三顧股份有限公司
(臨床試驗部)臨床試驗專員 (Clinical Research Associate, CRA)
10/21 Updated
Full-time
Mid to Senior Level
Salary & Location
Salary negotiable
(Regular monthly salary of NT$40,000 or above)
新北市汐止區
Required
Language Requirements
Chinese
聽/精通、說/精通、讀/精通、寫/精通
English
聽/精通、說/精通、讀/精通、寫/精通
Work Experience
1年以上
Job Description
✤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.
Number of Openings
1~1人
Educational Requirements
碩士以上
Field of Study Requirements
醫學系相關、藥學相關、其他醫藥衛生相關
Work Schedule
日班
Leave Policy
週休二日
Job Category
Other Medical Staff
Biotechnology Research and Development Staff
Pharmaceutical Research and Development Staff
新北市汐止區
其他電子零組件相關業
「三顧股份有限公司」於1998年成立，秉持「誠信、團隊、挑戰、樂觀」的經營理念，創造了優異的經營績效，並於2004年6月在台灣正式掛牌上櫃。 目前資本額為新台幣6.82億元，業務發展包含兩大事業群—電子與生醫。
近20年，三顧專注於電子零組件代理業務，產品應用領域包括：工業電腦、伺服器／儲存器、網通、電源及無線通訊產品。總部位於台灣新北市，並設有香港、深圳、新加坡子公司及北京、上海、成都、蘇州、吉隆坡、檳城、泰國、菲律賓、越南以及印度等分公司或辦事處，行銷據點遍布於台灣、中國與東南亞。
鑒於生技醫療產業為未來世界潮流與各國重點發展的項目，三顧於數年前積極組建專業的生醫團隊，冀望在既有電子科技領域之基礎上，能有效發展生醫業務。
2017年三顧公司與日本CellSeed公司簽約引進細胞層片培養技術，正式跨入再生醫療領域，目前不僅「膝軟骨細胞層片移植」收案人數全球第一，也因效果良好，除與國衛院群體健康科學研究所簽約，希望透過真實世界數據與真實世界證據申請查驗登記外，更開始進行異體膝軟骨細胞層片的開發，目前已完成動物試驗，效果良好。
此外，由三顧公司自行研發的「自體纖維母細胞M-Cell」，治療皮膚缺陷（皺紋、凹洞及疤痕之填補及修復），亦已與四家醫美診所合作提出特管法申請，將搶攻醫美市場。
2021年三顧與日立集團、國發基金等策略夥伴合資成立「樂迦再生科技股份有限公司」，預計在竹北生醫園區建置亞洲最大CDMO自動化細胞製造工廠。目前樂迦公司已擁有CAR-T、iPSC心肌層片等尖端技術製程，三顧集團將利用樂迦公司CDMO的平台，協助國內生醫業者開發各種細胞製程技術外，也將引進全世界最新的細胞治療技術，協助其在台灣取得藥證，透過與三顧集團合作的廣大醫院通路，讓更多有需要的病人獲得更好的治療，完成打造「台灣再生醫療生態系」的目標。
