作为临床研究人员，我们经常听说GCP，HIPAA，合规，监查，联邦法规（CFR）等等。As clinical research professionals, we often hear about GCP, HIPAA, compliance, monitoring, Code of Federal Regulations (CFR), so on and so forth.
当我们争取晋升时，我们会关注自己的临床研究技能，比如促入组、按时锁定试验数据库或通过FDA核查。When trying to secure that next promotion, we often focus on our clinical research skills: the ability to enroll a trial fast, locking that trial database on schedule or passing the FDA audit.
但我们很少退一步去思考软技能。如今，软技能比以往任何时候都更重要，忽视它们太危险了。Rarely we take a step back and think about soft skills. Today soft skills are more important than ever. It would be too dangerous to ignore them.
在这篇文章中，我将分享我在临床研究领域最喜欢的25项软技能。你也可以在生活的各个方面利用这些软技能。In this post, I’ll share my top 25 favorite soft skills in a clinical research context. You can leverage these soft skills in all areas of your life as well.
我们开始吧 So let’s get started:
1适应不断变化的需求
全球化和一致化持续改变着临床研究领域。例如，在医疗设备领域，人们谈论最多的变化是欧洲MDD，关于这个话题有很多议论(也有很多抱怨)。Globalization and harmonization continue to change the clinical research landscape. For example, in the medical device world, the most talked about changes are European Medical Device Directive (MDD). There is a lot of buzz on this topic (and complaining too).
去年我参加了BSI集团举办的为期一天的路演。演讲者请读过MDD草案的观众请举手。100多名观众中，只有不到5人举手。这足以说明观众的准备是多么不足。很少有人花时间去理解MDD的修改，但大多数人都很关注这些修改对工作的影响。Last year I attended a one day roadshow hosted by BSI Group. The presenter asked people to raise their hands if they had read the draft MDD. Less than 5 people in a room of 100+ attendees raised their hands. This goes to show how underprepared the audience was. Very few people had invested the time to understand the proposed changes to the MDD. Yet most of us we anxious about how the change was going to impact our work.
你必须问自己这样一个问题:“我将如何适应这些变化?”改变并不局限于政府法规，你的部门，角色，或者项目都会有意想不到的变化。花一些时间去静静地理解变化，然后去适应吧。The question you must ask yourself “how will I adapt to these changes?” Change is not limited to government regulations. You’ll experience unanticipated changes in your department, your role, or on your project. Take some quiet time to understand change and then adapt.
改变总是困难的，因为它迫使我们打破旧的习惯，形成新的习惯。Change is always hard because it forces us to break our old habits and form new habits.
2诚信和坚持 保持诚信和坚持是很难的。Being authentic and consistent is hard work.
比如，假设你是CRA，负责中心监查，你可能希望CRC及时回复你的电子邮件、回答开放性问题和完成数据录入。当你去中心访视时，你希望CRC微笑着接待你。For example, if you are CRA responsible for on-site monitoring, you probably expect the research coordinator to respond to your emails, answer open queries and complete data entry in a timely manner. When you visit the site, you want the research coordinator to welcome you with a smile.
但是作为CRA，你一样有责任保持诚信和坚持。你需要到中心进行访视，在访视后的几天内(而不是几周或几个月)发送监查报告，准确并友好地回答CRC的问题。For example, if you are CRA responsible for on-site monitoring, you probably expect the research coordinator to respond to your emails, answer open queries and complete data entry in a timely manner. When you visit the site, you want the research coordinator to welcome you with a smile.
我们很多人都看不到天平的另一边，尤其是在我们觉得局面在自己掌控中的时候。当没有人看着我们时，保持诚信和坚持是最难的。Many of us fail to see the other side of the equation, especially when we feel we are in charge of the situation. Being authentic and consistent is hardest when no one is watching us.
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