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

灣 7. 需相關CRA工作經驗至少二年以上 8. 具有大型醫學中心或醫院相關臨床實務經驗至少二年以上 9. 歡迎曾有CRO公司服務至少二年以上經歷者

of the above requirement, -CRA II: candidates with 2 more years of CRA monitoring experience in pharmaceutical or CRO

* 與內部 CRA 或指定人員合作收集、審查和追踪試驗文件，以確保試驗文件和公司中央檔案的完整性。 * 提供持續的研究相關培訓（如 EDC）並在必要時為機構研究人員提供協助 *在試驗機構管理及清點臨床試驗藥物/醫材產品，以及臨床/非臨床用品庫存，

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。 臨

Research Associate (CRA) is responsible for site monitoring activities, data quality verification, and adherence to study

• 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.

* 與內部 CRA 或指定人員合作收集、審查和追踪試驗文件，以確保試驗文件和公司中央檔案的完整性。 * 提供持續的研究相關培訓（如 EDC）並在必要時為機構研究人員提供協助 *在試驗機構管理及清點臨床試驗藥物/醫材產品，以及臨床/非臨床用品庫存，

Demonstrated on-site monitoring experience 3. For CRA, 1+ years of experiences is minimum requirement, 2+ years of

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.

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

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. 相關報告準備與主管交辦事項。 7. 具有五年以上開發生技醫藥或藥食同源保健品之經驗者佳

條件 生物相關科系學/博士 具備同時間處理多項專案的能力 英語能力佳 有實驗室操作、動物試驗經驗(具CRO經驗、及GLP經驗尤佳) 工作內容 執行安全性試驗專案建立、數據檢閱、英文報告撰寫 on-line data collection

Your time here: At Parexel, the CRA role offers the opportunity to go beyond the role of a typical clinical monitor. CRA’s

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

Perform IRB submission activity, submission documents preparation, site fiscal management, clinical trial material management, site initiation activity, site monitoring activity, safety reporting

✤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.

試驗專案與人體研究案件團隊內外部人員的協調、合作與管理 5.所轄臨床試驗專案與人體研究案件執行的規劃與管理 6.參與專案CRO/Vendor的評估、遴選與管理 7.協助發展與建立部門的標準作業程序(SOP) 8.其他主管交辦的臨床相關業務

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.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.