Albert Radillo

• Served as the Site Lead for four study sites and liaised with Study Coordinators; ensured study required trainings were complete and current, collected and filed trial documents, reviewed and authored monitoring reports, and conducted remote Site Close Out Visits (COVs).
• Performed Central Monitoring of data and reviewed queries with Study Coordinators in the Electronic Data Capture (EDC) system in accordance with the study Monitoring Plan.
• Developed and formalized the process for collecting clinical trial equipment at end of study (EOS). Successfully collected all equipment from study sites, facilitated their return to the company warehouse for inventory or if leased, returned to vendor.
• Led and manged the transition onto a new Subject Payment system, after the original vendor suddenly went out of business and exceeded proposed timeline to remain in compliance with the Institutional Review Board (IRB).
• Inclusive of Clinical Department Responsibilities listed below.

Clinical Operations Department Responsibilities

• Served as the electronic Trial Master File (eTMF) Administrator for a Post Approval Study (PAS) and ensured the study file was in a inspection ready state. Responsibilities included vendor management, assignment and tracking of required training for Study Coordinators prior to start of delegated activities, providing site support, filing of documents provided by Study Coordinators and CRAs, and leading quarterly reviews and reconciliation activities with the study team.
• Served as the primary study contact for the Subject Payment system and ensured the Post Approval Study remained in compliance with the IRB. Responsibilities included vendor management, shipment of debit cards to study sites, assignment and tracking of required training for Study Coordinators prior to start of delegated activities, and providing site support for issues relating to subject payments.
• Managed study materials and clinical equipment by tracking on-site inventory, submitting orders to vendors for resupply, facilitating shipments to study sites, and filling shipping documentation into the eTMF.
• Supported Central Monitoring and Data Cleaning activities by generating minutes for Study Project and Monitoring Check-In meetings, generating metrics and tables to communicate progress of monitoring and query resolution, and collaborating with the study team to generate weekly Study Progress reports.
• Assisted with reviews and analysis of Tables, Listings, and Figures (TLFs) for FDA Annual Progress Reports, ensuring TLFs and critical data were free of errors prior to submission to FDA.

Regulatory Department Responsibilities

• Primary Company liaison for all product labeling including managing changes, standards compliance, and tracking of approvals and translations.
• Managed the selection, transition, and implementation of the company's electronic Instructions for Use (eIFU) website vendor to ensure continuing regulatory compliance and realize cost savings.
• Ensured compliance with regulatory approvals and Company SOPs by authoring a Regulatory Labeling reference file. Conducted an audit on all product labeling located in the regulatory file, Document Control, the eIFU website, and resolved all findings.

• Managed CRO on highly visible IDE study and performed regular quality checks in eTMF (Veeva Vault) and CTMS (Medidata). Escalated to appropriate persons when consistent errors were found.
• Prepared and compiled site documents from previous / ongoing studies to leverage for studies in start-up, which shortened site activation timelines.
• Creation of TMF Plan and TMF Index for new studies, worked with Project Managers and other functional teams to ensure relevant content was included and captured.
• Assisted PMs with filing of study documents in TMF, training assignments to internal team members, and management of trial supplies inventory
• Assisted with yearly annual TMF reviews and reconciled findings by communicating with other functional team leaders.
• Lead Clinical Records Representative on 4 different studies, ensuring studies are audit ready and compliant.
• Inclusive of responsibilities listed below

• Core Team member for high visibility medical device study, eTMF management for Study / Site level, and supported various Site Management Operations activities by working with in-House CRAs and PMs.
• Oversaw eTMF study overview status, by ensuring documents were not in draft states, escalated expired documents, ensured all study level documents were accounted for, and placeholders created for expected documents.
• Reviewed and ensured accuracy and completeness of clinical study documents, ensured GDP, and performed quality checks with limited supervision and direction.

• Worked closely with Project Managers on planning and executing multi-modality studies in which samples travel between Pharma Services Lab and Clinical Lab. These studies were monitored closely as samples traveled between multiple point of contacts and departments.
• Oversaw turn-around time for each case by promptly getting samples to lab and trouble shooting any queries, from sample receipt to reporting.
• Shipped Category B clinical trial samples domestically and internationally to various sites after testing.