前言
大家好,我是临研圈内容合作官Daisy Lin,进入行业已经快5年了,现在某Global CRO 公司做SCRA的工作,很荣幸能够和临研圈合作,借助这样的平台和大家分享一些我认为有意思的文章,初步设想日后主要分享的方向分两种:1)一些行业的专业知识,尤其是我个人的一点点经验;2)我看到的一些有意思的文章。
前段时间是校招的高峰,回想5年前自己懵懵懂懂的就进入了这一行,当然这是说好听的,真实的原因其实是医院没进去,一是没关系,二是学历也不够,对于念书、考试真的是够够的,所以才误打误撞进入了这一行。
但现在其实还蛮庆幸的,选对了行业!身边也有很多医院的朋友跳出来从事这一行,如下是看到的国外一篇文章,原文标题是《Clinical Research Associate Career Overview and Outlook》,基于个人感受,换了一个标题《CRA,一份医药行业内不错的职业选择》,希望给学弟学妹们在职业选择方面带来一点帮助。
临床监查员(CRA)曾被CNN评为“美国最好的工作”之一。在2012年,这份工作在CNN列出的100个最佳工作中排名第四。是什么让这份工作如此令人向往?虽然去年没有进入CNN的榜单,但CRA这一工作,也被称为临床监查员或试验监查员,仍然有很多值得热爱的地方。The role of a clinical research associate (CRA) was once named by CNN as one of the "Best Jobs in America." In fact, in 2012, the job was fourth on a list of 100 top jobs according to CNN. What makes this profession such a desirable one? Although it didn't make the CNN list last year, there is still a lot to love about a career as a clinical research associate, which is sometimes referred to as a clinical monitor or trial monitor.
因为有着可观的收入和良好的前景,CRA工作成为了一个极好的职业选择。根据Indeed.com的数据,截至2015年8月31日,CRA的平均工资为9.5万美元,有些人的工资超过12.5万美元。A competitive income and a strong outlook for clinical research associates make working as a CRA a great career choice. According to Indeed.com, the average salary for CRAs as of August 31, 2015, is $95,000, but some earn over $125,000.
据美国劳工统计局(Bureau of Labor Statistics)预计,2012年至2022年的10年里,薪资增长率将高于平均水平,至36.4%。Growth is projected to be stronger than the average job, at 36.4% in the ten year period from 2012-2022, according to the Bureau of Labor Statistics.
临床研究试验是帮助测试和验证药物、医疗设备、治疗特定疾病或特定条件下的程序是否具有有效性和安全性的研究,CRA在这些研究的推进和管理中发挥着不可或缺的作用。linical research trials are studies which help to test and verify the efficacy and safety of a pharmaceutical, medical device, or procedure for treating a given illness or condition, and clinical research associates play an integral role in conducting and controlling these studies.
为了更多地了解CRA的角色,我们向临床研究行业专业人士Dan Sfera请教。Sfera是Clinical Trials Guru公司和DSCS Sweat Equity & Investments公司的CEO兼总裁,该公司为申办方和临床研究组织(CRO)提供选址、研究人员培训、招聘、合同谈判、预算和业务开发服务。To learn more about the role of clinical research associates, we turned to Dan Sfera, a clinical research industry professional, for more insight. Sfera is the CEO and president of The Clinical Trials Guru, LLC, and DSCS Sweat Equity & Investments, LLC, through which he assists sponsors and clinical research organizations (CROs) with site selection, research staff training, recruitment, contract negotiatio.
Q1:CRA的一天是怎样的?Dan Sfera:每一天都不一样。通常每周的工作时间是60小时,70%的时间是在全国各地的研究机构中度过的。工作任务包括审查研究的源数据,并将其与EDC系统进行比较,查询并帮助研究人员处理数据差异或者与研究参与者的整体利益相关的事项。Every day is different. The typical work week is 60 hours and about 70% of the time is spent "onsite" at various research clinics throughout the country. Tasks include reviewing source data for the studies as well as comparing it to the EDC systems. Issuing queries and helping research staff solve any discrepancies either in the data or for the overall well being of the study participant.
Q2:成为CRA需要什么学历?要参加哪些培训?Dan Sfera: 通常需要学士学位,最好是在科学相关的研究领域,但这不是必须的。此外,还需要参加GCP培训。Usually a bachelor's degree is required, preferably in a science-related field of study, but not absolutely necessary. GCP training will also be needed.
Q3:什么类型的公司需要聘用CRA?Dan Sfera: CRO公司(临床研究公司),那些大型国际公司,很多已经上市了。CROs (clinical research organizations). They are huge multinational organizations that are often publicly traded.
Q4:CRA应该了解公司的哪些方面?Dan Sfera: CRA应该了解公司的培训、升职空间、工作量、出差时间,以及他们可以参与哪些领域的研究。 Clinical research associates should look for training, ability to get promoted, workload, amount of time required to travel, as well as what therapeutic indication studies they can work on.
Q5:公司希望CRA具备哪些条件?(技能资质等)Dan Sfera: 这些都需要。但大多数机构真正重视的一个条件是招募病人的技巧或招募经验。医疗志愿者的经历对应聘也有帮助。All of the above. One desirable qualification that most sites really need is patient recruiting skills or recruiting experience. Any healthcare volunteer experience helps too.
Q6:CRA工作最受人们喜爱的是哪个方面?Dan Sfera: 每一天都是不一样的。此外,这份工作还提供了很多外出,以及结识新朋友的机会。此外,临床研究是一份相对稳定的工作,这个行业的专业人士几乎总是供不应求。No day is the same as the last. Also, the job offers lots of travel, as well as opportunities to meet with new people. Additionally, clinical research is a relatively stable job, and professionals in this industry are almost always in demand.
Q7:CRA面临的最大挑战是什么?Dan Sfera: 工作与生活的平衡。四个星期有三个星期都在路上,工作量非常大。Work-life balance. Being on the road three out of every four weeks. Extreme workloads.
Q8:CRA工作的前景(市场需求)怎么样?Dan Sfera: CRO行业是个不断发展的行业,所以各公司都一直在招人,CRA的需求是很高的。The CRO industry is a growth industry, so they are always hiring, and demand for CRAs is high.
Q9:CRA有什么其他的职业发展方向?Dan Sfera: CRA有机会可以晋升为项目经理或临床试验负责人。Project manager or clinical trial lead are two roles that offer advancement for clinical research associates.
译者介绍
Daisy 某知名外资CRO公司SCRA
拥有5年临床监查经验
话题:
当身边的年轻人面临择业时,你愿意推荐他/她从事CRA工作吗?
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