Assistant

• Perform remote activities on assigned projects in liaison with the CRA and study Clinical Lead
• Support site preparedness and provide logistical support to the monitoring process
• Assist with site management and remote monitoring tasks in accordance with SOPs and regulatory guidelines
• Complete study and site management activities defined in the task matrix
• Complete and document study-specific training and learn study-specific systems
• Provide in-house support during pre-study assessments and waivers
• Customize Site ICF with site contact details as needed
• Perform remote EMR/EHR checklist reviews
• Verify document collection and RCR submission status; update site EDL and site information
• Review patient-facing materials and translations
• Support vendor qualification processes and site staff system access
• Follow up on site staff training
• Coordinate logistics for IM attendance and maintain vendor trackers
• Coordinate study/site supply management
• Support Essential Document collection, review and updating
• Follow up on missing vendor data including ECGs, lab samples and e-diaries
• Support remote review of centralized monitoring tools
• Support site payment processes, system updates, reconciliations and invoice follow-up
• Perform reconciliation tasks for CRFs, queries, deviations, SAEs and safety reports
• Verify document collection status and drive action on missing or incomplete documentation
• Perform other assigned site management tasks and FSP role profiles as directed
• Complete administrative tasks including expense reports and timesheets

Assistant jobs in Romania

Assistant CRA