「Site Activation Coordinator (Jr SSU/RSU)」的相似工作

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. - Assist Clinical Research Specialist (CRS)/In-house Clinical Research Specialist(iCRS), Clinical Research Associates (CRAs)/In-house Clinical Research Associate(iCRA) and Regulatory and Start-Up (RSU) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines. - Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files for completeness. - Assist CRS/iCRS, CRAs/iCRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information. - Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow. - Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation. - May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training and with required approval. - May perform assigned administrative tasks to support team members with clinical trial execution.

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。

ICON公司為全球前五大CRO 臨床試驗機構，全球第一大FSP公司，與全球頂尖的藥廠合作，提供專業的臨床研究服務。 提供員工良好且完整的教育訓練，透明的升遷制度，完善的休假制度，周休二日，讓員工能在良好的支援下為世界提供更新、更好的新藥品。 臨床試驗專員 1.藥品臨床試驗計畫啟動至結案過程的觀測及監督。 須具備良好的溝通能力以及敏捷的緊急應變能力，能跟試驗單位進行良好的溝通，並協助案件進行。 2.臨床試驗相關個案報告整理。須具備良好的檔案管理能力。 3.工作型態：需要出差到試驗單位(醫院)，查看臨床試驗的進度，並定期回報給專案經理，確認試驗持續符合計畫案的里程碑。出差天數依據試驗案的進程而定。 4.具備良好的英文讀寫能力，所有公司文件皆以英文撰寫。 5.目前需要具備一年以上的臨床試驗案進行經驗的人才。職級及薪水的核定將以面試來決定。面試有兩關，約在兩周內就會完成。 6. 歡迎持有身心障礙證件者投遞 Responsibilities The Clinical Research Associate is ultimately responsible for the successful management of investigator sites throughout the trial lifecycle. Key responsibilities include: 1. Full ownership of investigator sites for assigned studies with responsibility for the successful management of the site right through to close-out. 2. Planning and conducting various site visits (feasibility, site selection, interim and close-out) in accordance with the clinical monitoring plan. 3. Develop effective relationships with investigator site staff to ensure that key clinical metrics are met. 4. Preparing for and attending investigator meetings, coordinating the timely shipment and the subsequent proper storage and accountability of clinical supplies, and following up on drug safety issues. 5. Ensuring the integrity of clinical data through an ability to sufficiently maintain site tracking records and work diligently to relevant guidelines 6. Negotiation and ongoing management of clinical trial agreements with investigative sites.

*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. 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。

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。

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。

1. 負責臨床試驗專案的推動、管理、醫學評估，包括IND申請文件準備、試驗執行與GCP查核。 2. 協調內部與委外之工作，維持臨床專案品質並有效掌握專案時程。 3. CRO服務的評估、監督、審核及管理，確保其服務品質與合規性。 4. 藥物臨床試驗之法規遵循。 5. 跨部門相關事務之協助及臨時交辦事項。

執行公司內部臨床試驗，您將作為 PMS (project management specialist)，根據專案的時程接觸到 CTA/SSU/CRA/RA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.原廠溝通與技術整合 *與國外原廠聯繫，深入了解設備技術規格、操作原理及臨床數據。 *深入研究原廠提供的療程方案、配方、建議施作流程與預期效果。 *協助解決客戶在使用設備或療程時遇到的技術問題，並與原廠溝通尋求解決方案。 2.客戶端簡報與教育訓練 *針對合作夥伴、潛在客戶或醫美診所..等，進行專業療程簡報。 *根據客戶的屬性，結合現有療程，設計並提出整合性的療程規劃建議。 *負責對公司內部銷售、行銷及客服團隊進行新療程的教育訓練。 3.新療程研究與開發 *關注市場最新新趨勢。 *設計不同療程及提供方案。 *規劃並執行小規模臨床測試，驗證新療程方案的安全性與初步效果，並記錄詳細數據以供後續分析。 4.臨床試驗專案的執行，包括試驗之啟動準備工作，聯繫庶務行政工作等。 5. 與醫院試驗CRO團隊等溝通操作事宜。確保專案符合GCP 規範與順利推進。定期瞭解試驗進度並書面報告高層。 6. 協助定期維護試驗相關作業，例IRB報告的drafting, review與遞交，個案報告書即時通報台灣FDA與審查/法規單位。 7. 臨床試驗文件歸檔與系統管理，會議協調安排。確保文件品質符合規範。試驗資料轉換整合處理。 8. 執行主管交辦其他任務。

