Sheri Shubin

Senior Clinical Trial Assistant @IQVIA

Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g, Trial Master File (TMF) that track site compliance and performance within project timelines.• Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.• Assist with periodic review of study files for completeness.• Act as a central contact for the clinical team for designated project communications, correspondence, and associated documentation.• Collaborate with the clinical team on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.• Adhere to good clinical practices, operating procedures, and regulatory requirements.• System reconciliation for systems.• Assist with periodic review of study files for completeness.• Maintain and file essential clinical trial documents and completeness check of TMF.• Responsible for quality check of documents during filing.• Support in vendor access and site agreement workflow.• Generates custom reports to review eTMF.• Maintain Trial Master File (TMF) within a Clinical Trial Management System (CTMS)• Ensure TMF and ISF are always audit ready.• Maintain Investigator Site Files within a Clinical Trial Management System (CTMS)