The Importance of Clinical Research Associate Training to Support Effective Trials
临床试验景观目睹了III期试验的增加，平均超过3,500名患者。随着这些大型试验的更多，许多合同研究组织（CROS）和赞助商正在努力招聘
合格的临床研究伙伴（CRAs）支持工作涌入。
缺乏经验丰富的人才是市场面临的主要挑战之一，影响提案国和CROS相同的成本和扩展时间表。然而，迫切需要合格的CRAS将继续下去，从2012年预计该领域的需求将增长36.4％至2022年[1]in the US, an issue also reflected worldwide.
检查招聘障碍
临床试验行业敏锐地意识到压力。要及时了解这种紧急情况，如临床研究专业人员（ACRP）定位纸的协会所指出的，一种发展CRA劳动力的新方法，该行业需要评估当前的标准操作程序（SOP），并检查阻碍填充职位的障碍。
在景, we followed this guidance and brought together our leaders to holistically assess the market and our current investments. We found the industry truly lacked a harmonized global training program to develop CRAs—early in their careers—creating a major hurdle for job seekers. Furthermore, many scam training programs offer dubious certifications to CRA candidates interested in building skills within the field.
Proactively Growing the Clinical Research Associate Talent Pool
Recognizing this gap in training, we developed a global program to attract and retain talented people: the Covance Monitoring Excellence Academy (MEA). We wanted to give candidates from around the world the opportunity to grow into the CRA role, which ultimately enriches our lifeblood for the good of patients and transforms how we manage clinical trials.
The academy is more than a simple training program. MEA establishes an accelerated path through tailored scientific courses, interactive modules, hands-on experience and an ongoing mentoring program. Trainees receive a solid foundation that lays the groundwork for a rewarding career path.
建立成功的途径
Covance Mongeard Excellence Academy设计有两个途径，可以租用员工并以标准的全球时尚培训。第一条路径侧重于我们称之为CRA“助理角色”。这些候选人具有相关的教育，但在临床研究环境中的经验有限。通过经验丰富的团队成员的指导，他们可以在内部角色工作，并学习作为CRA的所有方面，为最近寻找快速跟踪的职业道路作为CRA的毕业生创造了完美的机会。
行业经验丰富的员工，如研究护士，网站学习协调员或临床研究协调员是第二条路径的理想选择。在这里，MEA课程教他们如何在临床试验中有效地管理作为CRA的临床试验。在许多情况下，这些员工是远程员工，在MEA计划中从家庭办公室工作。
无论途径如何，我们发现训练有素的工作人员觉得能够带来更加一致的方法，以便他们如何监控和管理网站，加强我们的质量，准确性和卓越的驱动。并且，临床研究助理团队，具有不同经验水平的不同背景，提供更具创新性，整体和独特的视角，使用“批判性”来明智地管理我们的试验 - 对每个人的真实价值。
灵活的课程，专注于增长
The MEA program offers tailored tracks based on a candidate’s individual level of industry knowledge and experience. Over a three- to six-month period, participants advance their clinical operation competencies through a comprehensive blended face-to-face and web-based curriculum:
| Regional Training Modules | Allows candidates to participate in training modules based on experience in the industry―ranging from team roles and responsibilities to clinical trial design to remote monitoring |
| Clinical Foundations | 概述临床试验的活动，流程和组成部分，强调赞助商，地点，道德委员会和CRA的角色和责任 |
| 同伴支持和观察培训 | Offers participants the opportunity to partner with and observe skilled CRAs to further develop competencies, expand critical thinking skills and gain co-monitoring experience |
| Regional Case Studies, as applicable | 通过基于场景的培训案例研究，从纠正和预防措施（CAPAS）和临床质量控制（CQC）访问调查结果中创建的基于场景的培训案例研究 |
监测卓越学院的船上时间表
支持员工，客户和审判
通过MEA计划，毕业生获得全面的真实体验，并彻底了解GCP和ICH监管要求，同时在熟练和培训的CRAS支持网络中工作。
Participants work with a regional point person that provides real-time support when questions arise and ensures the individuals understand all aspects of the clinical trial monitoring through the MEA program period and beyond—before accepting any individual assignments. This process ensures the highest data quality for more successful site performance.
提供第一行防线
“在任何临床试验中，数据完整性和患者安全都是我们的首要任务，”全球第二阶段第四级，临床发展副总裁兼总经理博士·戴维博士说。“作为知识渊博的专业研究专业人士，了解监测科学及其协作性质，CRAS代表第一道防线。这就是为什么我们在密卡努力努力通过卓越的监测学院投资人才。“
具有深入的经验，在整个开发谱中的质量和治疗区域专业知识的声誉 - 来自非临界通过第四阶段和安全监测 - 概念熟练的CRA在成功试验中的基本作用。“客户可以希望与临床研究中持续持续到持续的质量的创新个人合作，”戴维说。“同样，CRAS可以指望我们从他们走在门口的那一刻，我们会奖励他们的努力。”
As a partner in this collaborative, talent-building process, we continue to hear from our clients how satisfied they are with the MEA coursework and the knowledge-base of their new enthusiastic Clinical Research Associates. If you’d like to learn more about Covance’s extensive clinical solutions or the Monitoring Excellence Academy opportunity, please visit ourCovance CRA职业网站。
[1]劳工统计局