Administrative Support for PMs: • Support finance-related tasks such as budget tracking, invoice coordination, and application of project-related expenses and vendor invoices • Track and manage sample-related queries • Set up projects in Lab LIMS system • Assist with bio-sample import/export permit applications • Support Trial Master File (TMF) management and organization • Take meeting minutes and follow up on action items • Handle project-related document stamping and signature application processes • Assist in project documents for drafting or quality control (QC) • Facilitate internal communication and coordination across departments for project needs • Execute other ad hoc tasks assigned by supervisors Basic Project Coordination: • Manage assigned basic-level projects under supervision • Ensure project delivery aligns with agreed timelines, scope, and quality standards • Maintain clear and timely communication with internal teams and external clients • Support project tracking and reporting activities Qualifications: • Bachelor’s degree or equivalent in Science, Medical, or related field • 1–2 years of experience in laboratory operations, clinical trials, or administrative coordination preferred Skills and Competencies: • Familiarity with laboratory workflows and basic project management principles • Detail-oriented, organized, and proactive in task execution • Strong communication and interpersonal skills; English proficiency is a plus • Ability to manage multiple tasks and prioritize effectively • Proficient in MS Office and comfortable working with lab systems (e.g., STARLIMS) • Basic understanding of finance processes and document control in a regulated environment

This vacancy is open for talent pool collection. We will contact you if we have proper vacancies that fit with your profile. Job Mission Represent manufacturing and act as gatekeeper from manufacturing to D&E function Add value in overall manufacturing processes such as forming, machining, joining, and assembling Job Description Contribute to the solution of faults and takes the necessary initiatives and practical decisions to ensure zero repeat Identify gaps and drive assigned process improvement projects and successful delivery Initiate and drive new procedure changes and projects Develop and maintain networks across several functional stakeholders Prioritize works and projects based on business situation Transfer knowledge and train colleagues on existing and newly introduced products Education Master degree in technical domain (e.g. electrical engineering, mechanical engineering, mechatronics) Experience 3-5 years working experience in design engineering Personal skills Show responsibility for the result of work Show proactive attitude and willing to take initiative Drive for continuous improvement Able to think outside of standard processes Able to work independently Able to co-work with different functional stakeholders Able to demonstrate leadership skills Able to work in a multi-disciplinary team within a high tech(proto) environment Able to think and act within general policies across department levels Diversity and inclusion ASML is an Equal Opportunity Employer that values and respects the importance of a diverse and inclusive workforce. It is the policy of the company to recruit, hire, train and promote persons in all job titles without regard to race, color, religion, sex, age, national origin, veteran status, disability, sexual orientation, or gender identity. We recognize that diversity and inclusion is a driving force in the success of our company. Need to know more about applying for a job at ASML? Read our frequently asked questions.

1.須經常性進手術室裡教導醫師和護理人員正確使用產品 2.協助北區業務進行客戶開發及既有客戶的維持 3.其他主管交辦事項

具有以下經驗: 實質2年以上試驗案監測經驗 對於計畫書有深度的理解能力 蒐集資料並且適當解決 良好的溝通特質 精準的時間管理

1. Draft, review, and finalize clinical study documents in compliance with ICHGCP, applicable regulatory guidelines, and sponsor specifications, including but not limited to: ▪️Clinical study protocols and protocol amendments ▪️Investigator’s brochures (IB) and IB updates ▪️Clinical study reports ▪️Informed consent forms ▪️Briefing documents for regulatory meetings ▪️Patient narratives and safety summaries ▪️Clinical sections of regulatory submissions (e.g., CTD Module 2.5, 2.7) 2.Ensure scientific accuracy, clarity, and consistency of content across all documents 3.Collaborate cross-functionally with biostatistics, data management, clinical operations, medical affairs, pharmacovigilance, and regulatory affairs teams Interpret statistical and clinical data for integration into reports and summaries 4.Follow internal SOPs, writing style guides, and client-specific templates or standards 5.Maintain awareness of current regulatory requirements and industry best practices in clinical documentation 6.Assist in developing and maintaining document timelines, ensuring timely delivery 7.Respond to quality control or medical/scientific review comments and incorporate revisions accordingly 8.Hold PI meetings, and present protocols and clinical trial results to PIs and relevant personnel 9.Undertake other MA-related tasks as assigned by the line manager

