临床监查员(CRA) 面议 收藏 投递简历
您当前的位置: 医药人才网 > 职位列表 > 临床监查员(CRA)

临床监查员(CRA)

面议
吉林-长春 | 1-3年经验 | 本科学历
朝九晚五 交通方便 加班补助 节日福利 周末双休 员工旅游
职位描述
到岗时间:不限 性别要求:不限性别 婚况要求:不限婚况

Responsible for all aspects of study site monitoring including routinemonitoring and close-out of clinical sites, maintenance of study files,conduct of pre-study and initiation visits; liaise with vendors; andother duties, as assigned. 
• Responsible for all aspects of site management as prescribed in theproject plans 
• General On-Site Monitoring Responsibilities: 
• Ensure the study staff who will conduct the protocol have received theproper materials and instructions to safely enter patients into thestudy 
• Ensure the protection of study patients by verifying that informedconsent procedures and protocol requirements are adhered to according tothe applicable regulatory requirements 
• Ensure the integrity of the data submitted on Case Report Forms (CRFs)or other data collection tools by careful source document review.Monitor data for missing or implausible data 
• Ensure the resources of the Sponsor and Covance are spent wisely byperforming the required monitoring tasks in an efficient manner,according to SOPs and established guidelines, including managing travelexpenses in an economical fashion according to Covance travel policy 
• Prepare accurate and timely trip reports 
• Manage small projects under direction of a Project Manager/Director asassigned 
• Serve as lead monitor for a protocol or project and may assist inestablishing monitoring plans as assigned 
• Review progress of projects and initiate appropriate actions toachieve target objectives 
• Organize and make presentations at Investigator Meetings 
• Report, write narratives and follow-up on serious adverse experiences 
• Participate in the development of protocols and Case Report Forms asassigned 
• Participate in writing clinical trial reports as assigned 
• Interact with internal work groups to evaluate needs, resources andtimelines 
• Act as contact for clinical trial supplies and other suppliers(vendors) as assigned 
• Responsible for all aspects of registry management as prescribed inthe project plans 
• Undertake feasibility work when requested 
• Recruitment of potential investigators, preparation of EC submissions,notifications to regulatory authorities, translation of study-relateddocumentation, organization of meetings and other tasks as instructed bysupervisor as assigned 
• Negotiate study budgets with potential investigators and assist theCovance legal department with statements of agreements as assigned 
• Complete process of Serious Adverse Event (SAE) reporting, processproduction of reports, narratives and follow up of SAEs 
• Independently perform CRF review; query generation and resolutionagainst established data review guidelines on Covance or client datamanagement systems as assigned by management 
• Assist with training, mentoring and development of new employees, e.g.co-monitoring 
• Co-ordinate designated clinical projects as a Local ProjectCoordinator (with supervision, if applicable), and may act as a localclient contact as assigned 
• Perform other duties as assigned by management 

联系方式
刘香莲
电话:1893****419
地址:北京市朝阳区建国路91号金地中心A座1501-1508室
该公司的其他职位
  • 生物制药[生物·化学]
  • 外资企业
  • 500-999人
手机扫一扫
随时随地找工作
简历投递成功
您可以在 个人中心 - 简历管理 - 我的简历 中查看您创建的简历
您可能感兴趣的职位:
关注微信公众号
投递结果早知道
联系时请说明是在医药人才网上看到的
正在获取二维码...
请使用微信扫一扫
客服服务热线
400-114-1987
微信公众号
手机客户端

Copyright © www.medrc.net All Rights Reserved

医药人才网 赣ICP备20010082号-3 版权所有

扫码下载APP