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[上海]上海百利佳生医药科技有限公司
职位：临床监察员
发布时间：2018-02-05
工作地点：上海
信息来源：前程无忧(51JOB)
职位类型：全职
职位描述
公司官网:ww***com[点击查看] 专业1:基础医学 专业2:药学 职能类别:临床研究员
Contribute comments/input in the development of Protocol, Informed Consent Form (ICF), Case Report Forms (CRF) and other project related documents.
Evaluation potential sites with the assistance from the senior CRA, PM or line manager and provide PM with recommendations for selection of qualified sites.
Prepare the package for institutional review boards (IRB) and local regulatory authority submissions and obtain IRB/regulatory approvals for conducting the clinical trial.
Assist PM in start-up meeting.
Prepare and manage the clinical trial agreements with investigators/sites.
Track, manage and control the site budget and expenses within approved budget and in line with the project milestones as requested.
Manage/coordinate the investigational products and clinical trial materials for the sites in compliance with regulatory requirements.
Monitor and report the project status at the sites in a timely manner.
Key contact person for the communication between the sites and study team.
Prepare, arrange and conduct the training of site personnel.
Conduct site initiation, monitoring and site close-out visits in compliance with monitoring plan, ICH-GCP, SOPs, local regulations and other applicable project-specific plans.
Prepare monitoring report according to the SOP.
Assist the investigator for auditing/inspection of project.
Coordinate with the sites to ensure all adverse events and follow-up are appropriately reported and reconciled according to regulations.
Identify, analyze and resolve the issues at the investigator sites.
公司简要介绍：
公司名称:上海百利佳生医药科技有限公司
公司类型:外资（欧美）
公司规模:150-500人
公司介绍:PPC佳生（Protech PharmaservicesCorporation）成立于1997年，致力于为国内外制药企业及生物技术公司提供专业化临床研究服务，为中国大陆、中国台湾、韩国以及日本等亚太地区客户提供临床试验及生物样本检测分析服务。自1997年至今，自成立以来，PPC佳生已为来自全球范围客户完成了2000多个早期临床研究项目（包含新药I期PK、仿制药BA/BE以及生物类似药PK/PD）；并且还执行了超过400个新药后期临床试验项目；所执行的研究方案涵盖24个疾病治疗领域。目前是亚太区域唯一通过日本PMDA、欧盟ANSM、东盟NCPB以及美国FDA核查的临床基地，生物样品实验室开发约300种药品分析方法，以丰富的执行经验提供海内外客户优质服务。2012年，PPC佳生于台北（McKay memorial Hospital）建立了第一家下属I期临床试验中心，并于2016年作为主要投资方与徐州医科大学资源共享，优势互补联合组建合作共同建立了徐州医科大学附属医院I期药物临床试验中心。