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CRA面试常见问题汇总?监查员有那些职责：?一、试验准备?确认sites具备实施试验的条件：人员配备和培训，设备齐全，病源充足，研究者熟悉试验用药品、临床方案和相关文件?二、试验开始?1）制订访视计划?2）确认受试者签署ICF，了解入组现状和试验进展，?3）SDV：确认试验数据和CRF填写的真实、完整、准确，原始文件的保存4）确认AE和SAE记录并符合上报规定?5）试验用药品核查：是否按规定储存、分发和回收，并详细记录?三、试验结束?回收药品，保存试验资料，协助汇报试验数据和结果监查的目的：?1）确保试验遵循临床方案，GCP和相关管理法规?2）保障受试者的权益和安全?3）试验记录和报告数据真实、完整、准确，并与原始资料一致?试验中对试验用药品如何管理？试验用药品何时才允许发送到医院？?1）严格管理：保证仅供受试者使用，通过药品计数确保受试者的依从性。?2）专人专地：由主要研究者指定人员进行管理，详细记录药品（包括阳性对照品和安慰剂）的接收、发放、储存、回收及销毁情况。药品应保管在安全盒储存条件符合的地方。?双盲试验中，应保证药品的按随机编号顺序发放。?3）有效计数：试验结束后要求受试者归还剩余药品和已用药品的包装盒，以进行计数。?获得SFDA批文和IEC批文后，试验用药品才能发送到医院。?一般问题：?你认为作为CRA最重要的素质是什么？协调能力、原则性、体力、学习能力，最重要的是原则：严格按照方法、遵循法规和GCP来处理事情。我在药物安全的经验也验证了这一点，如果一点点不按照规章做事，则可能要浪费1-倍的时间去弥补。你如何定义优秀的CRA？?极高的情商、专业、原则，这需要努力和时间才能达到。是否参加过GCP培训? 2012年参加过CFDA的网络培训工作经验？（时间，曾经参与项目，收获，举例）？/please?briefly?introduce?yourself??in?english.? I am Zhang Jin, 27 year, I am science master major in biology and pharmacology. I have 2 years’ experience in a global pharmaceutical company as a drug safety specialist in medical team. During the 2 years, I learned a lot regarding drug safety and have worked with our clinical trial team, which I found I am interested in clinical trial operation and I want be a CRA. So I consider the Quitile CRA trainee is very suit for me. Is a good position for people without CRA experience and is a good company for personal career development. Why you think you are suit for CRA ?At first, I feel I like it. When I first time know this job in detail after I had been trained in CFDA GCP course and had read an article named To Be a CRA. I feel I like it.Then, I am a people good at logical thinking. I made a computer software in BMS for my team for processing the daily work. The computer software making is always need a good logical design. And I think the logical thinking is important for CRA and the communication with people.thirdly, I like challenge and complex thing. I enjoy the moment that I get those things done. I think CRA is a very challenge work. You have CRA 1,2,3. You have to wo