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    更新于 12月1日

    臨床監查員cra

    1.2-2萬
    • 廣州越秀區
    • 1-3年
    • 本科
    • 全職
    • 招1人

    職位描述

    注冊藥物
    1. Conduct clinical site management related work according to company Standard Operation Procedures (SOP), Good Clinical Practice (GCP), and other authority laws and regulations
    2. Conduct and/or assist with site for study filling, initial EC submission/ EC opinion responds, clinical study agreement negotiation and others according to protocol and company SOPs
    3. Acting as the main line of communication between the sponsor and the investigator accordance with contracted scope of work
    4. Conduct site selection (if applicable), site initiation, routine monitoring and close-out visits in accordance with contracted scope of work
    5. If applicable, may be accountable for supporting developing project subject recruitment plan on a per site basis. Work with sites to adapt, driving and tracking subject recruitment plan in line with project needs
    6. Conduct monitoring visits and site management activities for a variety of protocols, sites and therapeutic areas
    7. Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
    8. Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
    9. Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution, safety information submission etc.
    10. Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
    11. Build awareness of features and opportunities of study to site
    12. Collaborate and liaise with study team members for project execution support as appropriate
    13. Other works which line manager or company assigned
    任職資格
    Education:
    ? Major in clinical medicine/nurse/ pharmacy/ pharmacological or other related, clinical medicine/nurse was preferred
    ? At least bachelor's degree and above was preferred. or other equivalent education background
    Experience:
    ? Previous working experience in clinical research related industry such as in hospital/medical institute/Contract Research Organization (CRO)/pharmaceutical or other similar
    ? At least 1year or above clinical trial working experience in CRO/Pharmaceutical company or equivalent experience

    工作地點

    廣州越秀區FOOPHOTOS商用圖片社(中華國際中心-A塔店)

    職位發布者

    劉圓夢/人事經理

    三日內活躍
    立即溝通
    公司Logo百試達(上海)醫藥科技股份有限公司
    百試達(上海)醫藥科技股份有限公司成立于2010年,是一家國際化創新藥物臨床開發機構,已連續兩次榮獲上海市科委高新技術企業稱號,服務范圍覆蓋全國多個中心城市和區域,下屬尚睿全資子公司,美國和澳大利亞控股子公司,現有員工已過千人。公司擁有資深專業研究團隊,主要研究人員均具有外資制藥企業藥物研發部和臨床研究部工作經驗,具有國際化、標準化的業務運作流程和科學嚴謹的質量保證體系,諳熟國際多中心臨床試驗和國內各種類型臨床試驗項目的運作和管理。公司總部位于上海,在北京、南京、廣州、成都、武漢設有分支機構,在美國波士頓及澳大利亞悉尼設有聯絡處和QA辦公室。百試達業務范圍包括臨床試驗的設計、組織、運作和管理,如I-IV期藥物臨床試驗和醫療器械臨床試驗項目的策劃和籌備、方案撰寫、基地篩選、臨床監查服務、藥物管理、數據管理和生物統計、研究報告撰寫。公司還提供藥品和醫療器械注冊和醫學咨詢和代理、流行病學觀察性研究、醫藥市場研究和研究者、CRA和其他臨床研究專業人員的培訓等。創新藥物研發包括化合物和大分子生物制品的篩選,活性藥物合成和制劑,化學藥物和生物藥品的國外專利技術的國內轉化以及相應的臨床開發。此外,百試達還在臨床醫學,臨床藥理學和生物統計領域擁有一大批專家網絡資源,并通過高質量的各類人員和項目培訓不斷擴大這一網絡,從而保證各類臨床項目的快速和高質量的完成。公司的合作客戶包括知名跨國制藥公司和醫療器械企業、國內研發型制藥企業、醫藥科研院所以及專業學術團體等。
    公司主頁
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