临床监查员助理 CRA I 上海

月薪： 0.8-1.6万/月

该公司所有职位
  • 无工作经验
  • 本科
  • 招5人
  • 01-25 发布
  • 五险一金
  • 补充医疗保险
  • 交通补贴
  • 专业培训
  • 年终奖金
  • 定期体检
  • 通讯补贴

职位描述

Position SummaryResponsible for the site monitoring and coordination of all aspects of clinical studies assigned in accordance with ICH-GCP, and local regulatory requirements, and the Standard Operating Procedures (SOPs) of Sponsor and /or dMed. CRA needs to be flexible to manage various projects and capable to handle different therapeutic areas and different studies . Build and maintain the working relationship with site and investigators. The degree ( I & II & III ) of responsibility accorded to a CRA will reflect their level of experience and contribution that they can make to the project.CRA II and III with extensive monitoring experience are required to be responsible to achieve project goals and assist junior CRA in skill and professional development. CRA II and III will display the leadership capabilities to a certain extent and be able to handle complex situation, and to take mentor role with CRA I or new comer when needed.Key Responsibilities- Operational Conduct of Clinical StudiesPre-study Activities- Assist Study Manager and sponsor representatives to sites and investigators identification and selection, including site feasibilities- Assist Study Manager and sponsor representatives with preparation of study budget- Prepare documentation for Ethics Committee submission and HGRAC application- Coordinate receipt and distribution of clinical trial supplies- Identify and source study supplies.- Liaise with investigators and site staff regularly to ensure effective initiation of studies- Develop appropriate monitoring tools- Support Sponsor& Project Leader to organize investigator meetings within budget.Site Monitoring Activities- Prepare and conduct initiation visits according to Study Monitoring Plan.- Oversee assigned clinical trials to ensure compliance with ICH-GCP guidance, local regulation, and the SOPs of Sponsor and/or dMed- Monitor and document the progress of assigned clinical studies through regular visits and telephone contact with site personnel following with Study Monitoring Plan- Liaise with Project Leader regularly on study status through monitoring reports and meetings- Liaise with other CRAs on study progress to maintain consistency if working on the same study.- Document all study related communications.- Perform Source Data Verification to ensure accurate data is recorded.- Ensure all Serious Adverse Events are reported timely and followed up according to Sponsor and/or dMed SOPs.- Maintain drug accountability of all clinical supplies and arrange for destruction as per specified clinical study.- Ensure study documentation for each clinical trial is complete and returned to Sponsor or dMed in accordance with set schedules.- Ensure documentation is maintained according to Sponsor or dMed SOPs.- Track study payments to ensure payments are on time and within budget.- Coordinate the resolution of data queries within a required timeframe.- Perform study closeout visits at the completion of database lock.- Support & coordinate with site to achieve site master files to ensure the competence and also to meet the requirements of site GCP office.- Review study reports when required.    - Reporting- Accurate completion of Monitoring visit reports with the required timeframe.- Ensure regular updating of trial tracking systems or templates .        - Prepare study progress reports for Project Leader/Sponsor by specified dates, which is copied to line manager    - Personal Development- Complete the dMed monitoring training program within the set timeframe.- Complete the dMed Safety Reporting Process: Overview training module in the set timeframe.- Attend and actively participate in personal development courses as required.- Attend training in specific therapeutic or clinical research areas as required.- Participate in TA knowledge, disease/indication training from dMed internal other functional lines as requiredEducation and Key Competency RequirementsProfessional Experience & Education Requirement- Minimum Medical or pharmaceutical education background or other life science degrees (or equivalent); clinic practice is preferred- With 2 years of experience in clinical trials preferred- Good working knowledge of GCP guidelines.- Proficiency in Basic Microsoft Word and Excel and familiarity with use of database- Knowledge of drug development process.Key Competency Requirement- Organizational commitment and result Oriented- Customer orientation and service mindset- Self-awareness and self-motivated- Well-developed of communication (Chinese & English), presentation, and interpersonal skills- Teamwork and collaborative working attitude- Able to plan, organize and prioritize various types of work and projects efficiently- Project management skills to deliver key milestones with high quality- Capability to identify issue and solve problems effectively and proactively- Resilient to changing project requirement or business needs with proactive approach- Continuously learn new knowledge and skills to keep up-to-date technical and disease area knowledge Ability to travel as neededImportant Note: The 'Salary range' in the job requirement is just for reference. The salary will be defined after full evaluation of the candidates through test and interview. 备注： ‘职位月薪’ 仅供参考，具体薪资和福利将根据候选人经验和能力综合评定。 职能类别： 临床研究员 关键字： CRA 临床监察员 Site Monitor

联系方式

上海 浦东新区 蔡伦路780号6楼Q座

公司信息

全球知名生物医药企业资深研发团队打造的创新服务公司。让你的职场起点更高，更充满挑战和精彩。 我们是谁？     基于中国面向全球制药，生物技术和医疗器械公司的临床开发服务和解决方案提供商:· 临床试验全程及专业领域服务：临床试验设计、数据管理及系统开发、生物统计及编程、运营和项目管理、报告撰写、注册运作和策略、质量保证和稽查、药物安全警戒和风险管理· 战略咨询服务：临床开发和注册策略、研发功能和架构设计、技术支持和国际化支持。 为什么选择我们？ · 缔脉定位于以高品质服务和专业精神成为业界典范。· 缔脉管理层在中国生物医药研发领域耕耘十多年培养了1000+优秀人才。· 缔脉致力于通过系统培训，研发实践和开放式文化培养新一代生物药物研发国际化人才。 创始人及部分核心专业领域创始人 - 谭凌实博士: 拥有20多年跨国一流制药公司总部高级管理经验. 此前担任辉瑞公司全球药物开发运营副总裁, 在中国成功创建了首屈一指的研发中心，且经历10多年发展壮大到多个地点,成为辉瑞全球核心的研发中心之一, 承担药物临床开发,安全风险管理, 注册,临床稽查等关键职能。谭博士多年为RDPAD, DIA 的核心成员，担任重要职务,包括研发委员会主席, 全球董事等。谭博士还带头建立了与国内一流高校的教育培训合作,比如复旦大学, 北京大学，交通大学. 培养了不少拥有专业技能和行业知识的临床数据管理和编程人才.谭博士有在美国建立初创企业的经验, 且在美国一流制药企业研发中心工作多年. 谭博士拥有生物统计博士学位。

上海相关职位
猎才二维码