「臨床試驗專員Clinical Research Associate」的相似工作

1.協助執行臨床試驗專案管理的書面作業及文書處理。 2.與試驗團隊溝通試驗操作事宜，協助解決問題，確保專案順利推進。 3.設計、準備與管理試驗相關文件，確保文件品質符合規範。 4.協助試驗報告的撰寫、遞交與通報審查單位。 5.處理試驗專案的行政庶務工作。 6.完成主管交辦的其他任務。 7.CRA工作經驗二年以上。

執行試驗起始活動、試驗合約與經費協調、試驗文件與工具管理、試驗監測訪視、參與試驗各式會議、試驗進度追蹤與管理、執行試驗關閉訪視、協助試驗稽核與查核等等。

工作內容： 1.參與及協助臨床試驗相關計劃的送審、執行、監督及回報。 2.臨床試驗相關個案報告整理及追蹤。 3.協助臨床試驗監測及病人收案。 4.定期出差至醫院執行試驗監測、確保試驗收案符合預期、臨床試驗執行符合GCP、計劃書與相關法規規定。 5.醫院IRB各項行政與業務處理和維護、相關事務溝通協調 6.提供PI/Site選擇之評估建議與回饋。。 7.其他主管交辦事項。 工作型態： 需要出差到試驗單位(醫院)，查看臨床試驗的進度，並定期回報給臨床研究經理(CRM)，出差天數依據試驗案的進程而定。

1. 執行臨床試驗專案計畫 (臨床試驗申請、計畫進度追蹤及管控、聯絡協調、收案結果歸檔與統計分析)。 2. 聯繫臨床試驗法規單位、臨床試驗醫院。 3. 臨床試驗案的預算規劃和成本管理 4. 協助臨床追蹤結果之期刊論文發表。 5. 市場、相關研究文獻、法規資料收集與整理。 6. 與醫院進行IRB各項行政與業務處理維護。 7. 協助制訂和維護臨床操作標準程序。 8. 其他主管交辦事宜。 請參考本公司產品及資訊 http://www.sslab.com.tw/

執行公司內部臨床試驗，您將根據專案的時程接觸到CTA/SSU/CTC/CRA相關事務 1. 管理及協調CRO、SMO、中央實驗室及研發團隊，特別針對細胞治療專案，追蹤試驗進度與技術需求，並必要時更新實驗室手冊，確保符合GTP及相關品質標準。 2. 負責臨床試驗計畫書變更之FDA及IRB送審，供應商合約簽署與費用管理。 3. 確保試驗藥品及細胞治療產品的供應與使用，必要時更新藥品手冊，並協助監控細胞治療產品的製備、運送及品質控管。 4. 追蹤試驗偏差與不良事件（AE/SAE），協助制定及執行矯正與預防措施（CAPA）。 5. 整理試驗資料與品質控管，確保數據完整並符合GCP、GTP及法規要求。 6. 與跨部門及試驗中心保持良好溝通協調，支持專案管理及問題解決，並配合細胞治療專案的特殊合規要求。

1. 獨立作業而且能掌握研發專案的時程及成果交付。 2. 具管理內部資源之能力，控制部門/或專案活動之預算。 3. 臨床試驗文件撰寫和/或審閱。 4. 評估專案相關議題並研擬解決方案，與專案主管、團隊及外部合作者、委外供應者進行協調溝通。 5. 委外研究、CRO之評估、執行追蹤及品質管理。 6. 各國IND申請及臨床驗證之規劃及執行。 7. 具供應商管理經驗。 8. 具有CRA經驗尤佳。

1. 執行臨床試驗相關業務，包含試驗前準備、臨床收案、受試者追蹤，及試驗資料管理等； 2. 協助研究倫理委員會送審、管理臨床研究資料； 3. 協助計畫相關行政作業，例如計畫審查作業等； 4. 其他研究主持人交代事宜。

1.負責臨床試驗行政流程工作 2.協助按照臨床試驗計劃書完成相關流程 3.講述知情同意書及程序，並協助受試者招募、篩檢和安排檢查以及臨床試驗執行 4.臨床試驗收案監測、收案進度追蹤、試驗品質掌控與管理(彙整文件與歸檔)。 5.臨床試驗資料之分析彙整與會報。 6.協助臨床試驗稽核與查核及報告。 7.不良事件和嚴重不良事件通報 8. 確保試驗中心品質 9. 協助臨床醫師進行臨床是數據分析 10.部門主管或專案負責人交辦事項 11.有研究護士等相關經驗/背景者尤佳 【工作地點】臺大醫院 【工作待遇】依據國立臺灣大學計畫專任研究助理支給參考表；可依年資調整；享勞健保、年終獎金。

