北京招聘

1)    Responsible for quality control of clinical trials, including conduct and report co-monitoring visit, identify and address project specific issues and general monitoring issues, and follow-up issues identified during the co-monitoring visit.
2)    Monitor the CRA’s performance at the site and coach CRA if necessary.

1)    Conduct co-monitoring visit according to co-monitoring plan as on-the-job coaching activity and quality control activity for the projects.
2)    Monitor the CRA’s performance at the site.
3)    Identify and address any project specific issues according to the protocol, monitoring plan and other study specific requirements.
4)    Discuss the issues identified during the co-monitoring visit with CRA, project manager and CRA’s line manager.
5)    Follow-up issues identified during the co-monitoring visit until issues close, share the findings and recommended action plan if applicable.
6)    Provide support for audit, inspection or other quality related activities.
职位要求：
1)    Bachelor’s degree, or equivalent, in Medicine, Science or related discipline.
2)    3+ year independent monitoring experience, phase III oncology trial experience 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)    Excellent oral and written communication skills.

Zai Lab is an innovative biopharmaceutical company based in Zhang Jiang, Shanghai focused on bringing transformative medicines for cancer, autoimmune and infectious diseases to patients in China and around the world. Zai Lab focus on innovation to meets the unmet medical needs. Zai has built up a strong pipeline with multiple programs on clinical stages. Zai Lab successfully listed on Nasdaq in Sep. 2017.

再鼎医药是一家总部设立于上海张江，致力于研究、开发和销售创新药物的制药企业。再鼎医药针对目前尚无良好治疗手段的疾病领域开发新药，在肿瘤、抗感染、自身免疫等方面建立了全面的产品线，服务中国和全球病患。再鼎医药于2017年9月在美国纳斯达克成功上市。