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No.10106861 临床研究助理 Clinical Research Associate
立即申请
工作地 上海 税前月薪 30000 ~ 43000
职种分类 招聘年龄 26 ~ 45
语言 学历 本科以上
行业分类
工作内容 ? Review and/or input to study protocol, CRF, CRF Completion Guideline, Informed Consent Form and validation tools etc.
? Conduct/Assists in the submission to the Institutional Review Board (central and local) and to Competent / Regulatory Authorities
? Assists in developing of Investigator and Institution contracts, negotiates budgets and arranges site payments
? Participates to/Conducts Investigators selection/feasibility: e.g. phone contacts, questionnaire
? Conduct site qualification visits (pre-study visits)
? Conduct site initiation- and site close out visits
? Conduct regular monitoring visits: check of accuracy of study procedures, source data/document verification to ensure protocol compliance and that the clinical data are complete, logical and accurate, check consistency within CRFs, perform translation, collection of CRFs, follow-up of SAE, visit the pharmacy or designated Investigator facility (if applicable) to ensure that the Investigational Product(IP) has been adequately delivered, checks that there is an adequate stock, perform IP accountability control, checks that the storage conditions are eligible, that the storage temperature control is adequately documented and ensures the IP destruction or return
? Ensures that the site is equipped with all necessary supplies for timely reporting and that the procedures (sampling storage and shipment logistics) are appropriately adhered to
? Writes a monitoring report after each type of visit, in which the tasks performed during the visit and any problems encountered are reported, along with follow-up on any outstanding issues.
? Tracking of documents in CTMS
? Responsible for the quality of data from his/her own sites
? Resolves questions/issues with investigator/trial staff including query verification
? Manages his/her own visit schedule, appointments and the follow-up of issues between visits under, along with regular communication with the sites and the clinical study team

?审查和/或输入研究方案、CRF、CRF完成指南、知情同意书和验证工具等。
?主持/协助向机构审查委员会(中央和地方)和主管/监管机构提交报告
?协助制定调查员和机构合同,协商预算并安排现场付款
?参与/进行调查人员选择/可行性:例如电话联系、问卷调查
?进行现场资格考察(研究前考察)
?进行现场启动和现场收尾访问
?进行定期监测访问:检查研究程序的准确性、源数据/文件验证,以确保方案符合性和临床数据的完整性、逻辑性和准确性,检查CRF内的一致性,进行翻译,收集CRF,跟踪SAE,访问药房或指定研究机构(如适用)为确保试验药物(IP)已充分交付,检查是否有足够的库存,执行IP责任控制,检查储存条件是否合格,储存温度控制是否充分记录,并确保IP销毁或归还
?确保现场配备及时报告所需的所有用品,并适当遵守程序(取样储存和装运物流)
?在每种类型的访视后编写一份监测报告,报告访视期间执行的任务和遇到的任何问题,以及对任何未决问题的跟进。
?跟踪CTMS中的文件
?负责自己网站的数据质量
?与研究人员/试验人员解决问题,包括查询验证
?管理自己的访视时间表、预约和访视之间的问题跟进,以及与现场和临床研究团队的定期沟通

? Maintain close contact with the investigators on-site, the centre study coordinator, the pharmacist and other involved parties to be aware of any possible patient enrolments, the enrolled patients’ status, the IP stock and any further site requests or problems. The CRA informs the LeadCRA of any issues with the Institution
? Assists in filing and update of study documentation in the Investigator Site File and Pharmacy File (if applicable).
? Filing and update of the TMF or Project File within the Linical office throughout the study.
? Participates in relevant job/study related trainings
? Participates in investigator meetings
? Attend IRB meetings and explain study
? Obtain the latest information concerning safety issue of subjects (ex. abnormal values in LT, AE etc.) in a timely manner
? Receive SAE reports from sites, review the content and forward to client within established timelines
? Submit safety reports to the Head of Institution, IRB and PI
? Request IP shipment and follows up on delivery
? Request study material shipment and follows up on delivery
? Other work related to the above or works ordered by superiors

?与现场调查人员、中心研究协调员、药剂师和其他相关方保持密切联系,以了解任何可能的患者注册、注册患者的状况、知识产权储备以及任何进一步的现场要求或问题。CRA将与该机构有关的任何问题通知领导CRA
?协助研究人员现场文件和药房文件(如适用)中的研究文件的归档和更新。
?在整个研究期间,在临床办公室内归档和更新TMF或项目文件。
?参加相关的工作/学习相关培训
?参加研究人员会议
?参加IRB会议并解释研究
?及时获取受试者安全问题的最新信息(例如LT、AE等中的异常值)
?从现场接收SAE报告,审查内容,并在既定的时间内转发给客户
?向机构负责人、IRB和PI提交安全报告
?要求IP装运并在交货时跟进
?要求研究材料装运并跟进交付
?与上述相关的其他工作或上级命令的工程
申请条件 ■必要经验
最少具备全球企业的CRO行业或制药行业1年以上CRA工作经验
有现场启动和中期监测访问的监测经验

■附加资格
?根据良好临床实践(GCP)和适用的当地和国际法规和标准操作规程,负责研究的现场鉴定、启动、中期监测、现场管理和研究结束访问。
?确保研究现场提交的数据质量,确保及时提交数据,包括现场人员对所有安全事件的适当报告和跟进。
应能流利地使用当地语言管理研究site,能够与linical China team成员、研究人员现场人员、客户和供应商进行有效沟通。
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