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取自临研通(天津)医疗科技集团有限公司近一年相关招聘职位
SCRA高级临床监查员
北京-朝阳区 |
3-5年 |
本科以上 |
2025-12-24
20000-30000
1.1Site Management Project Management中心管理与项目管理
Manage the assigned tasks clinical projects in 100% compliance with ICH-GCP, relevant SOPs, Local Regulations, other applicable laws guidelines, within the agreed timeline, including but not limited to: 在100%符合ICH-GCP、相关SOP、当地法规、其他适用法律和指南的前提下管理分配的任务或临床项目,并在约定的时间范围内完成,包括但不限于:
Building relationships with investigators site staff.与研究者和研究中心工作人员建立关系。
Conducting study feasibility survey site selection.开展研究可行性调查和选择意向中心。
Preparing required regulatory IRB/IEC submissions.准备所需的监管及IRB/IEC申报资料。
Providing training to study staff on conducting the project.为研究人员提供开展项目的培训。
Conducting local investigatmeetings, study nurse/CRC training, site Initiation.召开中心研究者会议,对研究护士/CRC进行培训,并启动研究中心。
Performing monitoring visits according to the approved Monitoring Plan.根据批准的监查计划进行监查访视。
Managing site Investigational Product (IP) supply management.管理研究中心试验用药品(IP)供应管理。
Conducting source data/document verification (SDV) in compliance with the Monitoring Plan data review timelines.根据监查计划和数据审查时间表进行源数据/源文件验证(SDV)。
Assisting ensuring site staffs complete CRFs answer data queries within the timeline defined in the Monitoring Plan.协助并确保研究中心工作人员在监查计划规定的时间范围内完成CRF和回答数据查询。
Completing monitoring visit reports required follow-up actions.完成监查访视报告和要求的随访报告。
Ensuring compliance of pharmacovigilance drug accountability.确保药物警戒和药品清点合规。
Being responsible fthe completeness quality of the on-site files.负责中心文件的完整性和质量。
Identifying resolving escalating any issues to PM CRM/ (A) CRD in a timely manner.及时识别并解决或上报任何问题至PM或CRM/ (A) CRD。
Closing out study sites on completion of the trial, ensuring no outstanding open issues.在试验完成后关闭研究中心,并确保不存在任何未解决的开放性问题。
Maintaining archiving study documentation correspondence.维护和存档研究文件和相关通信。
Preparing attending audit inspection as needed.根据需要准备和参加现场审核和检查。
Acting as mentrole model fother CRA team members to ensure study specific training fCRAs.作为其他CRA团队成员的导师和榜样,以确保为CRA提供研究特定培训。
Acting as a Lead CRA in assigned projects.在指定项目中担任首席CRA。
Performing co-monitoring visits with juniCRAs as required.与初级临床监查员进行联合监查访视或按要求进行。
1.2Relationship Management关系管理
Contribute to the establishment of a strong team spirit.为建立强大的团队精神做出贡献。
Establish maintain effective working relationships with other internal departments, including but not limited to: Medical Affairs, Regulatory Affairs, etc.与其他内部部门建立并保持有效的工作关系,包括但不限于:医疗事务部、法规事务部等。
Develop working relationships with regulatory authorities IRB/IEC personnel within the constraints of any local guidelines regulations.在任何当地指南和法规的限制下,与监管机构以及IRB/IEC人员建立友好工作关系。
Support the identification of new client relationships, further develop existing relationships with external personnel, including but not limited to:支持识别新的客户关系,并进一步发展与外部人员的现有关系,包括但不限于:
Personnel from client companies / potential client companies.客户公司/潜在客户公司的人员。
Investigators & site staff.研究者和研究中心工作人员。
Other institutional staff.其他机构工作人员。
Relevant healthcare professionals.相关医疗专业人员。
Knowledge Skill Requirementss知识和技能要求
Skills技能
Good communication presentation skills.良好的沟通和演讲技巧。
Good working knowledge of relevant software, such as MS-office (Excel, Word PowerPoint, etc).熟练掌握相关软件,如MS-office (Excel、Word和PowerPoint等)。
Strong attention to details.对细节的高度重视。
Ability to successfully work in a team environment.在团队环境中成功工作的能力。
Sound problem solving skills.良好的问题解决能力。
Ability to prioritize multiple tasks achieve project timelines.能够优先处理多项任务并实现项目时间表。
Able to take initiative work independently.能够主动工作,独立完成任务。
Effective time management inder to meet daily metrics team objectives.
Can travel frequently, up to 60%.有效的时间管理,以满足日常指标或团队目标。 可以适应差旅,*多可达60%。
Education教育
Bacheldegree above in medical, nursing, pharmaceutical other bio-science related area.医学、护理学、药学或其他生物科学相关领域的学士学位或以上。
Language Skills语言技能
Excellent writtenal skills in both local language English.精通当地语言和英语的书面和口头技能。
Minimum Work Experience*低工作经验
Experience of medical science related works.具有医学相关工作经验。
2-3 years CRA experience, global trials experience is preferred.2-3年CRA经验,具有全球试验经验者优先。
Demonstrating superimonitoring skills sound independent professional judgment.表现出卓越的监查技能和良好的独立专业判断。