更新于 12月27日

临床监查员CRAII

1.4万-1.6万
  • 上海黄浦区
  • 1-3年
  • 本科
  • 全职
  • 招999人

职位描述

Ⅱ期Ⅲ期Ⅰ期药品临床监查GCP认证
岗位职责:
•Implements and monitors local clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH‐GCP guidelines
•Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites
•Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely
•Provides regular site status information to team members, trial management, and updates trial management tool.
•Completes monitoring activity documents as required by Company or Sponsor SOPs or other contractual obligations
•Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues
•Escalates site and trial related issues per Company SOPs, until identified issues are resolved or closed
•Performs essential document site file reconciliation
•Performs source document verification and query resolution
•Assesses IP accountability, dispensation, and compliance at the investigative sites
•Verifies Serious Adverse Event (SAE) reporting according to trial specifications and relevant local and ICH GCP guidelines
•Communicates with investigative sites
•Updates applicable tracking systems
•Ensures all required training is completed and documented
•Be assigned logistical support tasks by CTM for Investigator Meetings
任职要求:
1. About 2 years of local trial experience; exposure to MNC and global or Local Phase I -IV trials Clinical research experience
2. Knowledge of ICH and local regulatory authority regulations regarding drug
3. An advanced degree (e.g., M.S., M.B.A., Phar.D., etc.)

工作地点

Soho复兴广场

职位发布者

顾意蓉/高级人力资源专员

三日内活跃
立即沟通
公司Logo上海康德弘翼医学临床研究有限公司
康德弘翼(WuXi Clinical),是药明康德(WuXi AppTec)的一家全资子公司。始终致力为全球客户提供全方位的临床研究服务,包括药品、生物制品、医疗器械、体外诊断试剂等医药产品,涵盖BE(Bioequivalence)/ I期至IV期的临床试验。通过严格的质量控制体系和专业团队的丰富经验,帮助创新性,突破性医药产品尽快上市和造福患者。康德弘翼立足中国,面向世界,以上海总部为中心,辐射全球制药公司、生物技术公司以及医疗器械公司。目前,公司实行全球联合运营,人员规模达850+人,运营能力覆盖中国、美国及澳大利亚等,并在上海、北京、广州、武汉、成都、长沙、西安、沈阳、中国台北、美国奥斯汀、美国圣地亚哥和澳大利亚悉尼等地均设有办公室。公司团队与各研究中心建立了良好的合作关系,始终保持着紧密的业务交流,保证了项目能高效、高质地完成。随着业务能力和业务范围的不断拓展,康德弘翼进一步完善和增强了全球一体化研发服务平台的综合实力,助力全球创新合作伙伴更好、更快地开发医药产品。
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