1.協助臨床試驗執行，包括試驗之聯繫與回報、行政作業執行。 2.臨床試驗法規申請審查資料準備，與國內外法規相關單位溝通聯繫。 3.協助控管臨床試驗預算與費用報銷 4.配合CRO，協助臨床試驗專案送審、合約與試驗啟動準備工作 5.配合CRO與醫

本公司已取得植物新藥第二期試驗許可 1. 溝通協調PI第二期試驗進行。 2. 協助研發記錄與專案技術文件。 3. 臨床試驗申請及相關事務協助。 4. 撰寫政府計畫申請並執行。 5. 善於溝通且主動、積極配合團隊合作。 6. 相關報告準備與

工作內容： 1. 臨床試驗審查資料準備與送件 2. 與試驗團隊聯絡及問題之溝通協調 3. 臨床試驗執行與收案進度追蹤 4. 臨床試驗監測與試驗品質控管 5. 臨床試驗相關資料整理歸檔 6. 配合醫院IRB各項行政資料整理、相關事務溝

✤Provide general administrative support to the Clinical Trial Department. ✤Communicate with investigational sites to collect all essential documents before the study start-up. ✤Preform TFDA submission such as initial, ongoing, amendment, safety reporting, and study notification per regulatory requirements and obtain the approval within the forecasted project timeline. Support IRB submission as needed. ✤Assist the Clinical operations teams with ongoing conduct of studies, including but not limited to the internal payment application process, study tracking update, document filing, document translation, audit preparation, and final reconciliation and archival. ✤Set up, prepare, distribute and maintain the study documentation and reports (e.g. Trial Master File (TMF), Case Report Form (CRF), etc.) according to the scope of work and Standard Operation Procedures (SOPs). ✤Order, dispatch and track the study materials (e.g. CRFs, diary cards, lab supplies, etc.) as appropriate. ✤Maintain the completeness of TMF at site and/or country level. ✤Organize and coordinate the team meetings and take meeting minutes. ✤Participate in the internal and external meetings, take meeting minutes and provide status updates as required. ✤Maintains a positive collaborative relationship internally and externally. ✤Participate in the development of protocols, informed consent form (ICF) and CRF as assigned. ✤Perform other duties as assigned by management team. ✤May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training. 1. Conduct site initiation, monitoring and close-out visits for assigned studies (includes project of Regulations of Special Medical Techniques (Specific)) in accordance with regulations, Standard Operation Procedures (SOPs), Good Clinical Practice (GCP), and Monitoring Plan (MP). 2. Deliver site training on the protocol and applicable regulatory requirements and perform site monitoring and management to ensure successful execution of the protocol. 3. Perform the study start-up activities, prepare the regulation submission and negotiate the site budgets. 4. Maintain the completeness of Trial Master File (TMF). Review the status and contents of essential documents and reconcile with TMF at site and/or country level. 5. Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, Case Report Forms (CRF) completion, and data query generation and resolution. Initiate appropriate actions to achieve study milestones. 6. Create and maintain appropriate documentation regarding site management, monitoring visit findings, correction plans, and action plans by submitting the visit reports, generating follow-up letters and other required study documentation. 7. Evaluate the quality and integrity of study site practices related to the protocol and escalate quality issues as appropriate. 8. Ensures safety and protection of study subjects through compliance with the MP, SOPs, and applicable regulations. Track and follow-up on Serious Adverse Event (SAE) reporting to ensure the reporting timeline meet regulatory requirements. 9. Collaborate with study team members for project execution support as appropriate. 10. Participate in the development of protocols and CRF as assigned. 11. Assist with training and mentoring of new employees as assigned. e.g. co-monitoring. 12. Act as contact for clinical trial supplies and other suppliers (vendors) as assigned. 13. Perform other duties as assigned by management team.

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

臨床試驗專員負責臨床監測與試驗中心管理的相關工作，須依據公司標準作業程序（SOP）以及國際協調會議（ICH）之優良臨床試驗準則（GCP）執行任務。藉由現場訪查，評估試驗是否符合試驗計畫書與法規要求，確保資料可信度以及受試者獲得妥善照護與治療。

負責北部醫院MV。 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

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。

研究機構展開 1.負責執行各階段臨床試驗。包含 CRO 之評選與合作、試驗中心與主持人之選擇、依據 ICH-GCP 進行臨床試驗、進度報告與試驗藥品不良反應報告等。 2.臨床前試驗計畫書之撰寫及送審。 3.臨床前試驗數據分析。 4.臨床試驗

1.負責臨床行政流程工作 2.研發文件管理 3.協助控管部門預算與費用報銷 4.協助臨床試驗專案送審、合約與試驗啟動準備工作 5.協助會議安排與舉辦 6.協助臨床試驗監測及病人收案.

▪ Independently interface with study vendors including but not limited to CRO, central imaging reader, eCOA vendor, central lab, medical equipment vendor and IP logistics in accordance with protocol/study requirements. ▪ Represent sponsor end to manage full life-cycle of clinical projects under the supervision of line manager and monitor study quality in accordance with regulatory requirements. ▪ Collaborate with study vendors to develop study core documents, study manuals, and other study materials. ▪ Assist with the internal administration activities including but not limited to study invoice handling and contract signing process.

Requirements: •B.A./B.S. (Life Science preferred) or equivalent healthcare experience. •Minimum 1 year experience as CRA. •In lieu

經常性事務 1.參與臨床試驗相關計畫送審、執行、追蹤。 2.整理篩選試驗適合執行廠商及相關之合約與經費協調、試驗文件準備。 3.協助試驗監測訪視、試驗執行進度管理、試驗資料整理、確保試驗執行符 合 GCP、計畫書與相關法規規定。 4.追蹤產業發展

【北極星藥業股份有限公司】 1. 配合臨床試驗需要，執行試驗進度追蹤 2. 監控臨床試驗醫療紀錄 3. 具有相關研究護士或臨床試驗工作經驗為佳 4. 熟悉新藥臨床試驗法規 5. 遵循ICH-GCP執行新藥臨床試驗 6. 工作範圍包括北台灣至南台

BE study/New drugs/Medical devices 1. Support study management activities for Project Manager. 2. Coordinate study logistics to meet project milestones. 3. Perform Site monitoring activities in compliance with GCP from pre-study to close-out. 4. Prepare project-specific support materials and templates in accordance with protocol and other specifications. 5. Communication between sponsor and site. 6. Contract negotiation of study budgets. 7. Manage activities and interactions with contractors, and/or vendors. 8. Audits/regulatory inspection preparation and participation upon request. 9. Provide mentorship and training to junior CRAs and other clinical staff as needed.

CRA for BE study/New drugs/Medical devices 1.Clinical research study setup/study procedure setup/site staff training 2.

1.負責臨床行政流程工作 2.研發文件管理 3.協助控管部門預算與費用報銷 4.配合CRO，協助臨床試驗專案送審、合約與試驗啟動準備工作 5.協助會議安排與舉辦 6.配合CRO，協助臨床試驗監測及病人收案. 想認識我們藥祇生醫，請參閱

Job Overview: Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions: • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. • Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability. • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase. • Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. • Collaborate and liaise with study team members for project execution support as appropriate. • If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. • If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

• 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.協助臨床試驗計畫管理與執行，CRO相關工作之協調與聯繫，審核相關的文 件和報告。 2.協助非臨床試驗進度追蹤、品質控管與專案管理。 3.維護及協助臨床試驗相關文件記錄更新及管理。 4.協助部門預算管理及費用核銷處理。 4.對於臨床試驗藥品開發