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无工作经验 -
本科 -
招3人 -
12-22 发布
- 五险一金
- 交通补贴
- 餐饮补贴
- 年终奖金
职位描述
CRA Job SummaryCompletes project activities associated with monitoring functions of Phase I-IV clinical research studies while demonstrating mastery and a deep understanding of the drug development process, Good Clinical Practices (GCP), and relevant regulations. Performs management of study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs) and Project Specific Operating Procedures. May assume the role of a Lead CRA (LCRA) on projects by providing direction and guidance to project team, coordinating all monitoring activities, and communicating the status of these activities to the study Project Leader.RequirementsBA/BS or MS degree in science/health care field or nursing degree or equivalent combined education and experience. Extensive clinical monitoring experience. Demonstrates extensive understanding of SOPs, WI, FDA, and local regulations as well as ICH GCP guidelines and an advanced understanding and application of applicable therapeutic standards. Effective command of written and spoken local language as well as English. Ability to handle multiple tasks to meet deadlines in a dynamic environment. 职能类别: 临床研究员
联系方式
银霄路39弄33号
公司信息
铂镁医学临床研究(上海)有限公司注册于上海张江高科技产业园区,是一家为国内外医药界提供新药或仿制药临床开发(Ⅰ-Ⅳ期)和药剂工艺改良的全方位外包服务公司。
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