-
3-4年经验 -
本科 -
招1人 -
03-05 发布
- 带薪年假
- 五险一金
职位描述
Primary Function:1) Responsible for Quality control of clinical trials, including set up co-monitoring plan with project manager or designate personnel, conduct and report co-monitoring visit, follow-up issues identified during the co-monitoring visit.2) Assist project team on site selection / initiation / monitoring activities as CRA role when necessary.Responsibilities:Quality control:a) Work on co-monitoring plan for project during the start-up phases together with project manager.b) Conduct and report co-monitoring visit according to co-monitoring plan or flexible when necessary.c) Discuss the issues identified during the co-monitoring visit with project manager or CRA's line-manager.d) Assist the project manager or CRA's line manager with site/CRA selection.e) Follow-op issues identified during the co-monitoring visit, share the findings and recommended action plan if applicable.CRA role:a) Act as the main line of communication between the sponsor and the investigator.b) Verifying that all research staff, facilities and investigational products have adequate qualifications and resources and these remain adequate throughout.c) Responsible for the safety and proper conduct throughout the trial.d) Verifying that the investigator follows the approved protocol and all GCP procedures.e) Verifying that source data/documents and other trial records are accurate, complete, and maintained.f) Adverse events, concomitant medications, and inter current illnesses are reported in accordance with the protocol on the CRFs.Qualifications:1) Bachelor degree, or equivalent, in Medicine, Science or related discipline.2) 2+ year independent monitoring experience with Oncology or Phi study is preferred.3) Strong knowledge in ICH-GCP.4) Ability to review and evaluate clinical data.5) Computer literacy desirable.6) Professional use of the English language, both written and oral.7) Excellence oral and written communication skills. 职能类别： 临床研究员 临床协调员 关键字： 临床研究 质量控制
联系方式
上海浦东张江高科技园区金科路4560号金创大厦1号楼4楼
公司信息
ZAI Lab is a leading biotech company based in China focused on discovering and developing innovative medicines for unmet medical needs globally. The company is building a strong portfolio of therapeutic programs aimed at transforming patients’ lives. Zai Lab has a world class leadership team with deep experience at global pharmaceutical and biotech organizations. The team has a strong track record of success – successfully taken five novel drug candidates into clinical trials in China, pioneered new regulatory channels, secured regulatory approvals in record times, conducted multiple IND trials in the US, and brought the first China discovered drug into Global Phase III trials. Zai Lab is committed to build a globally leading drug research and development powerhouse with a culture of excellence and teamwork and a strong focus on fostering innovation and creativity. For more information, please visit www.zailaboratory.com.
