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.
(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