「臨床監測員 Clinical Research Associate, CRA (Contract-中部/北部地區)」的相似工作

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。

【 Job Description】  Responsible for clinical trial data management, including database design, validation, and maintenance  Draft and review Data Management Plan (DMP), Edit Check Specification, and other related documents  Perform data cleaning, and collaborate with CRA/CRC and biostatistics teams to ensure data accuracy and integrity  Handle data import, coding (e.g., medication, AE/SAE coding), and database lock procedures  Support the use and maintenance of data management systems (e.g., Medidata Rave, Oracle Clinical)  Collaborate with global teams, with strong English communication skills required; Japanese proficiency is a strong plus 【Requirement】  Bachelor’s degree or above in life sciences, pharmacy, biostatistics, public health, or related fields  Minimum 2 years of experience in clinical data management (CRO or pharmaceutical industry experience preferred)  Familiar with ICH-GCP and clinical data management processes  Fluent English communication skills (written and spoken) are required  Japanese proficiency is a strong advantage 【 應徵方式 】 - 方法一：投遞此篇104 - 方法二：直接投遞給我們https://reurl.cc/0W43pA *****小提醒*****在介紹自己的部分，告訴我們想看 CDM 的職位 - 方法三：加入官方Line 後輸入 CDM Line: http://lin.ee/gPk8luL Line: @ghchunting

in-house協助試驗起始活動之準備、試驗合約與經費協調、試驗文件與工具管理、in-house協助試驗監測訪視相關文件準備、參與試驗各式會議、試驗進度追蹤與管理、in-house協助試驗關閉訪視之準備、協助試驗稽核與查核、in-house協助健康受試者的招募等等。

- 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。

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。

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。

(1) 臨床試驗收案 (2) 採集檢體 (抽血...等)、問卷及資料建檔 (3) 具基本檢體處理能力，如離心、分裝...等 (或有意願學習者) (4) 協助交辦事宜

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

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. 協助醫師操作及使用醫療器材進行臨床工作。 2. 簡單產品諮詢服務與衛教。 3. 與客戶維持良好的互動關係。 4. 具相關經驗或無經驗肯學習者。 5. 護理背景尤佳 ※工作待遇含底薪+獎金

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。

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. 規劃並執行研究專案 2. 委外案件合約審查相關行政管理作業 3. 配合公司政策，完成交辦任務

1. 保健食品行銷文案撰寫 2. 保健食品營養科學文獻搜查、資料彙整 3. 可獨立作業細胞實驗模式建立、規劃與執行 (包含3T3L1、HepG2等分化型與免分化型細胞) 4. 協助產學合作、 實驗數據彙整與撰寫期刊發表 ►具食品與營養、生物等相關科系背景，碩士畢業 ►具有機能性成分開發或生理功效評估經驗者為佳 ►考核升遷制度 ►採季獎金制度，年薪70萬以上

工作項目： 1.協助移植外科臨床醫療及行政業務。 2.需配合工作輪值、加班。 薪資：無器官捐贈移植協調人員證書任職前三個月39,000元起，第四個月起約42,000元；具備器官捐贈移植協調人員證書任職前三個月42,000元起，第四個月起約46,000元 (以實際績效增減)。

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.

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 and project management? Are you excited about medtech breakthroughs impacting people’s health? If the answers are yes, we want to hear from you.

如果你曾經想挑戰一些跳脫日常的工作領域，卻又擔心離開醫院不知道能做什麼? 如果你曾經好奇透過護理專業能如何發展更大的影響力? 誠摯邀請你一起來跟我們聊聊。 金日科技（Aurum Care）是一家來自韓國的健康科技社會新創企業，致力於改善患者與照顧者在治療後的遵從性，進而提升生活品質。我們團隊與跨國藥廠及大型醫院攜手合作，共同設計創新的病患支持服務，以實踐我們的使命：「一次轉變一位患者的生命」。 在台灣，我們專注於創新病患支援專案，為台灣的罕病、癌症及其他重大慢性疾病患者與照顧者提供專業支持。這是一個開放且充滿挑戰的工作環境，我們誠摯邀請追求自我成長，關注患者與照顧者照顧議題，並想為他們創造價值的護理師夥伴，與我們一起改變生命的旅程！ 【工作內容】 • 整合對疾病和藥物的深度了解，提供患者或照顧者療程中的諮詢及相關資源 • 管理並執行該負責區域內各醫院的病患支援專案，依專案需求，定期與患有罕見、難治、嚴重疾病等特定疾病的患者或照顧者進行諮詢，觀察並回報潛在的不良反應 • 透過諮詢了解病患狀態，並管理與患者諮詢相關的文件、流程和諮詢紀錄