Clinical Trials Assistant

The Clinical Trials Assistant will provide general project assistance to the clinical trial teams. You will perform administrative duties as assigned by the project manager that may include internal/external communications, writing meeting minutes, filing trial documents into the  Trial Master File system (eTMF on Sharepoint), and preparing site binders and material shipment. You will also have study coordination duties related to study start up activity, study data monitoring activity, product accountability and escalating issues to the PM.JOB FUNCTIONSCustomize and track contracts (drafted and standardized by the sponsor) for sites (dermatologist offices) during study start upArrange internal and external meetings (physical or online) with sites for Site Initiation Visits (SIVs)/ trainings/ escalation follow ups under the direction / supervision of PM. Produce minutes from the meetings.Managing the eTMF (study SharePoint) during study start up and execution and upload documents in the sponsor’s document management system, if applicable. Track and file ICH-GCP certifications,  essential study documentsAssist in collecting essential documents from sites for the Institutional Review Board (IRB) submission packagesPrepare the Investigator Level Binder and Site Initiation Visit materials for each siteData monitoring - Check on queries (data being out of range, items not being marked as completed for a completed visit, etc). Regularly send out list of compiled queries for sites to resolve and escalate as needed.Keep an up-to-date subject log (tracking enrolled vs drops)Send newsletters to the participating investigators, if applicableOrganize and document the shipment of study documents and supplies to the participating sites