CRA for BE study/New drugs/Medical devices
1.Clinical research study setup/study procedure setup/site staff training
2.Site monitoring visits/source data verification/deviation reporting in compliance with GCP
3.Trial documents maintenance/regular site visits and maintenance/study materials supply/interim reports
4.regular report to sponsor/communication between sponsor and site.
5.site close-out/trial materials retrieval
6.audits/regulatory inspection participation upon request
工作內容
1.Prepare and customize the Informed Consent Form.
2.Organize translation/verification of document required for clinical trial submission.
3.Planning the clinical trial submission timeline.
4.To be responsible for preparation of TFDA/IRB submission, including the comment reply until obtaining TFDA/IRB approval.
5.To be responsible for preparation of Interim report submission and Final report submission, including the comment reply until obtaining TFDA/IRB approval.
6.Apply for IP IL permit, infectious sample export permit, NCC application for 3C device import/export.
7.Good communication with study team, manage TFDA officer and IRB staff to meet the submission timeline, and propose the resolution to the client
8. Planning the clinical contract budget and negotiate with site clinical research center to fast the CTAg execution.
9. Familiar with TFDA/IRB requirements to support the team and answer the regulatory questions from the client.
*無經驗可,公司會進行工作技能相關訓練課程。
*有實際做過TFDA /IRB送審工作,且兩年以上工作經驗者優先錄取,待遇從優。