Start-Up Supervisor (臨床試驗啟動專案主管)
面議(經常性薪資達4萬元或以上)
台北市中正區
2~3年工作經驗
工作內容
Perform start-up activities in assigned studies, according to applicable regulations, SOPs and work instructions.
Prepare site regulatory documents, reviewing for completeness and accuracy.
Inform team members of completion of regulatory and contractual documents for submission sites.
Distribute completed documents to sites and internal project team members.
Working closely with the Study Start-Up Manager (SSUM), Project Management team, and other departments as necessary.
Support the updating and maintenance of internal database, tracking tools, timelines and project plans with accurate and complete project specific information.
Review, track and follow up the project status, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF).
Review, prepare and negotiate site contracts and budgets with sites.
Other tasks assigned by the supervisor, SSUM
工作技能
1.具備TFDA及IRB至少2-3年以上工作經驗
2.熟悉ExPRESS及各IRB電子化送審平台
3.其他經驗: TFDA申請臨床試驗藥品進出口申請及展延, 生物安全委員會申請, 輻射防護委員會申請, NCC申請及展延等
4.臨床試驗經費評估及醫院合約協商
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