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.
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。
✤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.
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. 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. 聯繫合作的CRO公司與醫院臨床試驗團隊，跨部門協調與溝通。 3. 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。 4. 進度報告彙整。 5. 臨床試驗相關資料整理與
1. 管理並支援臨床試驗中心的臨床護理師收案相關事宜，協助費用報支申請。 2. 控管臨床試驗中心藥品與經費狀況，維持案件持續執行。 3. 控管委外檢驗報告的進度，匯總檢驗數據，申請費用報支。 4. 管理官方文書，匯整更新臨床試驗相關文件。 5.
(派駐國際前10大藥廠CRA) As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of
目前公司政策是，將公司優秀研究護士優先轉職成CRA。如對CRA工作有興趣，可以先在此職務中爭取認同。 -Perform study monitoring and site visit to ensure the rights and
1. 參與臨床試驗專案計畫規劃與管理 2. 試驗委託單位的聯繫及溝通協調 3. 協助撰寫臨床試驗相關文件 4. 臨床試驗經費控管 5. 主管交辦事項
「加入華廣生技股份有限公司，參與創新醫療科技的研發與臨床試驗，開拓國際視野，享受專業成長的機會。」 1. 主導第二類及第三類臨床試驗，包含： i. 計畫撰寫 ii. 合作機構洽談、合約與經費協商 iii. 醫院倫理與主管機
1. 新藥／健康食品相關臨床研究送審與執行。 2. 配合主管指示或經訓練後參與臨床試驗GCP 監測工作。 3. 研究專案進度追蹤、文件管理與經費管理。 4. 試驗團隊(醫院和受託研究機構CRO)聯繫及溝通協調，包含準備主持人會議。 5. 配合參與
a4e08b475d6a4176853c9d1cb9854e02 - The CRA Intern program is part time, will need to come to Taipei office 3 days a week. - Support Clinical
• 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. 協助執行試驗專案管理書面作業 2. 協助與試驗團隊溝通臨床試驗操作事宜 3. 協助試驗文件設計,準備與文件品質管理 4. 協助試驗報告內容遞交與通報審查單位 5. 試驗專案行政庶務 6. 主管交辦事項 * * 公司會提供錄取者: 完整的
CRA for BE study/New drugs/Medical devices 1.Clinical research study setup/study procedure setup/site staff training 2.
1. 協助臨床試驗的執行，包括聯繫與回報，以及行政作業的執行。 2. 與合作的CRO公司和醫院臨床試驗團隊進行聯繫，並協助跨部門的協調與溝通。 3. 臨床試驗相關資料整理與文件管理撰寫、歸檔。 4. 準備臨床試驗法規申請審查的相關資料 5. 其他
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. 聯繫合作的CRO公司與醫院臨床試驗團隊，跨部門協調與溝通。 3. 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。 4. 進度報告彙整。 5. 臨床試驗相關資料整理與
CRA負責對初級CRA進行培訓。 Experienced CRA is accountable for coach junior CRA.
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.
