到岗时间:不限
年龄要求:不限
性别要求:不限
婚况要求:不限
岗位要求:
1、临床医学、临床药学、预防医学、药学、护理学等相关专业本科及以上学历;2、CET6,读写流利;3、有志于在临床试验行业发展,工作表现优秀有留用机会;4、此职位面向2019年毕业生,希望每周实习3天以上,持续半年以上。
Responsibilities
(1) MonitoringMonitoring- Perform pre-study visit to ensure the site has adequate resources for the study.- Ensure Principal Investigator/study staff complies with safety reporting requirements, as definedin protocol, SOP an d ICH-GCP.- Track study recruitment to ensure recruitment target is achieved in all studies.- Conduct monitoring visit according to SDV plan an d SOP; address issues with sites an d completemonitoring visit report in a timely manner Coordinating- Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site forstart-up an d throughout the study.- Assemble site specific EC submission dossier, an d ensure submission to EC.Training- Provide ongoing training to site staff with regards to ICH-GCP, study protocol an d requirements.- Conduct site initiation to ensure that the site has a thorough understanding of the study protocoland requirements.Documentation- Collect essential documents at study start-up, during an d at study close-down. Maintain andUpdate these documents in investigator files, trial master files.- Prepare/Pack for archiving at the end of the study.(2) Drug Safety- Ensure safety information is disseminated to all sites according SOP an d applicable regulations.- Report SAE promptly according to SOPs an d applicable regulations.(3) Finance an d Administration- Finalize budget an d obtain signed contract from site, prior to site initiation visit.- Ensure Study Payment Schedule is executed an d retain relevant documents/receipts.(4) Study Tools an d system- Update an d maintain Study tools/systems in a timely manner.
QualificationsBachelor degree in biomedical/science discipline Or equivalent (e.g. medical, Nurse , Pharmacology)Good understanding an d knowledge of Good Clinical Practice an d clinical trial operation processes/proceduresGood working an d proactive attitudeValue importance of teamworkGood command of written an d verbal English
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