临床研究专员II
Clinical Research Associate II
Precision for Medicine 不是典型的 CRO。我们热衷于培养我们的文化，并自豪地分享比行业平均水平高得多的 CRA 保留率。
CRA 加入我们后，会爱上他们的工作并留下来，因为这里有出色的人和愉快的生活质量。你将参与的试验数量低于平均水平，这使你能够成为试验专家。差旅合理，因此你的工作与生活平衡将得到改善。最重要的是——你的声音会被听到。在较小的 CRO 工作，让你在关键时刻拥有影响力和作用，并获得直接上级管理的支持。
Precision for Medicine 正在寻找位于马德里或巴塞罗那的 Clinical Research Associates II 加入我们的西班牙团队。
关于你：
- 当事情不如预期时，你保持冷静、深思熟虑且反应迅速。
- 无论是在研究者会议、现场访问还是项目团队更新中，你总是准备充分，始终比游戏提前两步。
- 你能够快速而创造性地克服困难。
- 你对细节有极高的敏锐度。
- 你能识别潜在的研究风险，并提出如何减轻这些风险的解决方案。
- 你对自己的工作质量和结果负责。
- 你擅长通过使用经过验证的解决策略来处理冲突。
我们将如何让你忙碌并支持你的成长：
你将监督并负责临床研究在研究现场的进展，确保临床研究按照方案、标准操作流程（SOP）、ICH-GCP 和所有适用的法规和标准进行、记录和报告。你将协调设置和监控研究所需的所有必要活动（例如：确定研究者；协助准备监管提交文件，进行研究前和启动访问等）。
资格要求：
最低要求：
- 4 年制大学学位或同等经验
- 在 CRO 或制药/生物科技行业担任 CRA 至少 2 年或以上，或具有同等经验及相关经验/展示出的能力
- 临床研究中的现场管理或同等经验
- 有肿瘤学监测经验
其他要求：
- 可以接受国内差旅，包括过夜停留，差旅量可能占到大约 50-60%
- 英语流利，对于非英语国家，需掌握所在国的当地语言
- 候选人必须居住在马德里或巴塞罗那
优先考虑：
- 研究生学历或更高
查看英文原文
Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.
We are passionate about cultivating our culture and are proud to share extremely high CRA retention rates compared to industry averages. CRAs join us, love their jobs, and stay because of the amazing people and enjoyable quality of life. You will have a lower than average number of protocols, setting you up to be a protocol expert. Travel is reasonable and your work/life balance will benefit as a result. Most meaningfully - your voice will be heard. Working in a smaller CRO allows you to have influence and impact when it matters most and support from direct line management.
We are now recruiting Clinical Research Associate II to join our team in the Netherlands. This is a remote based position with travel to sites for morning visits. We are looking for candidates based in the Netherlands with biopharma monitoring experience.
About you:
- You are calm, thoughtful, and responsive when things don’t go as planned.
- You are well-prepared, whether it be for an investigator meeting, site visit or project team update, always staying two steps ahead of the game.
- You find quick and creative ways of overcoming difficulties.
- You have an impeccable eye for detail.
- You identify potential study risks and propose solutions on how to mitigate them.
- You take responsibility in the quality and outcomes of your work.
- You are adept at handling conflict by using tried and true resolution strategies.
How we will keep you busy and support your growth:
You will monitor and own the progress of clinical studies at investigative sites and ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards. You will coordinate all necessary activities required to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.).
Qualifications:
Minimum Required:
- Life science degree and / or equivalent experience
- 2 years or more as a CRA in either a CRO or pharmaceutical/biotech industry or equivalent, relevant experience and/or demonstrated competencies. Site management or equivalent experience in clinical research.
- Availability for domestic travel including overnight stays, as required (international travel may be required for some senior level positions)
Other Required:
- Excellent communication and organizational skills are essential. A team player.
- Evidence of a client focused approach
- Availability for domestic travel including overnight stays, which may constitute up to approximately 50-60% travel commitment (international travel may be required for some senior level positions)
- Fluency in English, Dutch
- French will be a plus
- oncology monitoring experience will be a plus
Preferred:
- Study start up activities experience.
Please apply in English.
#LI-EK1 #LI-Remote
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