• Perform regular site visits to ensure that the site personnel are conducting the study in accordance with the protocol and ensure that any issues arising from the visit are documented in a visit report and addressed with the site in a timely manner. Any concerns or ongoing issues should be escalated to the Project Manager or Clinical Research Manager, as appropriate. • Perform feasibility study survey to identify the potential sites or strong the business opportunity. • Prepare and submit respective visit report in a timely manner after every site visit. • Communicate with investigators to obtain necessary documentation and information before, during and after the study on an ongoing basis, to met quality requirements of central and investigator site files. • Support RA team by collecting investigator site regulatory documents for regulatory and ethics committee/IRB submissions. • If appropriate, assist in generation of Clinical Trial Agreements according to standard and local country practices, and assist the sites in agreement completion prior site initiation. • Initiate investigational sites to ensure that they have a complete understanding of the clinical protocol and that they could abide by their obligations to conduct a clinical trial as required by applicable regulations.

工作內容 1.Develop budgets, proposals, and other related documentation for QPS domestic and global multisite and CRO clinical research activities. 2.Maintain compliance with Global Proposal Office processes, standards, guidance documents, templates, instructions from the line manager and Head of the Global Proposal Office, etc. 3.Effectively identify, communicate, and escalate issues, concerns, and feedback to the line manager on an on-going basis and in a timely fashion. 4.Communicate internal timelines and meet/exceed timeline commitments. 5.Provide regular updates and activity reports to the line manager and, as requested, the Head of the Global Proposal Office. 6.In accordance with Global Proposal Office scope and processes, accurately organize, file, and name information and update and manage information in SalesForce.com or other data capture system. 7.Process awarded projects in accordance with Global Proposal Office processes. 8.Prepare and assist in negotiations of assigned proposals/work orders, amendments and change orders and follow through to execution as required and escalate as appropriate. 9.Assist with creation of initial study timelines in cooperation with Global Proposal Coordinators, Clinic. 10.Contribute to team and departmental initiatives outside of day‐to‐day activities. 11.Other duties as requested or assigned by supervisor. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. 12.需兩年以上proposal coordinator 經驗或CRO 相關行業經驗 13.若有需求，可約40%時間居家工作。

1.Review, develop, and maintain regulatory documents and safety databases 2.Conduct PV: receiving, processing, submitting, maintaining safety cases/regulatory data, and medical coding 3.Establish and facilitate communication with study sites, the EC/IRB, and health authorities 4.As appropriate, assist Bestat and relevant parties in facilitating medical monitoring and regulatory processes, management, and policies

1. 具備醫療英文閱讀與檢索解析能力 2. 需撰寫創新醫材臨床試驗計劃書及臨床評估報告 3. 對新醫材/AI 開發驗證有熱忱與敏銳度 4. 熟悉SAS軟體或統計軟體程式 5. 三年以上工作經驗尤佳 .

*無經驗可，公司會進行工作技能相關訓練課程。 *科系要求：不拘 1. Assist investigators in preparing periodic safety reports during clinical trial execution. This includes communicating with hospital research staff to collect relevant trial data and compiling reports for submission to EC/IRB. 2. Track the review progress of periodic safety reports and manage timelines. Ensure timely reporting of review status to clients. 3. Support the application process for infectious sample shipment. Manage the validity of approvals from institutional biosafety committees and CDC. Plan timelines and apply for initial or extension approvals according to regulations. 4. Collaborate with SSU team members to provide administrative support for regulatory submissions. 5. Assist in the application for invoice issuance and handle other tasks assigned by supervisors. 6. Support contract amendments and budget changes with hospitals. Manage schedules and report progress to clients as required. 7. Provide routine administrative support for the SSU department. 8. No prior experience required. Training will be provided.

將依照過去經歷進行職稱及職等核定 臨床專案副理 工作內容: 1.臨床試驗專案主導、計劃與管理 2.撰寫臨床試驗計畫書 3.準備臨床試驗申請TFDA/US FDA之相關文件 4.協調、聯繫臨床試驗法規單位FDA，CDE 5.協調、聯繫醫院臨床試驗團隊與CRO 6.監測臨床試驗之進行 7.管理臨床試驗專案費用與時程 臨床專案專員(CPS) 工作內容: 1. 協助專案經理進行臨床試驗專案管理與進度推動 2. 協助醫院端費用與合約擬訂、簽約與管理 3. 協助試驗相關廠商費用與合約洽談、簽訂與管理 4. 協助合約付款追蹤與管理 5. 協助臨床試驗法規審查資料準備與送件 6. 其它交辦事項

