【临床监查员CRA招聘】

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TA Manager 招聘经理 · 上海康德弘翼临床研究有限公司

聊一聊

职位介绍: 工作职责: 1. The Clinical Research Associate (CRA) will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH‐GCP, and all applicable, Regulatory requirements. 2. 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 3. 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 4. Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely 5. Provides regular site status information to team members, trial management, and updates trial management tools 6. Completes monitoring activity documents as required by Company or Sponsor SOPs or other contractual obligations 7. Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues 8. Escalates site and trial related issues per Company SOPs, until identified issues are resolved or closed 9. Performs essential document site file reconciliation 10. Performs source document verification and query resolution 11. Assesses IP accountability, dispensation, and compliance at the investigative sites 12. Verifies Serious Adverse Event (SAE) reporting according to trial specifications and relevant local and ICH GCP guidelines 13. Communicates with investigative sites 14. Updates applicable tracking systems 15. Ensures all required training is completed and documented 16. Be assigned logistical support tasks by CTM for Investigator Meetings 任职资格: 1. 1 to 3years 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

其他信息: 语言要求：英语; 行业要求：全部行业

公司简介

康德弘翼（WuXi Clinical），是药明康德（WuXi AppTec）的一家全资子公司，始终致力为客户提供全方位的临床研究服务。我们为药品、生物制品和医疗器械等医药产品提供全方位的I至IV期临床研究服务。从I期临床研究到最终申报注册，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，公司人员规模达1000人，覆盖中国30个主要城市，在上海、北京、广州、武汉、成都、长沙、西安、沈阳和美国奥斯汀、圣地亚哥10个城市均设有办公室。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。随着业务能力的不断提升，我们已将业务范围成功扩展到美国、欧盟和亚太地区的部分国家。2018年7月，药明康德通过成功收购位于得克萨斯州的美国临床研究机构，让WuXi Clinical的规模再一次扩大，进一步完善和增强了我们一体化研发服务平台的综合实力，帮助全球创新合作伙伴更好、更快地开发医药产品。

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