臨床研究的職業發展是結構化的。自始至終，你都需要保持上進和激情——樂於學習會讓你迅速成長。我們來看看入門級CRA在晉升時提出的一些關鍵問題。
Clinical research offers a structured career progression. Throughout, you will need to remain motivated and passionate – a willingness to learn and travel will enable you to advance swiftly. We look at some of the key questions entry level CRAs ask when it comes to moving up the ranks.
Q1要成為CRA2，我需要做些什麼？
A1：作為CRA1，你需要工作1-3年，才能獲得晉升所需的經驗和知識。在這幾年裡，你需要學會以下知識和技能：
As a CRA I, you can expect to work anywhere between 1-3 years before you gain the typical level of experience and knowledge required to progress. During these years, you will need to have acquired the following knowledge and abilities:
如果你覺得這些很熟悉，那麼你已經在成為CRA2的道路上了：If these sound familiar to you, you will be on your way to becoming a CRA II:
獨立檢查病例報告表格 Reviewing case report forms (CRFs) without assistance了解關於嚴重不良事件（SAE）報告的知識，以及如何根據規定繼續推進和隨訪Knowledge of serious adverse events (SAE) reporting and how to proceed and follow up within defined frameworks理解知情同意書（ICF）的內容Understanding the components of informed consent forms (ICFs)中心及試驗監查和管理經驗Demonstrable site and trial monitoring and management experience啟動臨床試驗中心文件的準備和收集Enabling the preparation and collection of clinical trial site documentation組織和執行中心關閉任務Organising and executing site closeout tasks
Q2我能成長得更快嗎？
A2：如果你渴望快速成長，請充分利用所有的培訓和發展機會。很多CRO公司有在線門戶網站，你可以通過這些網站獲得豐富的知識、參加培訓和測驗。培訓課程可以提供一些必要的技能，幫助你成功晉升到更高的職級，然而，成為CRA並不是一場賽跑。在準備成為CRA2之前，你需要掌握的主要能力，是你每天都會用到的技能和知識。
If you are keen to develop quickly, make sure that you take full advantage of all the training and development opportunities available. Many CROs have online portals where you can access a wealth of extra knowledge, training programmes and tests. Training courses are designed to provide the necessary skills to succeed at a more senior level; however, becoming a CRA is not a race. The skills and knowledge you demonstrate on a daily basis are the main competencies you will need to master before considering becoming a CRA II!
Q3我成為SCRA後要做什麼？
A3：隨著你的角色變更，日常工作職責也會增加。你將更多地負責臨床試驗的準備和關閉。你需要確保所負責的中心效率保持在較高的水平，你可能還要管理一個小型的CRA團隊。一對一的指導對多數CRO公司來說很重要，所以你必須準備好幫助那些在你曾經的位置上的人！
Your day-to-day responsibilities will increase to reflect your new role. You will become more accountable for preparing and closing clinical trials. You』ll be ensuring that the performance of assigned sites will remain high and you may also be tasked with managing a small team of CRAs. Peer-to-peer mentorship is important to many CROs so you must be prepared to assist people who were once in your shoes!
Q4我怎樣才能知道自己是否可以成為SCRA了？
A4：作為CRA1，你是否對這個角色的每個方面都很滿意？誠實地給自己對於SCRA崗位職責的匹配度做個評價。或許可以問問你的經理你個人的成長情況，以及他/她是否認為你已經充分做好了晉升的準備。根據你與經理共事的時間長短，他們會對你目前的經驗水平和是否能成為SCRA有所判斷。
Are you comfortable with every aspect of your role as a CRA I? Be honest with yourself about how well you fit the advertised SCRA job specification. It may be worth asking your manager about your personal progression and how ready he/she thinks you are. Depending on the length of time you』ve worked with your manager, they will have an understanding about your current level of experience and SCRA suitability.
就像我們之前說的，成為SCRA不是一場賽跑。你的前進路徑是獨一無二的——有些試驗往往更複雜，要求CRA有更多（或更垂直）的經驗。對於一個人多久能夠成為SCRA，並沒有一個特定的參考時間——我們建議你利用所有可利用的培訓機會，並在你每天的工作中都認真努力。
As we said before, becoming a SCRA is not a race. Your progression curve is unique – some trials are often more complex and require CRAs with more extensive (or niche) experience. There is no set guideline to when someone is 『ready』 to become a SCRA – we recommend you take advantage of any available training opportunities and continue to work hard in your day-to-day role.
Jesse，某知名外資CRO公司PM
擁有3年藥物臨床試驗項目管理經驗