长沙招聘

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. 2 to 4 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.)

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。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，公司实行中美联合运营，人员规模达850人，覆盖中美两地，全国30多个主要城市，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，药明康德成功收购位于德克萨斯州的一家美国临床研究机构并实现中美联合运营，2019年5月，再一次收购了位于圣地亚哥的临床研究服务公司Pharmapace，这让WuXi Clinical的规模再一次得到扩大，进一步完善和增强了我们全球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。