1. 執行動物實驗、細胞試驗與分生試驗 2. 執行藥物篩選與臨床前試驗(藥理、毒理) 3. 試驗方法整理與數據分析整理 4. 藥物開發相關參考文獻搜尋與整理

1. 生體可用率/生體相等性試驗(BA/BE)規劃執行與專案管理 2. 臨床/臨床前試驗與檢體分析(PK/ADA)專案管理 3. 協調整合試驗團隊成員與外部協同合作單位之進度 4. 主導專案起始/規畫/執行/監控/結案分析並進行風險管控 5. 依目標需求控管試驗品質/時程/成本 6. 試驗委託單位聯繫與合約時程經費掌握 7. 主管交辦事項

1. 執行研究計畫。 2. 受試者知情同意說明 3. 負責報帳、經費申請、物品建檔等行政工作。 4. 操作並維護計劃或實驗相關的設備與儀器。 5. 協助資料收集。

Communicate with the trial team, trial sites and suppliers to ensure timely initiation and high-quality completion of clinical trials. Prepare clinical trial site qualification documents. Assist in reviewing the documents to ensure that the clinical trial sites comply with ICH-GCP and relevant local regulations. Key Responsibilities Include: • Assist clinical study team members in preparing, supervising and reporting of clinical trials in accordance with regulatory requirements and relevant standard opening procedures (SOPs) • Set-up maintain project filing for designated studies (paper and electronic filing systems for records) • Assist in preparation, correction, formatting of study-related documents (e.g. Protocol, Patient Information and Informed Consent Form etc.) • Assist in preparation of presentations for study teams members • Collect, file and distribute study-related documents (e.g. preparation and maintenance of Trial Master File (TMF)) • Assist the study team members in implementation activities where required. Preparation, collection of Regulatory and Essential Documents, facilitation of IRB/IEC submission and approval process • Preparation of Investigator Site File (ISF) e.g. for site initiation • Set-up and maintenance of tracking systems, reliably and efficiently input data into tracking systems to facilitate timely access by the study team members e.g. patients, sites, essential documents. Serious Adverse Events, CRFs and data queries as required for assigned projects • Take on any other task as assigned by manager or project team • Participate in relevant study/job related trainings • Assist in the planning and preparation of meetings, conferences and conference telephone calls • Provide general administrative support for personnel and liaise with HQ and subsidiary personnel as needed • Support site budget negotiation and site payment per site contract as needed • Support or directly perform IRB/EC and regulatory submission • Support or directly perform regulatory submission as needed • Provide support for audits/ inspections as needed • Support project team for import/export activities related to IP/non-IP supplies • Coordinate shipmen/ return/ destruction • Manage inventory and re-supply, as applicable • Support re-labelling in compliance with internal/external regulations • Act as primary administrator for customs clearance • Filing/ Copies/ Archiving Personal Skills: • Ability to work in a team and independently • Effective time management and organizational skills • Sense of responsibility

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward. One of FORTUNE’s ‘Most Admired Companies’, we offer unparalleled scope for a career in world-leading clinical research. Global projects, innovative tools and industry leading customers combine with outstanding support and clear career management which allows you to make a difference and to connect with great opportunities. Main Responsibilities: • Negotiate site contracts from the contract templates using appropriate guidelines, and collect necessary signatures for contract execution. • Negotiate site budgets from base budget and payment milestones using appropriate guidelines; complete final Schedule A for addition to contract. • Escalate contract and budget issues to Legal or Clinical Pricing & Payments Group and GCPM as appropriate to ensure Fair Market Value compliance. • Set up financial data, raise purchase orders and handle appropriate entries/requests into relevant financial and payment systems. Support Clinical Pricing & Payments Group in setting up sites for eGPS or legacy systems. • Track contract progression using appropriate systems. • Amend and terminate contracts as necessary throughout lifecycle of study. • Store and archive contracts and budgets in appropriate systems. • Maintain payment records and provide assistance with audit review records. • Responsible for reviewing and approving, with Law guidance, applicable changes within ICF part 2. • Responsible and/or point-of-contact at vendor level for the contracting process for locally outsourced studies. • Responsible for the Clinical Trials Insurance process. • Participate in appropriate site/legal meetings as required to resolve contract issues. • Participate in appropriate site/finance meetings as required to resolve payment issues. • Maintain party information and contract activation in Contract Generation System. • Approve or reject clinical invoices. • Process and track Confidential Disclosure Agreements as appropriate. • Manage contracting process with Clinical Trial Related Consulting Agreements. • Manage all study-related Site payments not managed by Clinical Pricing & Payments Group.

1. 臨床試驗法規審查資料準備與送件 2. 與試驗團隊聯絡及問題之溝通協調 3. 臨床試驗執行與收案進度追蹤 4. 臨床試驗監測與試驗品質控管 5. 臨床試驗相關資料整理歸檔 6. 其它交辦事項