更新于 5月14日

SSU 临床启动专员

1-1.8万·13薪
  • 北京朝阳区
  • 1-3年
  • 本科
  • 全职
  • 招1人

职位描述

CTACRC医药制造
职责描述: 1.根据试验方案、SOP、GCP 和合同规定的工作范围,负责研究中心 GCP/EC 文件准备、递交沟通工 作,并协助取得伦理批件; 2.负责研究中心临床试验协议的拟定、谈判与签署以及经费预算表制作等工作; 3.可同时负责多个项目、不同治疗领域内的研究中心启动工作; 4.及时向项目组反馈与研究中心沟通意见,并协助解决项目启动阶段发生的各种问题; 5.定期更新和维护公司内部系统数据库以及项目 tracker 信息; 6.根据申办方要求、临床试验方案及研究中心基本规定,合理制定项目计划、评估项目完成时间表; 7.负责协调研究中心启动所需必要文件的收集、审阅和批准等工作; 8.在规定的项目时间限内,管理记录并实时跟踪文件递交进度、伦理审评意见、合同谈判流程等; 9.定期向项目组汇报所负责研究中心的研究进度并制定后续工作计划; 10.与其他职能部门共同合作,或需直接与申办方沟通相关工作。 任职要求: 1.本科及以上学历,医药相关专业; 2. 了解相关临床研究知识和适用的法规要求; 3. 1 年以上临床经验,有 SSU/CRA/CRC 经验者优先考虑; 4.良好的学习能力和沟通能力,有效的时间管理和协调组织能力; 5. 英语读写熟练,可进行基本对话,通过 CET-6 者优先考虑

工作地点

朝阳区北京侨福芳草地购物中心

职位发布者

钟奕姣/HR

立即沟通
公司Logo爱恩康临床医学研究(北京)有限公司
At ICON we believe that our people are the most important asset. It is they who have helped to make ICON the success it is. Their commitment to clients, quality and delivery has earned ICON its enviable reputation. About DOCS: DOCS- ICON Resourcing Solutions is a division of ICON plc that provides global staffing solutions to Pharmaceutical, Biotechnology, Medical Device companies and CROs in over 39 countries. We can recruit in virtually any location having access to offices in over 25 countries. This truly makes DOCS a company with global reach and personal focus. ICON has been in APAC since 1996 and the DOCS division of ICON is now expanding in the APAC region. Our Services: We are a specialist recruitment division focusing in Clinical Research, Medical Affairs, Regulatory Affairs, Drug Safety, Health Economics, Data Management& Statistics, Quality Assurance etc. Our full-spectrum resourcing solutions extend from contingent staffing, to functional resourcing, large-scale FSP and executive search. In addition, DOCS has developed a tailored training division‘CRAcademy’ to provide Traineeships and Training. We can recruit in virtually any location having access to offices in over 25 countries. This truly makes DOCS a company with global reach and personal focus. Our History: DOCS was formed in The Netherlands in 1997 and grew to become the premier resourcing provider to the European pharmaceutical industry. The company was acquired by ICON plc in 2007 and was merged with ICON’s existing resourcing division, ICON Contracting Solutions. The merged company is now known as DOCS, and offers clients over 15 years of experience in the provision of global resourcing solutions. For more information, please visit www.docsglobal.com& www.iconplc.com.
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