「臨床試驗專員」找工作職缺－2021年6月 | 美體產業公開資訊

...【華廣生技股份有限公司】、臨床試驗專員(ClinicalResearchAssociate,CRA)​【...試驗專員【頂尖生技顧問股份有限公司】、臨床研究專員(CRA)【維州生物​科技 ...

✤Provide general administrative support to the Clinical Trial Department. ✤Communicate with investigational sites to collect all essential documents before the study start-up. ✤Preform TFDA submission such as initial, ongoing, amendment, safety reporting, and study notification per regulatory requirements and obtain the approval within the forecasted project timeline. Support IRB submission as needed. ✤Assist the Clinical operations teams with ongoing conduct of studies, including but not limited to the internal payment application process, study tracking update, document filing, document translation, audit preparation, and final reconciliation and archival. ✤Set up, prepare, distribute and maintain the study documentation and reports (e.g. Trial Master File (TMF), Case Report Form (CRF), etc.) according to the scope of work and...