• Processes (scans/images, indexes, files) incoming study documents (paper and/or electronic). • Assists study teams as required per WPD/SOP with filing or all documents TMF/eTMF and CRFs. • Liaises with the clinical study team to resolve outstanding issues identified during the QC/filing of electronic paper files. • Provides technical support for the study team when initiating the TMF. • Assists with applicable sponsor deliverables. • Performs Transfer/Archival or Central Archival related tasks. • Trains and mentors new department staff. • Works on special projects. Currently working to a specialized team for the Client Based studies. • Performs QC and uploads approved documents into the client’s Trial Master File system. • Provides process related training to Project Team, as necessary.