Start-Up Supervisor (臨床試驗啟動專案主管)

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