实准确、完整无误。

任职要求：

1. 临床医学或医药学相关专业，本科及以上学历；

2. 一年以上CRA工作经验；

3. 熟悉药品注册管理办法、药品临床试验及GCP等相关法规；

4. 英语水平CET-4 或CET-6，具有良好的英文读写及口语能力；

5. 有良好的人际关系和良好的沟通及语言表达能力；

6. 能够适应经常出差。

RESPOIBILITIES

？ CRA is respoible for clinical research tasks relating to the sites in charge, conducted in CMIC

such as monitoring, filing and reporting.

？ CRA is respoible to confirm that the assigned study is conducted in line with the relevant

regulatory requirements/procedures, e.g. applied GCP, local regulatiorules, SOP.

？ CRA shall play a role of an intermediate among CMIC, investigator and spoor.

？ CRA shall report on something like progress of the study, to PM, CPLub-CPL, CR Manager.

REQUIREMENT

? Must be certified as a CRA in compliance with SOP.

? Familiar with all the regulatory guidelines and procedures such as ICH/local GCP, SOPs etc.

? Knowledgeable with the information of study drug such as investigational brochure and with

all requirements of the protocol.

? Ability to work in a team environment.

? Clear & professional written & oral communication.

? Good interpeonal skills

? Business level English skill for the multi-national project