更新于 4月13日
职位描述
药品临床监查GCP认证Ⅲ期Ⅳ期Ⅰ期Ⅱ期普药肿瘤药
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 3 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.)
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 3 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.)
职位福利：五险一金、绩效奖金、年底双薪、弹性工作、节日福利、周末双休
工作地点
广州越秀区中华国际中心-A塔24层2403房
公司信息
上海康德弘翼医学临床研究有限公司
不需要融资 · 500-999人 · 医药制造、医疗设备/器械、卫生服务、学术/科研
已审核
公司介绍
康德弘翼（WuXi Clinical），专注于为全球客户提供覆盖药物全生命周期的临床研究解决方案。聚焦肿瘤与自身免疫性疾病等核心领域，以专业深度驱动临床策略落地，助力差异化产品快速推进。服务覆盖I至IV期临床，结合专家团队与智能管理平台，助力创新疗法高效上市，为全球患者带来更佳治疗选择。