「臨床試驗助理(CTA)」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。

■ 臨床試驗協助 1. 協助臨床試驗送審行政管理作業 2. 負責試驗文件管理、相關單位聯繫、各項會議安排準備 3. 協助臨床試驗執行進度追蹤 (監測) 4. 協助臨床文件之資料填寫及文書編輯等行政層面支 ■ 臨床技術文件服務之協助 (臨床評估報告) 1. 臨床專案文件管理，包括點檢及管理文件、追蹤文件更新 2. 協助臨床專案相關科學文獻檢索、綜述和信息整合 3. 相關文件之資料填寫與整理、文書編輯等行政層面支援 4. 負責專案會議安排準備及進度追蹤 ■ 其他主管交辦事項 ※此職缺為公司顧問體系之專案助理或專員 (依經歷核定)，因組織擴張招募新血。

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。

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。

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.

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

• 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.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

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. 執行臨床試驗專案計畫 (臨床試驗申請、計畫進度追蹤及管控、聯絡協調、收案結果歸檔與統計分析)。 2. 聯繫臨床試驗法規單位、臨床試驗醫院。 3. 臨床試驗案的預算規劃和成本管理 4. 協助臨床追蹤結果之期刊論文發表。 5. 市場、相關研究文獻、法規資料收集與整理。 6. 與醫院進行IRB各項行政與業務處理維護。 7. 協助制訂和維護臨床操作標準程序。 8. 其他主管交辦事宜。 請參考本公司產品及資訊 http://www.sslab.com.tw/

1. 動物房與實驗室清潔與維護 2. 實驗動物飼育照護與籠具清潔 3. 協助研發試驗操作與執行(含動物人道安樂死) 4. 研發物料控管 5. 行政庶務、部門請採購 6. 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

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。

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

如果你是一位擁有醫檢師執照的專業人才，如果你對臨床試驗的檢驗分析有高度熱情，如果你渴望挑戰自我，我們需要你！ 我們正在尋找一位積極、具有創造力並對於檢驗分析充滿熱情的醫事檢驗師加入我們的團隊。作為我們的醫事檢驗師，你將可以在醫事檢驗所執業登記，並參與到檢驗前、中、後的活動。除了提供良好的工作環境並有免費的零食餵食以外，還有完善的教育訓練制度，我們同時擁有一個已有20多年美國病理學會(CAP)認證歷史的醫學實驗室，並致力於不斷提升自我，為臨床試驗中的受試者提供最好的檢驗服務。 如果你擁有生化、免液、血液與尿液、凝固學至少2項（如有分生plus），至少一年醫檢師的工作經驗，並在流式細胞儀分析、分子生物、病理檢驗染色、手工血清學有檢測或是方法開發經驗，那麼這是一個絕佳的機會，請盡快加入我們的團隊。同時，如果你擁有ISO-15189受訓證書或是有至少參加過一次CAP inspection的經驗，更是加分。 此外，我們歡迎積極、樂觀、勇於接受挑戰的個性的人加入我們的團隊。如果你渴望或是尋求機會可以跨足生技產業的行業展現自我，希望通過不斷學習和提高提升自我，那麼這將是一個絕佳的工作機會。如果你想脫離單調的醫院工作環境，請加入我們的團隊，開始一段全新的職業生涯。放下手中的鍵盤在靠北醫檢師社團的抱怨，期待你的加入！ If you are a licensed medical technologist with a passion for clinical trial testing and a desire to challenge yourself, we need you! We are looking for a proactive, creative and passionate medical technologist to join our team. As our medical technologist, you will be able to register for practice in the medical laboratory and participate in pre-analytical, analytical, and post-analytical activities. In addition to providing a good working environment and free snacks, we have a well-established educational training system and a clinical laboratory that has been certified by the College of American Pathologists (CAP) for more than 20 years. We are committed to continuous improvement and providing the best testing services for clinical trial subjects. If you have more than two years of medical technologist experience and have method development or analysis experience in flow cytometry analysis, molecular biology, pathology staining, and manual serology testing, this is an excellent opportunity to join our team. Furthermore, if you have an ISO-15189 training certificate or have participated in at least one CAP inspection, that's a plus. In addition, we welcome individuals with positive, optimistic, and challenge-accepting personalities to join our team. If you are eager or seeking opportunities to step into the biotech industry and show your talents through continuous learning and improvement, then this will be an excellent job opportunity. If you want to break away from the monotony of hospital work environments, join our team and start a new career.

1.進行動物醫院臨床訪視。 2.負責臨床相關試驗專案管理，進行對外說明公司產品特色簡報製作並回覆相關動物臨床用藥問題。 3.動物臨床法規查找、主管機關諮詢及審查文件研擬送件。 4.協助癌症新藥開發規劃及協助市場銷售專案。 5.其他主管交辦事務。

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. 執行動物實驗、細胞試驗與分生試驗 2. 執行藥物篩選與臨床前試驗(藥理、毒理) 3. 試驗方法整理與數據分析整理 4. 藥物開發相關參考文獻搜尋與整理

一、 協助臨床試驗執行 一、 毒理文件管理 1. 試驗文件與工具管理 2. 協助試驗稽核與查核。 3.針對產品毒理找尋文獻及各成分安全性評估。 4.產品系統檢核及資料庫新增。 二、臨床試驗 1. 試驗進度追蹤與管理 2. 執行試驗訪視準備 3. 協助IRB試驗計畫撰寫 三、 受測者團隊溝通 1. 協助執行試驗起始活動 2. 試驗合約與經費協調 四、 其他 1. 標準作業流程遵循、協助修改 2. 協助研發文獻搜尋 3. 協助實驗室或製程發派工作事項 4. 產品試用問卷設計及數據分析。 5. 產品儀器檢測及功效性評估。 6. 研究成分、撰寫產品說明書。 7. 研究化妝品成分及法規及相關文獻資料。 8. 對臨床實驗檢測有經驗者尤佳。