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临床监查员CRA


Responsibilities

一、     Site management 中心管理

1.    Study site selection, initiation(SIV) and clinical monitoring

2.    Provide ongoing training to site staff with regards to GCP, study protocol and requirements, Conduct site initiation to ensure that the site has a thorough understanding of the study protocol

3.    Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files, Prepare/complete study records’ archiving according to protocol and sponsor requirements.

二、     Drug Safety 药品安全

1.    Ensure safety information is disseminated to all sites according SOP and applicable regulations.

2.    Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations.

三、     Finance and Administration 财务管理

1.    Finalize budget and obtain signed contract from site, prior to site initiation visit.

2.    Ensure Study Payment Schedule is executed and retain relevant documents/receipts.

四、     Study Tools and system 研究工具和系统

       Update and maintain Study tools/systems in a timely manner.

 

Qualifications

(a) Academic / Major 学历 /专业

Bachelor degree in biomedical/science discipline or equivalent (e.g. medical, Nurse , Pharmacology)

(b) Professional Skills 专业技能要求

Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures

Good working and proactive attitude

Value importance of teamwork

(c) Working Experience 工作经验要求

At least half year (for CRA with master degree or above) or one year of CRA experiences

 (d) Language ability 语言能力

Good command of written and verbal English

 (e) Computer Literacy 电脑相关知识

Good skills on Microsoft Word, Excel, PPT and Outlook, etc


如您有应聘意向,请将您的中英文简历发给我们,并在邮件中注明期望工作地点以及应聘的岗位名称

杭州(总部)
地址:杭州市滨江区江南大道618号东冠大厦15层
邮编:310053
电话:0571-28887227-8171
Email:HR@tigermed.net