职位描述
职位描述: 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 and ICH-GCP.- Track study recruitment to ensure recruitment target is achieved in all studies.- Conduct monitoring visit according to SDV plan and SOP; address issues with sites and completemonitoring visit report in a timely manner Coordinating- Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site forstart-up and throughout the study.- Assemble site specific EC submission dossier, and ensure submission to EC.Training- Provide ongoing training to site staff with regards to ICH-GCP, study protocol and 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 and 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 and applicable regulations.- Report SAE promptly according to SOPs and applicable regulations.(3) Finance and Administration- Finalize budget and obtain signed contract from site, prior to site initiation visit.- Ensure Study Payment Schedule is executed and retain relevant documents/receipts.(4) Study Tools and system- Update and maintain Study tools/systems in a timely manner.QualificationsBachelor degree in biomedical/science discipline or equivalent (e.g. medical, Nurse , Pharmacology)Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/proceduresGood working and proactive attitudeValue importance of teamworkGood command of written and verbal English 职能类别: 临床研究员 实习生
公司信息
杭州泰格医药科技股份有限公司(股票代码:300347),是一家专注于为医药产品研发提供临床试验全过程专业服务的合同研究组织(CRO)。致力为客户降低研发风险、节约研发经费,推进产品市场化进程。
公司总部位于杭州,下设33子公司,在中国大陆53个主要城市和中国香港、中国台湾、加拿大、美国、韩国、日本、澳大利亚、马来西亚、新加坡、印度等地设有服务网点,拥有近2000多人的国际化专业团队,为全球600多家客户成功提供了500余项临床试验服务。泰格医药更因参与57余种国内创新药临床试验,而被誉为 “创新型CRO”。
泰格能为您做什么?
我们将为您提供:有针对性的职业发展计划;
系统的岗位培训(SOP培训,GCP培训,在岗培训及各种技能培训);
完善的福利(缴纳五险一金及商业医疗保险,带薪年休假,各种假日福利);
与公司共同发展的职业平台。
战略目标
成为全球最有影响力的CRO公司之一。
核心业务
提供以临床试验为主的医药产品研发专业服务和解决方案。
公司使命
提高医药产品研发效率和效益,促进人类健康事业发展。
核心价值观
正直诚信、实事求是、敬业合作。
经营理念
坚持以人为本,尊重每位员工的价值,关注员工的职业成长与发展。
以质量求生存,以科学、严谨、求是的专业态度,提供规范、优质、高效的临床研究相关服务。
不断提升公司专业价值,珍惜每一次合作机会,努力为客户提供增值的用户体验。
如有应聘意向,请将您的中英文简历发给我们。
我们的邮件地址:hr@tigermed.net