上海 [切换城市] 上海招聘上海生物/制药/医疗器械招聘上海临床协调员招聘

Clinical Trial Assistant 临床试验助理

复星凯特生物科技有限公司

  • 公司规模:150-500人
  • 公司性质:合资
  • 公司行业:制药/生物工程

职位信息

  • 发布日期:2020-11-22
  • 工作地点:上海-浦东新区
  • 招聘人数:1人
  • 工作经验:1年经验
  • 学历要求:本科
  • 职位月薪:10-15万/年
  • 职位类别:临床协调员  临床数据分析员

职位描述

Key Accountabilities:
1. Support the whole project process and file all project documents as required.
2. Provide admin support to the study team.
3. Support to print Ethics / Regulatory packages for CRAs and track all documents submissions & approvals.
4. Set up and maintain Trial Master Files (TMF) and Investigator Site File (ISF-central level).
5. Support CRA to prepare Investigator Site Files (ISF-site level).
6. Support CRA to submit and track study SUSAR/SAEs and other essential documents to sites.
7. Support study contract sign-off and payment process, track payments and invoices collection.
8. Maintain study status tracking logs and documents of TMF/ISF-central level, including study timeline, site selection and initiation status, subject recruitment, site and vendor contract & payment, EC submission records, drug & supplies shipping and return, CRA monitoring visit, CRA handover, etc.
9. Support PMs to prepare the investigator meeting and other study routine meeting on logistic part.

Support functional team on other things as needed.

Qualifications:

1. Bachelor’s Degree, biology or medicine is preferred
2. Excellent organizational skills and ability to prioritize and multi task
3. Fluent in English

公司介绍

关于复星凯特生物科技有限公司
复星凯特生物科技有限公司为上海复星医药集团与美国 Kite Pharma(吉利德旗下公司)的合营企业, 2017年 4月于中国上海注册成立。立足于自主研发和技术转移相结合,复星凯特致力于肿瘤免疫细胞治疗技的产业化和规范化,造福中国患者。

About Fosun Kite Biotechnology Co., Ltd.
As a joint venture of Shanghai Fosun Pharmaceutical (Group) Co., Ltd and U.S. Kite Pharma, Fosun Kite Biotechnology Co., Ltd. (hereinafter referred as "Fosun Kite") was established in April 2017 in Shanghai China. Taking a combined approach of internal R&D and external partnering/technology transfer, Fosun Kite is dedicated to the advancement of innovative cell therapy and its industrialization in China to benefit patients.

联系方式

  • 公司地址:周浦