「恭賀 Fortrea 官方Line 2.0 全新上線！」的相似工作

This role is for upcoming future opportunities that may arise at Fortrea. Fortrea is excited to connect with talented individuals for future opportunities. If you meet the job requirements, we'll invite you for an interview. If you're pre-selected, our recruiter will keep in touch and let you know when the role officially opens, so we can reconfirm your interest before moving forward with an offer. Job Overview: Site monitoring and site management responsibility for clinical studies according to Company, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. Assures the implementation of project plans, as assigned. Summary of Responsibilities: Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned. Responsible for all aspects of site management as prescribed in the project plans. General On-Site Monitoring Responsibilities. Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study. Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements. Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible data. Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy. Ensure audit readiness at the site level. Travel, including air travel, may be required and is an essential function of the job. Prepare accurate and timely trip reports. Interact with internal work groups to evaluate needs, resources, and timelines. Act as contact for clinical trial supplies and other suppliers (vendors) as assigned. Responsible for all aspects of registry management as prescribed in the project plans. Undertake feasibility work when requested. Participate in and follow-up on Quality Control Visits (QC) when requested. Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned 18) Assist Senior CRA with managing investigator site budgets. Track and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs. Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management. Assist with training, mentoring and development of new employees, e.g., co-monitoring. Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned. Perform other duties as assigned by management. Qualifications (Minimum Required): University or college degree in a related allied health profession from an appropriately accredited institution. Basic knowledge of Regulatory Guidelines. Basic understanding of the clinical trial process. Fluent in local office language and in English, both written and verbal. Experience (Minimum Required): 2 years CRA experience with on-site monitoring experience. Oncology trial experience is MUST. Basic understanding of Regulatory Guidelines. Ability to work within a project team. Good planning, organization, and problem-solving skills. Good computer skills with good working knowledge of a range of computer packages. Works efficiently and effectively in a matrix environment.

1.負責核酸萃取及分子檢測試劑開發 2.產品性能設計、評估、驗證 3.產品與技術相關ISO文件整理及撰寫 4.專案執行及實驗室管理 5.研發專案計畫撰寫及文獻閱讀整理 6.跨部門溝通與技術服務協助 7.主管交代事項 1. Responsible for nucleic acid extraction and molecular assay development. 2. Design, assess, and verify product performance. 3. Organize and write ISO documents related to products and technology. 4. Project execution and laboratory management. 5. Write research project plans and organize literature readings. 6. Cross-departmental communication and technical service assistance. 7. Tasks assigned by the supervisor.

臨床試驗案件執行管理等相關工作 1.規劃及執行臨床試驗專案計畫. 2.協調參與試驗團隊，管控計畫進度並確保符合GCP試驗標準程序. 3.監督試驗過程與進度，並追蹤審查試驗成效. 4.專案障礙排除與危機管理. 5.合同項目執行規劃與驗收. 6.客戶關係維護. 7.監督試驗文件品質. 8.支援公司業務推廣工作.

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。

AIBEDA is a Contract Research Organisation (CRO) specialising in medtech and AI-powered healthtech innovation. The company provides end-to-end services, including regulatory strategy, clinical protocol design, technology assessment, and market entry support, to help clients navigate the global regulatory landscape. With a focus on agility, data-driven insights, and global connectivity, AIBEDA transforms complex regulatory challenges into commercial success. Are you passionate about clinical research? Are you excited about medtech breakthroughs impacting people’s health? If the answers are yes, we want to hear from you.

1.學名藥與新藥臨床一期試驗設計、計畫書撰寫、藥物動力學數據運算、試驗報告撰寫 2.臨床前藥物動力學數據計算與分析，試驗報告撰寫 3.藥物學術文獻彙整評估 4.法規單位函詢與意見回覆 5.台灣/歐美臨床試驗法規 6.一年以上相關工作經驗優先

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。

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。

We are seeking a Clinical Operations Coordinator to oversee the planning and execution of clinical studies in compliance with GCP/ICH guidelines and company SOPs. This role serves as the primary contact for clinical trial operations and manages day-to-day activities to ensure successful study completion. 1.. Study Oversight & Compliance - Lead planning, execution, and management of clinical studies. - Ensure compliance with GCP/ICH guidelines, applicable regulations, and company SOPs. - Act as the primary point of contact for all clinical trial operational activities. 2.. Team Leadership & Coordination - Manage day-to-day activities of the clinical operations team. - Provide guidance and oversight to ensure timelines, budgets, resources, and quality standards are met. 3.. Cross-Functional Collaboration - Work closely with clinical project managers, medical monitors, pharmacokinetics, data management, regulatory affairs, and pharmacovigilance teams. - Ensure efficient and effective study conduct through cross-functional alignment. 4.. Stakeholder Communication - Communicate study progress to internal and external stakeholders. - Identify and mitigate study risks and issues proactively. 5.. Site & Vendor Management - Oversee investigational sites and third-party vendors to ensure high-quality execution. 6.. Documentation & Systems - Ensure clinical project-related documents and systems are developed and maintained to high standards.

