长沙招聘

岗位职责：

1.作为研究团队成员，遵照法规要求、商定的工作范围、适用的SOP、工作授权和试验方案，在研究中心进行工作，协助研究者完成可行性调查问卷和回收问卷；

2.推动研究中心启动工作：协助研究中心筛选访视，协助及时提交文件到伦理委员会进行审批和试验用药品的发放，协助研究中心启动访视；

3.协助研究者进行受试者筛选和入组研究。得到研究者授权后，根据法规和GCP的要求，协助研究者顺利完成方案要求的随访和步骤：如制定计划、清点核对药品和其他协调工作；

4.在研究中心协助研究者管理试验用药品、研究物资和实验室样本；

5.在商定的工作范围内，参加研究者会、监查访视、稽查和其他会议；

6.协助研究者归档研究资料，并提交至伦理委员会或其他权威机构；

7.准确地将原始文件中的数据填写到病例报告表，并协助query的解答；

8.推动研究中心关闭：协助研究中心关闭访视、试验用药品和研究资料的回收，以及研 究资料的归档；

9.创建和维护日常工作报告和其他工作文件；

任职要求：

1.知道临床研发和法规要求的相关知识；

2.有BE项目1年以上经验；

3.熟悉医学术语；

4.较高的人际沟通及组织能力；

5.熟练的中文说写能力。要求基本的英语水平；

6.大专以上学历，临床医学、药理学、护理、卫生保健或其他医学相关专业；

  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