CRA/SCRA

该职位来源于猎聘 岗位职责 1、负责临床试验中心的筛选、启动、常规监查及关闭访视；严格按照试验方案、GCP及公司SOP进行监查，确保试验合规进行。 2、执行原始数据核查（SDV），审阅病例报告表（CRF/eCRF），确保临床数据的真实性、准确性、完整性和及时性。 3、跟踪并核查不良事件（AE）和严重不良事件（SAE）的记录与报告，保障受试者的权益与安全。 4、监控中心受试者入组进度，协助研究者解决招募障碍，确保按时完成入组目标。 5、维护研究中心文件夹（ISF）及试验主文件（TMF）；负责试验用药品的交接、存储、回收及记录管理。 6、负责申办方的II、III期项目全流程监查，定期向项目经理汇报中心进展，及时发现并解决试验中的问题。 任职要求 1、统招本科及以上学历，临床医学、药学或相关专业。 2、具备1.5年及以上大临床项目全流程监查经验（有肿瘤或特定治疗领域经验者优先）。 3、熟悉《药物临床试验质量管理规范》（GCP）、ICH指导原则及相关法规；熟练掌握临床试验流程。 4、具备良好的中英文读写能力，能熟练阅读英文医学文献及撰写英文监查报告。 Responsibilities

• Conduct site selection, initiation, routine monitoring, and close-out visits. Ensure trial compliance strictly according to the protocol, ICH-GCP guidelines, and company SOPs.
• Perform Source Data Verification (SDV) and review Case Report Forms (CRF/eCRF) to ensure the accuracy, completeness, and timeliness of clinical data.
• Monitor and verify the documentation and reporting of Adverse Events (AE) and Serious Adverse Events (SAE) to protect subjects' rights and safety.
• Track subject enrollment progress at sites, assist investigators in resolving recruitment barriers, and ensure enrollment targets are met on schedule.
• Maintain the Investigator Site File (ISF) and Trial Master File (TMF). Manage the receipt, storage, dispensing, and return of Investigational Products (IP).
• Serve as the primary point of contact between the sponsor and research sites. Report site progress to the Project Manager regularly, and promptly identify and resolve issues during the trial. Requirements
• Bachelor’s degree or above in Clinical Medicine, Pharmacy, or related scientific fields.
• At least 1.5years of direct clinical trial monitoring experience (experience in oncology or specific therapeutic areas is highly preferred).
• Solid understanding of China GCP, ICH guidelines, and relevant regulatory requirements; proficient in clinical trial processes.
• Fluent in both written and spoken English and Mandarin; capable of reading medical literature and writing monitoring reports in English.