• Collects, assists in preparation, reviews and tracks documents for the application process. Assists in timely submission of proper application/documents to EC/IRB and, where appropriate to Regulatory Authorities for the duration of the study.• Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents.• Serves as local administrative main contact and works closely with the CRAs and/or the LSAD for the duration of the study.• Operational responsibility for the correct set-up and maintenance of the local eTMF and ISF including document tracking in accordance with ICH-GCP and local requirements.• Ensures essential documents under their responsibility are uploaded in a timely manner to maintain the eTMF “Inspection Readiness”.• Ensures that all study documents are ready for final archiving and completion of local part of the eTMF and supports the CRA in the close out activities for the ISF.• Contributes to the production and maintenance of study documents, ensuring template and version compliance.• Vendor Management and Access Management.

• Supported and tracked all activities from study start-up to study close-out• Extensively involved in set-up, maintenance, quality review and tracking of clinical trial master file (paper and e-TMF)• Received and filed electronic and paper Clinical Trial/TMF Documentation• Managed the archival, tracking and retrieval processes for completed TMFs stored on or off site• Maintained the TMF index• Managed document review requests and resolved documentation issues• Set up, organized and maintained clinical study documentation, (study files, Crfs, preparation for internal and external audits, final reconciliation and archival)• Served as liaison for vendors and Clinical operations team• Supported the clinical document control efforts in preparing for and participating in audit and/or regulatory inspection• Supported internal and external audits• Supported the development of departmental metrics related to operational activities, quality measurements and other variables• Supported training and communication with user groups and information technology staff as related to TMF processes• Assisted in monitoring visit report review process, review of monitoring plan, TMF plan, TMF mapping Index and Communication plan • Monitored and tracked monitoring visit reports (per CTMS) and ensured that they are filed in TMF • Participated in clinical teams, including scheduling, attending required meetings, and interacted in a positive, professional manner• Collected and reviewed regulatory documents from clinical sites and communicated with sites regarding trial start-up, conduct, and close-out activities • Assess and review adverse drug reactions and related reports as per FDA guidelines• Undertook other duties as delegated by senior management• Assisted clinical project manager in general administrative activities as requested

• Performed set-up of the local Trial Master File (eTMF) and Investigator Site File including tracking of documents using Veeva Vault eTMF.• Maintained and closed the local Veeva Vault eTMF ensuring International Conference of Harmonization (ICH) Guidelines for Good Clinical Practice (ICH/GCP) compliance and local requirements.• Assisted clinical research teams in operational aspects of IITs and Cooperative Group studies, administrative and tracking projects, support meeting project goals• Ensured all documents are accurately processed in the TMF/eTMF (Veeva Vault) in an efficient and timely manner and adhering to Clinical File Room procedures in the filing, retention, and archiving of essential TMF documents.• Set up, organized and maintained clinical study documentation, (study files, Crfs, preparation for internal and external audits, final reconciliation and archival)• Setup and maintained clinical trial tracking systems and tools• Experienced in coordinate, order dispatch and tracking of trial materials• Acted as liaison between study teams and project management• Contacted clinical sites for missing documentation• Updated contracts, client presentation and file electronically• Demonstrated leadership capabilities and attended project team meeting and produce meeting minutes• Tracked and distributed safety reports, Fax, photocopy, and distributed study documents• Ship/mail supplies and documents to clients, investigator sites, and IRBs• Ensured appropriate trial agreements are signed and materials are distributed to the site and internally.