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。

(合作廠商: 生華生物科技股份有限公司) 公司以臨床開發為主、基礎研究為輔，致力於小分子抗癌新藥的研發，專注在「市場首見(first in class)」抗癌新藥開發，在資金、營運、智財、藥物合成、藥物製劑、動物試驗及臨床試驗等等管理之經驗豐富，隨著臨床試驗由一期進入第二期及三期，以及開發新的適應症應用，整合完備的資源，能提供合宜的培訓需求。 JD職缺說明: 職稱: 臨床前研究實習 • 具有規劃、管理及執行臨床前試驗/或是臨床試驗之能力。 • 具備基本分子生物實驗技術。 • 了解如何設計良好及合適的動物試驗，以充分了解試驗藥物的潛在風險和益處。

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.藥品查驗登記案之相關審查(包括:藥品上市後變更案審查、指示藥品審查、學名藥審查…等) 2.藥品風險管理計畫之評估與相關審查 3.藥品安全監視與不良反應通報之相關評估 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

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.原料藥、製劑，協助客戶於全球新註冊案件／缺失回覆及各項註冊變更。 2.原料藥、製劑，US/EU/TW 自有藥證註冊送件及變更。 3.自有藥證Life cycle maintenance及支援其他部門法規意見諮詢。

【Job Description / Capsule】 WHAT YOU WILL DO: - Collaborate closely with Marketing team in Oncology Business Unit to develop and execute campaign strategies and marketing collateral. - Support to manage the end-to-end campaign lifecycle, including content creation, approval workflows, execution monitoring, performance tracking, and data-driven analysis. - Serve as a liaison for internal teams and external vendors, ensuring clear and timely communication. - Provide logistical support for Marketing events, coordinating all associated operational details. - Oversee alliance coordination activities and maintain accurate data records. - Organize and facilitate internal meetings to support Marketing initiatives. Anne Yao Direct：02-7720-5802 Email：[email protected]

1.細胞培養以及生物醫學研究 2.細胞製程開發相關研發 3.從事新穎細胞培養媒介物及相關產品的研究、開發與改良 4.專案管理 5.其他主管交辦事項 其他說明 由公司補助交通費用(含機票)、海外住宿 ★★★須具備細胞培養經驗1年以上。★★★ 很抱歉，若無實務經驗者請勿投遞履歷

- 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

【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

1. Prepare and Submit Regulatory Documentation: Compile, review, and submit high-quality regulatory applications, such as Investigational New Drug (IND) applications, New Drug Applications (NDA), Abbreviated New Drug Application (ANDA), and Marketing Authorization Applications (MAA), to regulatory authorities. 2. Liaise with Regulatory Authorities: Act as the primary point of contact with regulatory agencies, responding to inquiries, providing additional data, negotiating requirements, and facilitating timely approvals or resolutions. 3. Monitor and Interpret Regulatory Changes: Continuously track updates in pharmaceutical regulations, policies, and industry trends, interpreting their impact and advising internal stakeholders (e.g., R&D, legal, and marketing teams) on necessary adjustments. 4. Ensure Product Compliance: Review and approve product labeling, packaging, advertising, and promotional materials to ensure alignment with regulatory requirements, including safety, efficacy, and legal standards. 5. Manage Regulatory Submissions Timeline: Oversee the preparation and submission process to meet deadlines, ensuring all documentation is accurate, complete, and submitted in accordance with agency specifications. 6. Maintain Regulatory Records: Organize, update, and archive regulatory documentation, correspondence, and approvals in a systematic manner to support audits, inspections, and future submissions. 7. Conduct Regulatory Risk Assessments: Identify potential regulatory risks or roadblocks in product development or marketing, proposing mitigation strategies to ensure compliance and project success. 8. Handle Post-Marketing Changes: Prepare and submit regulatory applications for post-marketing changes, such as updates to manufacturing processes, labeling revisions, or formulation changes, ensuring timely approval and compliance with regulatory standards.