长沙招聘

职位概要： 在临床项目启动阶段承担项目启动工作。能够相对独立进行所负责方案和研究中心的筛选、伦理递交、合同谈判及核心文件准备工作。确保临床研究根据试验方案、标准操作规程（SOP）、药物临床试验质量管理规范（GCP）和适用的法律法规进行。

岗位职责：

1. 根据试验方案、合同规定的工作范围、SOP和GCP的要求进行研究中心筛选、伦理递交、合同 谈判和核心文件准备等工作。

2. 可同时负责多个项目、研究中心和治疗领域内的研究中心启动工作。

3. 对所负责的研究中心进行方案和研究相关的沟通，为项目筛选合适的研究中心。

4. 负责研究中心临床试验协议的谈判与签署工作。

5. 负责协调研究中心启动所需核心文件的收集、审阅、批准等工作。

6. 负责研究中心伦理文件准备、递交、沟通等工作，并协助取得伦理批件。

7. 协助研究中心启动前药品及试验物资的准备及分发工作。

8. 通过追踪注册申报和批复、递交及批准文件的沟通信、电话沟通等，管理所负责研究中心的 进展。

9. 负责相应研究中心启动阶段的研究财务管理。

10. 协助进行项目的可行性调研。

任职资格：

1.本科以上学历，医学、护理学等相关专业；

2.医学专业知识丰富；

3.熟练操作Windows系统，熟练使用MS Word，Excel，PPT，熟悉 Internet；

4.2年及以上SSU工作经验,熟悉ICH GCP；

5.良好的人际沟通和组织协调能力；

6.较强的独立工作能力,具有团队合作精神；

  Beijing Health Tech Medical Group (HT-Med) was founded since 2004. We are a comprehensive medical Operation and development organization .Assemble excellent talents of medicine, pharmacy, data management and statistical fields, offering professional services to support biotech and pharmaceutical companies at every stage of product lifecycle .
 
 We provide Medical translation, Data Management, Statistical Analysis, Medical Writing, Regulatory Affairs, Project Evaluation and Management, Independent Audit, Training, CRA/CRC/DM dispatch. Since we established, we were developing new drugs with Chinese Academy of Medical Sciences, Peking University Health Science Center, The General Hospital of the PLA, Military Medical Sciences, etc. Has cooperated with over 90% clinical trial sites (hospital) approved by SFDA.

  We developed independently EDC+CTMS by ourselves, obtained 3 patents and 2 brands. Basing on excellent IT capability, we develop Products Data Center for our clients, and created role exchange pattern between CRA and CRC, improved speed&quality of Clinical Study by the model of EDC+CRC, especially in PMS. We have been became the vendor of lots of global company (AZ, GSK, BI, Abbott, Roch, Mundipharma, QPS etc.) and some official Institution (Chinese Academy of Medical Sciences, Peking university, The general hospital of Chinese PLA, Sanming hospital, Zhejiang oncology hospital, Academy of Military Medical Sciences of the Chinese PLA etc.).

 We are familiar with China SFDA policy and CDE mentality, possessing mass of expert resource and marketing support. we could cover 90% Chinese certificated clinical research hospital by lots of home-based employee in 18 cities.

  公司邮箱：yanmei.wang@ht-med.com
  公司网址：http://www.ht-med.com