The Researcher is responsible for the conduct of analysis related works according to GCP, GLP, CAP, Standard Operating Procedures (SOP), applicable Study Specific Procedures (SSP), and local regulatory requirements. Manage the operation of MT and aid physicians in the diagnosis, treatment, and prevention of diseases by testing patient specimens, correlating data, and reporting results in a timely manner to effect quality patient care. Responsibilities: Perform analysis work according to SOPs and guidance. Prepare, review, and approve various documents, including SOPs, protocols, reports, and analytical methods. Manage lab logistics, including purchasing, inventory control, and payment processing. Maintain instruments and ensure cleanliness and maintenance of the workspace. Take on the role of system owner for computerized systems, performing tasks such as validation tests, periodic reviews, and reporting. Attend training courses related to CAP/GCP/GLP/regulatory requirements. Study Based Responsibility (if needed) Analytical Study Director in Study Work as the Study Director, responsible for the overall conduct and final report of the study. Approve the study plan and any amendments by signature, and ensure Quality Assurance personnel receive timely copies. Make study plans, amendments, and SOPs available to study personnel. Ensure procedures in the study plan are followed and document deviations and take corrective action if necessary. Document and record all generated raw data. Validate computerized systems used in the study, sign and date the final report to indicate acceptance of responsibility for data validity, and ensure study materials are archived after completion. Study Personnel in Study Ensure personnel are knowledgeable in relevant Principles of Good Laboratory Practice. Provide study personnel with access to study plans and SOPs applicable to their involvement, with a responsibility to follow instructions and document any deviations. Emphasize the responsibility of all study personnel to promptly and accurately record raw data, comply with Good Laboratory Practice principles, and exercise health precautions to safeguard the integrity of the study.

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

本公司為積極前往國際市場，而擴大徵才，原設臨床研究處，擬擴大編製為三個單位，歡迎專業且富有經驗的臨床人才加入我們的團隊，共同推動多項適應症產品的臨床研究與應用，並在這過程中與公司共同成長、發展國際化的臨床及市場布局。 工作職責: 1.負責2-3個PTS潛力適應症專案之臨床資料收集及整理。 2.臨床試驗研究相關技術文件的制訂與資料分析作業。 3.準備EC、FDA送審文件(Ex: pre-IND, IND)。 4.監控進行中的臨床試驗，審閱臨床試驗報告；臨床試驗相關資訊蒐集與分析整理。 5.支持臨床項目管理活動，例如臨床試驗研究進展和醫學研究中心之可行性評估、病人招募、聯合監測、安全性資料或其它不同階段的研究活動。

1. Design CRF based on study protocol and prepare the CRF completion guideline. 2. Generate data management plan and data validation plan. 3. Clinical Data Management / Clinical data management status report. 4. Provide training to the site personnel and reporting agencies on proper data collection processes. 5. Coordinate with clinical monitoring activities to help provide prompt feedback to sites on data quality. 6. Establish data quality standards and works with reporting agencies to ensure standards are met. 7. Generate and close queries or apply self evident corrections to the data according to the relevant guidelines.

【職務說明】 1、線上減重諮詢服務及膳食建議 2、提供營養保健食品知識諮詢及產品建議 3、同理心提問與服務，並具有良好溝通能力 4、拍攝短影片 5、其他主管交辦事項 6、公司提供完善培訓制度，師徒制培訓(資深同事會從旁協助)，加速上手時間！ 【條件要求】 1、具有『國考合格營養師執照』 2、持續保持成長心態，勇於面對挑戰 3、喜歡熱忱為客戶解說 【公司福利】 1.一年3次績效獎金 2.端午節禮金 3.中秋節禮盒+禮金 4.生日禮金 5.婚喪喜慶補助 6.兩個月一次慶生會 7.五星級國內外旅遊 8.零食櫃 9員工進修補助 10.年終五星級飯店尾牙+摸彩 13資深員工禮金 14.兩個月一次部門聚餐 15.兩年一次高檔員工健檢