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    • 上海复星医药产业发展有限公司
    • 所在地区：上海
    • 企业性质：国内上市公司
    • 企业规模：500人以上
    临床监察员 (11-9)
    分享到：
    • 工作地点：上海
    • 招聘人数：3人
    • 薪资待遇：面议
    • 工作年限：三年以上
    • 学历要求：本科及以上
    • 性别要求：-
    职位描述：

    职位描述
    RESPONSIBILITIES:
    1. Participates in site feasibility and/or pre-trial site assessmentvisits, providing recommendation from local area about site/investigatorselection in collaboration with the trial team
    2. Acts as primary local company contact for assigned sites for specifictrials.
    3. Attends/participates in investigator meetings as needed.
    4. Responsible for executing activities within site initiation andstart-up, site monitoring, site management and site/study close-outaccording to internal SOPs/WIs/IFUs and policies.
    5. Ensures site staff are trained and the corresponding training recordsare complete and accurate at any time point during all trial phases.
    6. Contributes to site level recruitment strategy and contingencyplanning and implementation in partnership with other functional areasto achieve clinical research target.
    7. Ensures site study supplies (such as Non-IP, lab kits, etc.) areadequate for trial conduct.
    8. Ensures that clinical drug supplies are appropriately used, handledand stored and returns are accurately inventoried and documented.
    9. Arranges for the appropriate destruction of clinical supplies
    10. Ensures site staff complete the data entry and resolve querieswithin expected timelines.
    11. Ensures accuracy, validity and completeness of data collectedattrial sites
    Ensures that all AEs/SAEs/PQCs are reported within the requiredreporting timelines and documented as appropriate. For AEs/SAEs, ensuresthat they are consistent with all data collected and with theinformation in the source documents.


    REQUIREMENTS:
    A minimum of a BA/BS degree is required. A degree in a health or sciencerelated field is preferred.
    A minimum of 3 years of clinical trial monitoring experience ispreferred.
    Specific therapeutic area experience may be required depending on theposition.
    Strong working knowledge of ICH-GCP, company standard operatingprocedures, local laws and regulations, assigned protocols andassociated protocol specific procedures including monitoring guidelines.
    Strong IT skills in appropriate software and company systems. Willing totravel with occasional overnight stay away from home.
    Proficient in speaking and writing Chinese and English. Good written andoral communication skills.
    职位要求

    • 临床医学

    • 本科

    • 3-5年

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    • 联系人：陆经理
    • 电子邮箱：点击查看
    • 企业地址：上海市徐汇区宜山路1289号A楼8F
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