「CRO CRA」找工作職缺－2021年6月 | 美體產業公開資訊

...個工作機會｜ExperiencedClinicalResearchAssociate臨床研究專員(一年以上CRAinCRO經驗)【台灣雙健維康生技顧問有限公司】、Clinical...台北市中正區.

Study startup which include IRB/IEC submission, site selection, recruitment of potential investigators, notifications to regulatory authorities, translation of study-related documentation Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned Study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned Site management as prescribed in the project plans Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs Independently perform Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Covance or clie...