「臨床研究專員(CRA)」的相似工作

- Responsible for all aspects of site management and monitoring of clinical trials - Manage interactions with all partners (investigators, site teams, internal company departments, external contractors, etc.) to facilitate successful conduct of clinical projects. - Support clinical research activities as assigned by the supervisor. - Build strong professional relationships with investigators, site staffs and internal/ external service providers. - Conduct initiation visits, monitoring visits and site closure visits in collaboration with the clinical project team. - Maintain the Trial Master File. - Prepare and negotiate site clinical trial agreements and manage clinical site budget and expenses. - Preparation of regulatory and ethics submission dossiers. - Ensure protocol-related safety reporting compliance and address and drive issue resolution. - Monitor site recruitment and establish/discuss action plans in close collaboration with the Clinical Project Manager. - Develop and conduct training for investigators and site staffs in the protocol, product and study-specific procedures. - Coordinate activities to ensure compliance with protocol, GCP, overall clinical objectives as well as company policies and SOP. - Manage trial product inventory, shipment and storage, and ensure accountability and traceability. - Ensure that imaging and/ or laboratory samples are collected, handled and shipped according to protocol requirements. - Ensure that safety reporting of adverse events is completed within required time periods. - Manage external vendor services for assigned clinical sites. - Identify issues which affect clinical trial progress and quality, and develop solutions and/ or take action to resolve/ prevent them. - Deliver projects according to expected targets, budgets and quality standards. - Monitor and report to clinical management teams on clinical trial progress, performance and plan, including subject recruitment and retention, monitoring activities, data completeness and quality, and site compliance. - Assist in the organization and conduct of internal and external stakeholder meetings, as required. - Set up, maintain and update clinical research activities and initiatives in the system.

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.

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. Assist the clinical team in the preparation and distribution of administrative matters and clinical trial materials. 2. Assists the clinical team in filing and archiving clinical documents and reports according to scope of instructions. 3. PK sample logistics management, material ordering and preparation, distribution to sites, and contact with logistics for sample delivery. 4. Complete other tasks or assignments requested by 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.

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.

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. 臨床試驗的規劃與執行，包括臨床試驗流程監控、Phase 1 臨床數據分析、Phase 1/2 & Phase 2 試驗設計所需之背景資料收集與解讀。 2. 規劃並推進 長效針劑產品 BE study，包含CRO選擇、資源配置與時程管控，確保與整體 研發計畫一致。 3. 進行臨床數據與 藥理/藥代（PK/PD）分析 之審查與解讀，並撰寫醫學與科學報告，以支 持法規申請與內部決策。 4. 協助安全性監測（SAE/AE 評估、signal detection）與真實世界/背景數據分析，確保受 試者保護與醫學合規性。

*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. 可獨立與外部單位合作完成田間試驗。包含但不侷限於合作單位評估、相關文件準備、研究單位接洽、執行過程之溝通、結果分析、報告撰寫等。 2. 負責執行公司研發專案所需之毒理試驗、田間試驗所需之相關工作。包含自行執行及委外執行。 3. 負責執行案件中各文件(包含但不局限於試驗計畫書、ICF、CRF、案件送審相關文件)之撰寫、執行中紀錄、數據分析、及報告撰寫等工作。 4. 收集與了解國內田間試驗相關之市場法規需求。 5. 彙整專案執行成果，打造產品臨床開發策略。 6. 公司或組織經營相關之主管交辦事項。

1. 職責與職位要求： *審查NDA/ ANDA製劑相關文件，確保其符合國際和地區監管標準 *與內部團隊協調，確保產品的合規性和註冊進度 *熟悉各國監管要求，確保提交的文件遵守各地的法規 *參與審查過程中的跨部門協作，確保項目的有效執行 2. 資格與技能要求： *具藥學、化學或相關領域背景 *至少有1年以上的藥品審查經驗 *了解國際藥品監管要求，包括ICH、FDA、EMA等 *強大的問題解決和溝通能力，能夠應對複雜的監管挑戰與協調合作 *英語口語和書面表達能力佳

As a Study Support Assistant (SSA), you will play a key role in independently assisting the team to ensure the most effective and efficient study start up, by providing administrative and tracking support. The Role • Supporting the Study Start up Associate with tasks including; tracking, filling, collating and verifying, for completeness, submission documentation for submission to the Regulatory/Competent Authority (CA)/Ethics Committee(EC) and other relevant authorities and helping with the translation of these documents • Looking after the submission progress tracking by updating the relevant ICON/Sponsor tracking system. • Be proficient with ICON/Sponsor Clinical Trial Management System (CTMS). • Setting, up, coordinate and maintain department electronic filing systems. • Coordinate and attend meetings as requested and assist in the production of slides, overheads etc as needed • Assisting in the co-ordination of payments to CA/EC and other relevant authorities and be familiar with ICH GCP and ICON SOPs What you need • The successful candidate will have a high school diploma, or local equivalent with good interpersonal skills and the ability to handle multiple tasks with meticulous attention to detail • Research or Healthcare related academic or work experience would be preferable but not essential • You will possess excellent written and verbal communication in English

