職務概況
待遇面議
（經常性薪資達 4 萬元或以上）
台北市信義區
條件要求
語文條件
英文
聽/精通、說/精通、讀/精通、寫/精通
工作經歷
3年以上
職務描述
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。
Job purpose
Site relationship management role to ensure sustainable trial start-up at Site.
The Study Start-Up CRA is accountable for site selections as well as study-specific start-up activities
and deliverables of assigned sites for Phase I-IV GDD trials within the country in adherence with
monitoring procedures and processes in accordance with ICH/GCP, local regulations, and SOPS.
Proactive site preparation and early identification of real site needs and issues and close handover to
execution CRA for all sites is key (from issue management to risk identification).
Responsibilities
The Clinical Research Associate is ultimately responsible for the successful management of investigator sites throughout the trial lifecycle. Key responsibilities include:
1. Supports country SSU strategy in close collaboration with SSO Study Start-Up Team Lead, SSO Study Start-Up Manager, SSO Feasibility Manager as well as SSO Site Partnership Manager
2. Collaborates with SSO Study Start-Up Manager, SSO Study Start-Up Team Lead, and global study team to ensure Study Start-Up timelines and deliverables are met according to country commitments
3. Accountable for timely start-up activities from country allocation until site greenlight at assigned Sites
4. Conducts site selection visits, verifies site eligibility for a specific study
Main contact for trial sites during site selection, study start-up, and IRB/IEC and HA submission preparation
5. Ensures that milestones (KPIs) and time schedules for study start-up are met as planned.
6. Facilitates the preparation and collection of site and country-level documents
Collects submission of relevant site-specific documents (e.g., FD, CV, GCP certificates, DSL...) for all relevant site personnel within agreed timelines
7. Supports SSU Manager in preparation of country-specific documents, e.g... ICF, patient-facing materials, etc.
8. Supports SSO Study Start-Up Manager and assigned sites in vendor set-up activities
9. Prepare and finalize site-specific documents for submission
10. Negotiates investigator payments as needed
11. Supports preparation of financial contracts between Novartis and investigational sites and investigators as needed
12. Updates all systems until site Green Light on an ongoing basis
13. Supports preparation of audits and inspections as applicable
14. Supports reduction of formal site-specific IRB/IEC deficiencies
15. Ensures timelines, accuracy, and quality of the country and site TMF documents in study start-up to ensure TMF inspection readiness
16. Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority, and SOP requirements
17. Implements innovative and efficient processes which are in line with Novartis' strategy
18. Ensures sites are prepared for "Green Light" and is accountable to send the Green Light to SSU Manager for review and approval
需求人數
1~1人
學歷要求
大學(學院)以上
科系要求
醫藥衛生學科類
上班時段
日班
休假制度
週休二日
工作技能
Product Introduction and Explanation Sales
New Drug Research and Experiment Planning and Execution
產品介紹及解說銷售 新藥研發實驗規劃執行
職務類別
Other Health Professionals
Biotechnology Research and Development Staff
Pharmaceutical Research and Development Staff
