职位详情
职位描述
  • 五险一金
  • 节日福利
  • 带薪年假
  • 晋升机会
  • 定期体检
  • 工作居住证
  • 弹性工作
Responsible for all aspects of study site monitoring including routinemonitoring an********-out of clinical s******** maintenance of studyf******** conduct of pre-study an******** visits; liaise with vendors;an******** ******** as assigned.
• Responsible for all aspects of site management as prescribe********the project plans
• General On-Site Monitoring Responsibilitie********
• Ensure the study staff who will conduct the protocol havereceive******** proper materials an******** to safely enter patientsinto the study
• Ensure the protection of study patients by verifying thatinforme******** procedures an******** requirements are adhere********according to the applicable regulatory requirements
• Ensure the integrity of the data submitte******** Case Report Forms(CRFs) or other data collection tools by careful source documentrevie******** Monitor data for missing or implausible data
• Ensure the resources of the Sponsor an******** are spent wisely byperforming the require******** tasks in an efficient manner, accordingto SOPs an******** gu******** including managing travel expenses in aneconomical fashion according to Covance travel policy
• Prepare accurate an******** trip reports
• Manage small projects under direction of a Project Manager/Director asassigned
• Serve as lea******** for a protocol or project an******** assist inestablishing monitoring plans as assigned
• Review progress of projects an******** appropriate actions to achievetarget objectives
• Organize an******** presentations at Investigator Meetings
• Report, write narratives an********-up on serious adverse experiences
• Participate in the development of protocols an******** Report Forms asassigned
• Participate in writing clinical trial reports as assigned
• Interact with internal work groups to evaluate nee******** resourcesan********
• Act as contact for clinical trial supplies an******** suppliers(vendors) as assigned
• Responsible for all aspects of registry management asprescribe******** the project plans
• Undertake feasibility work when requested
• Recruitment of potential ******** preparation of EC subm********notifications to regulatory author******** translation ofstudy-relate********, organization of meetings an******** tasks asinstructe******** supervisor as assigned
• Negotiate study budgets with potential investigators an******** theCovance legal department with statements of agreements as assigned
• Complete process of Serious Adverse Event (SAE) report******** processproduction of reports, narratives an******** up of SAEs
• Independently perform CRF review; query generation an******** againstestablishe******** review guidelines on Covance or client datamanagement systems as assigne******** management
• Assist with tra******** mentoring an******** of new employees, e.g.co-monitoring
• Co-ordinate designate******** projects as a Local Project Coordinator(with superv******** if applicable), an******** act as a local clientcontact as assigned
• Perform other duties as assigne******** management
职位要求
  • 专业要求: 药学
  • 最低学历: 本科
  • 工作年限: 1-3年
  • 职称要求: 中级
工作地点
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