工作地點：臺大醫院智慧醫療中心 職缺性質：兼職 1. 臺大醫院工作證申請: 於正式收案至少1.5個月前向台大臨床試驗中心申請臨床研究工作證（紅卡）暨研究案授權，確保取得工作證 2. 受試者招募: 試驗細節說明、協助受試者同意書簽署、依同意書資訊key-in受試者性別/年齡、給予受試者禮券(禮券保管) 3. NW500拍攝: 接受NW500拍攝訓練、拍攝眼底影像(一人2張)、每周整理NW500儲存的影像，提供給Sponsor 4. 配合Sponsor on-site monitoring活動 5. 醫院端庶務協助: 請PI/sub-I簽名相關文件、試驗文件管理與掃描歸檔、計畫經費核銷、協助儀器進出場相關事宜

Brief Position Description: The Site Management Associate (SMA) is responsible for planning, directing, and managing clinical trials at site. The SMA also implements remote site management activities according to the Site Management Plan, ensuring that clinical trials are conducted and documented, as per protocol, ICH GCP guidelines and applicable regulatory requirements and SOPs. 工作內容: 1. 協助醫師執行臨床試驗計畫 2. 完成資料及試驗數據之收集、記錄 3. 有研究護理師經驗者佳 4. 計畫及管理臨床試驗 5. 執行試驗場地管理 (依據試驗場地管理計畫) 6. 確保臨床試驗的執行及紀錄，是依據ICH GCP準則、本地及全球性的法規要求、諾佛葛及試驗場地的標準作業程序 Reporting to: As indicated on current organisation chart. Responsibilities: Conduct and complete remote site management activities and/or on-site visits according to the Site Management Plan. Specific duties include: Serve as a primary point of contact for site communication. Implement study start-up activities including but not limited to gathering feasibility information, negotiation of contract and budgets, planning for subject recruitment, communication with IRB/IEC. Collaborate with the principal investigator to prepare IRB/IEC and any other regulatory submission documents as required per protocol, ICH-GCP and local regulations. Ensure amendments to an approved protocol, informed consent form, and other relevant documents are submitted to IRB/IEC for approval as required and assure that changes are not implemented prior to approval. Arrange with monitor the scheduled date, time and location of site initiation visit. Prior to the site initiation visit, review the Investigator's Brochure and any up-to-date information on the investigational product for assessment of risk/benefit ratio of study participation in order to set Site Management Service Plan. Perform study-related tasks delegated by the principal investigator within the contracted scope. SMA is responsible for performing tasks appropriate for its role, unless otherwise noted on a protocol specific delegation of authority log. Support the investigator to identify suitable subjects for screening according to the eligibility criteria. If necessary, assist the principal investigator to use directed and IRB/IEC approved advertising (newspaper, TV, Internet advertisements, posters, etc.) materials. Provide written and verbal site updates on study progress to the line manger according to the study requirements/timelines. Ensure adequacy of information and data contained in site visit reports and other site management documents. Manage the site expenses of clinical trial including but not limited to subject reimbursement, material cost, travelling expense, cost for technical information, utilities and fees.

1. 基因檢測產品開發。 2. 期刊文獻收集閱讀。 3. 分析次世代定序實驗數據。 4. 執行次世代定序實驗與導入新興技術與應用。 5. 主管交辦事項。 【加分(薪)項目】 1. 具認證實驗室工作經驗，如 CAP、TAF/ISO15189醫學實驗室、或TFDA/LDTS實驗室。 2. 具次世代定序操作(Illumina、MGI、Ion Torrent)與應用經驗(WES、RNAseq等)。 3. 熟悉相關周邊儀器原理及使用(qPCR/BioAnalyzer/Fragment Analyzer/Qubit等。 4. 依據學歷及經歷調整薪資及助理研究員、副研究員或研究員職缺。

1. 臨床試驗專案執行之專案管理、進度管理及問題處理 2. 聯絡試驗醫院及CRO公司，與國內外廠商合作，跨部門協調溝通並了解監督角色與職責 3. 臨床試驗相關各國法規彙整，與國內外法規相關單位溝通聯繫 4. 臨床試驗案相關審查資料準備與技術性文件維持 5. 彙整專案進度報告及分析試驗數據、預算控管及請款報帳等作業 6. 試驗相關資料、文獻搜尋整理與其他主管交辦事項。 ★ 具CRO與藥廠經驗尤佳

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