面试外企最担心的就是自己的英语,CRA应该如何在日常工作中提高自己的英语能力是很多小伙伴都关心的问题。
今天就详细跟大家分享一下CRA如何学习英语,尤其是临床试验专业英语的方法和途径。
如果你问CRA想要学习英语有没有什么推荐的书籍,那么ICH-GCP是就是必看必读的,甚至重点的段落和表达应该背诵下来。重点跟大家分享下怎么通过ICH-GCP学到专业的英文表达。
1) CRA的职责:首先我们要掌握CRA那么多的工作职责应该怎么用英文表述,而不是直接把网上搜到的JD有道翻译一下。
以下来自ICHGCP5.18.4 Monitor's Responsibilities
(a) Acting as the main line of communication between the sponsor and the investigator.
CRA代表的是申办方,也是申办方和研究者之间一个沟通的桥梁。
(b) Verifying that the investigator has adequate qualifications and resources and these remain adequate throughout the trial period, that facilities including laboratories and equipment, and staff, are adequate to safely and properly conduct the trial and remain adequate throughout the trial period.
CRA需要确认研究者的资质,并且确保研究中心有足够多的资源开展试验。这个表达就可以用到SSV流程里面。因为做中心筛选,CRA需要去评估评估site的承接能力,研究者以及研究团队的资质。
这句话里面我们重点要掌握的词汇有:qualifications(表达资格资质), facilities(当我们想表达试验物资/设备时),site staff(表达研究团队时)。
(c) Verifying, for the investigational product(s):
试验药物用investigational product 来表达,而不要翻译为test drug.
(d) Verifying that the investigator follows the approved protocol and all approved amendment(s)
确保研究者遵循方案。掌握approved protocol and all approved amendment(s)来表达经过批准的方案和方案修订案(protocol amendment)。
(e) Verifying that written informed consent was obtained before each subject's participation in the trial.
确保受试者在参与试验之前签署了知情同意书。如果英文面试问到How to check ICF?那么这句话就是回答的点之一。
(i) Verifying that the investigator is enrolling only eligible subjects.
确认受试者的入排是否符合方案要求。掌握入组enroll(enrollment)以及eligible subjects(符合入排的受试者)。
(j) Reporting the subject recruitment rate.
掌握subject recruitmen(受试者招募),在回答促进入组或者招募受试者的问题时我们可能会提到招募广告(recruitment advertisement).
(k) Verifying that source documents and other trial records are accurate, complete, kept up-to-date, and maintained.
确认原始数据记录的准确,完整,及时性。掌握source documents(源数据),maintain这个单词也是出现频率很高的,比如我们想说管理研究者文件夹不一定只能用manage ISF binder, 可以用maintain ISF binder.SDV=source data verification, ISF=investigator site file.
(m)Checking the accuracy and completeness of the CRF entries, source documents and other trial-related records against each other. The monitor specifically should verify that:
(i) The data required by the protocol are reported accurately on the CRFs and
are consistent with the source documents.
(ii)Any dose and/or therapy modifications are well documented for each of
(iii)Adverse events, concomitant medications and intercurrent illnesses are
reported in accordance with the protocol on the CRFs.
(iv) Visits that the subjects fail to make, tests that are not conducted, and
examinations that are not performed are clearly reported as such on the
(v) All withdrawals and dropouts of enrolled subjects from the trial are
reported and explained on the CRFs.
以上表达可以用于回答How to perform SDV?
(o) Determining whether all adverse events (AEs) are appropriately reported within the time periods required by GCP, the protocol, the IRB/IEC, the sponsor, and the applicable regulatory requirement(s).
当想表达按照方案,GCP和机构伦理的要求报告的时候。可以使用
within the time periods required by GCP, the protocol, the EC(中国一般用GCP office/EC)。
(q) Communicating deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator and taking appropriate action designed to prevent recurrence of the detected deviations.
发生PD后要采取措施避免再次发生。掌握to prevent recurrence of the detected deviations的表达。
(2)综上,强烈建议大家把ICHGCP5.18.4 Monitor's Responsibilities的内容背诵并灵活运用,当然不只是这个部分,ICHGCP里面还有很多值得学习的词汇和表达,就不一一例举了。
比较推荐的网站是YouTube和B站。大家可以直接搜BEC商务英语跟读,每天听一听,磨磨耳朵,记录一些常见的表达。
I am .../ I work as ...for...
I am work as an CRA for a CRO company.
I am responsible for site selection, GCP and EC submission, site initiation, monitoring and site close out visits.
I am in charge of marketing department.
I joined for the company when I was 25 and have work there ever since.
I am going to leave the company at the end of the year.
I have one day off a week to attend a course at college.
轻言英语,流利说,英语魔方秀。可以练习自己的发音。
最后,关于CRA相关的英语,大家可以关注YouTube Up: CGP-Mindset,Dan Sfera。平常也可以看看美剧,不过自从做了CRA基本上不怎么看美剧了,就不做推荐了。
网上免费的学习资源还是很多的,不过需要花点时间查找。
最后就是关于很多小伙伴问的考证问题,比如要不要考雅思,要不要考BEC。答案是不一定,求职招聘的时候更看重你在面试中的口语表现,同时国内目前大部分的CRA岗位并没有对口语要求非常流利,也没有要求全英文面试,掌握常见的面试问题基本上就可以应付面试了(参考公众号的面试文章,虽然有些回答的内容不是很全面但是准备简单的英文面试是够了的)。
当然,有时间且愿意花钱的小伙伴是可以去考证的,同时学习英语的过程,尤其是付费学习更能加强自制力,能学到东西,对于长远来看还是有帮助的。
梧桐雨,专注于CRA求职,面试经验,干货分享,药研社内容合作官。
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