目前公司政策是,將公司優秀研究護士優先轉職成CRA。如對CRA工作有興趣,可以先在此職務中爭取認同。
-Perform study monitoring and site visit to ensure the rights and wellbeing of trial participants are protected and the reported trial data are accurate, complete and verifiable from source documents.
-Good communication with Investigational Sites and Sponsor.
-Prepare and perform submission per global/ local and ICH GCP requirements.
-Ensure both Investigational Sites and Sponsor have copies of all essential documents as per ICH GCP and global/ local regulatory requirements, and that these are stored appropriately at the clinical trial site.
-Ensure any errors and omissions in study procedures at site are appropriately documented, including an explanation and suggestions to prevent further occurrences.
-Ensure project tracking systems are updated to reflect work performed at clinical trial site.
-Perform feasibilities to identify potential sites or confirm business opportunity.
-In collaboration with the PM, co-ordinate the services of sub-contractors to ensure the study are adequately supported, i.e. central laboratory, drug distributors/ providers etc.
-Provide general clinical support to the clinical project teams.
-Assist to prepare clinical trial agreement or contract with the sites and vendors if appropriate.