[北京]上海百利佳生医药科技有限公司

公司官网:ww***com[点击查看] 专业1:临床医学与医学技术 专业2:药学 职能类别:临床研究员

Responsibilities:

• 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.

  Qualifications:

  A 4-year BS (Bachelor of Science) degree or equivalence experience. Advanced degree is a plus.

  Good command of written and spoken in English or other second language.

  Good organization and communication skills.

  High attention to detail and accuracy.

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（PPC Group）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，PPC佳生已经完成了超过2000项早期临床试验项目，其中包括创新药I期研究、仿制药生物等效性研究以及生物类似药早期临床研究（包含新药I期PK、仿制药BA/BE以及生物类似药PK/PD）。同时，PPC佳生也已经完成超过400项II期至IV期临床试验项目，其中涉及24个主要研究领域。目前PPC佳生是亚太区域唯一通过中国台湾TFDA,日本PMDA,法国ANSM，东盟NPRA，美国FDA以及中国CFDA核查的临床基地。   2012年，PPC佳生于台北（MacKay Memorial Hospital）建立了第一家下属I期临床研究中心；2017年初作为主要投资方与徐州医科大学合作共同建立了徐州医科大学附属医院I期临床研究中心；2018年，PPC佳生又分别与徐州市中心医院，鄂东医疗集团黄石市中心医院以及上海市浦东新区人民医院共同建立并开设了三家专属的I期临床研究中心。 工作时间：周一到周五9:00-18:00（弹性工时） 年假：第一年15天，每加一年加1天，20天封顶 带薪病假：5天 五险一金：按基本工资作为基数，足额缴纳 试用期工资：100%发放，与转正一样