「醫療器材臨床試驗助理 CTA (專案助理)」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。

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。

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

*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.

1. 臨床試驗專案計畫進度追蹤。 2. 專案計畫相關行政事務(資料彙整分析、會議記錄與檔案管理等)。 3. 主管交辦事項與進行專案事項之追蹤管理。

• 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.

1. 協助尋找受試者及聯絡事宜 2. 協助解釋試驗內容及受試者同意書填寫,體檢相關事宜 3. 協助試驗前場地佈置,用物準備，儀器維護，相關事宜聯繫 4. 協助試驗執行 5. 協助試驗結束後受試者體檢及營養費發放 面試地點：新北市汐止區新台五路一段104號7樓(明生總公司) 工作地點一：台北市中山區中山北路一段72號2樓(明生診所) 工作地點二：台北市中正區忠孝東路一段138號11樓(鍍生生技)

1. 受試者篩檢、招募和註冊。 2. 執行受試者試驗訪視。 3. 安排受試者檢查。 4. 將研究資料記錄到個案報告書。 5. 協助醫師處理研究藥物。 6. 不良事件和嚴重不良事件通報。 7. 維護原始檔案文件。 8. 確保試驗中心品質。 9. 其他主管交辦事項。

1. 配合委託單位協助準備專家諮詢會議及共擬會議等相關行政工作。 2. 其他交辦事項。 請至本中心網站【加入CDE】專區了解更多職缺訊息： https://www.cde.org.tw/joincde/1409/1999/13531/jobList

負責臨床試驗中心啟動、文件收集與送審、合約及預算談判。 Responsible for site initiation, regulatory document submission, and contract/budget negotiation. 維護研究中心合作關係，確保試驗順利進行至結案。 Maintain active collaboration with investigator sites to ensure smooth trial conduct and closure. 確保所有流程遵循 GCP、當地法規及公司政策，並維護試驗文件。 Ensure compliance with GCP, local regulations, and company policies, while maintaining accurate trial documentation. 管理臨床試驗物資、付款流程及相關財務事務。 Manage clinical trial materials, payment processes, and related financial activities. 協助流程優化，並在高階職級中領導跨部門協調與團隊指導。 Support process improvement, and in senior roles, lead cross-functional coordination and provide team guidance. ** 具臨床試驗或相關經驗： 有1-3年工作經驗，具備熟稔送審(含IRB、TFDA等)相關事宜，如有談預算/或合約經驗者更佳 ** 特休: 入職即可享用8天 第二年13天 病假:10天 旅遊補助:每年皆有1-3萬的補助可使用

1.安排受試者回診及進行相關檢查 2.收集檢測結果及資料整理 3.填寫個案報告表及完成相關文件 4.協助醫師依院內規定通報藥品相關不良反應 5.觀察受試者不良事件反應 6.作為受試者與試驗醫師之溝通橋樑 7.協助及配合臨床試驗監測與稽核 8.依臨床試驗計畫書, 藥品優良臨床試驗準則(GCP)及相關法規執行臨床試驗 9.主管交辦事項

1.國外醫療器材產品認證註冊申請作業(FDA 510K申請)。 2.國內外醫療器材法規認證事務及相關法規、標準之收集與更新。 3.國內外醫療器材查驗登記申請相關事務。 4.ISO品質系統維護及管理。

【職責】 協助財務部日常作業，包括： 1. 每日付款文件整理 2. 收集並掃描各部門提交之請款文件 3. 發送付款後之通知信件, 像是提供付款證明及支票之領取 4. 檔案管理 5. 其他主管交付的工作 【職位要求】 1. 學術背景：大學或碩士在學生，不限科系，商學院優先考慮 2. 工作經驗：不限，有財務會計相關實習經驗者優先考慮 3. 上班時間：每週至少到班三個整天，其中需包含週一跟週三 4. 學習能力強; 工作認真負責; 做事細心; 對數字有較高之敏感度

我們正在尋找一位法規事務助理，負責協助台灣及歐洲市場的法規相關工作。並具備良好的英文溝通能力，能與法規機構（例如:台灣食品藥物管理署 TFDA）進行互動，確保遵守地區性法規要求。 ***若具備基本法語能力者將優先考慮*** 工作內容： 1. 協助準備並提交台灣及歐洲市場的法規文件及申報資料。 2. 與法規機構（如TFDA）進行溝通，確保遵守適用的法規。 3. 審查並解釋法規要求，確保產品符合當地法規標準。 4. 協助準備法規檔案，包括註冊文件、產品標籤及技術文件。 5. 維護法規數據庫並追蹤申報及審批狀態。 6. 根據需要，進行法規文件和溝通的中英文翻譯。 Qualifications: Languages: Fluent in English and Mandarin Chinese (professional written and spoken communication required). Experience: Entry-level/junior position. Experience in regulatory affairs or related fields is a plus, but not required. Skills: Strong attention to detail, excellent written and verbal communication skills, and the ability to work independently. Education: A degree in life sciences, pharmacy, cosmetics, chemistry, microbiology or a related field is preferred but not mandatory. Other: Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint) and familiarity with regulatory databases is a plus. *此職位將涉及與法規機構的直接互動，需確保產品遵循所有相關法規。

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。

學歷要求：具公衛、流病、藥學相關領域碩士(含)以上學位者；具藥師執照者尤佳。 工作內容： 1.藥品、特材以及醫療服務的醫療科技評估業務。 2.醫療照護或社會福利方面特定主題的研究計畫。 3.業務相關行政工作。 4.其他交辦事項。 請至本中心網站【加入CDE】專區了解更多職缺訊息： https://www.cde.org.tw/joincde/1409/1999/13531/jobList

- 負責產品取證與國際法規申請（TFDA、FDA、CE） - 協助撰寫醫療軟體/AI產品相關法規文件 - 協助追蹤各國醫療法規與送審資料準備 - Handle certifications (TFDA, FDA, CE, etc.) - Prepare regulatory documentation for software/AI medical devices - Track global regulations and support submission

工作內容 1.Prepare and customize the Informed Consent Form. 2.Organize translation/verification of document required for clinical trial submission. 3.Planning the clinical trial submission timeline. 4.To be responsible for preparation of TFDA/IRB submission, including the comment reply until obtaining TFDA/IRB approval. 5.To be responsible for preparation of Interim report submission and Final report submission, including the comment reply until obtaining TFDA/IRB approval. 6.Apply for IP IL permit, infectious sample export permit, NCC application for 3C device import/export. 7.Good communication with study team, manage TFDA officer and IRB staff to meet the submission timeline, and propose the resolution to the client 8. Planning the clinical contract budget and negotiate with site clinical research center to fast the CTAg execution. 9. Familiar with TFDA/IRB requirements to support the team and answer the regulatory questions from the client. ＊無經驗可，公司會進行工作技能相關訓練課程。 ＊有實際做過TFDA /IRB送審工作，且兩年以上工作經驗者優先錄取，待遇從優。

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

工作內容 1、協助篩選合格的病患進入臨床試驗。 2、協助試驗主持人說明試驗同意書。 3、安排個案衛教、返診及追蹤。 4、追蹤計劃治療之療效與可能毒性，填寫個案報告表格。 5、與試驗醫院各部門溝通協調臨床試驗相關事宜等。 6、配合試驗計劃接受監測訪視與試驗醫院稽核。 7、主管交辦事項。 工作地點：林口長庚紀念醫院，桃園市龜山區復興街5號 工作時間：需配合計畫執行時程，彈性調整，以週休二日為原則。