* Performed administrative duties as needed * Proactively assisted to develop relationships with external customers * Managed project to assist clinical sponsor with trial recruitment needs * Arranged travel for approved patients * Collaborated with sponsor to ensure timelines and needs are fulfilled * Provided reports as requested

* Maintain various clinical systems that track site compliance and performance within project timelines * Assist the clinical team in preparing, handling, distributing, filing, and archiving clinical documentation and reports according to the scope of work and standard operating procedures. * Performed periodic reviews of study files for completeness and inspection readiness * Assemble and distribute study binders, CRF’s, site questionnaires and other supplies to clinical sites * Act as a central contact for the clinical team for designated project communications, correspondence, and associated documentation * Collect and track confidentiality agreements * Assist project managers and CRAs with developing/printing TMF binders * CRO oversite Ensures quality of data generated from clinical sites and assists in resolving patient eligibility and protocol deviation issues Show less

* Effectively support 2 protocols and over 100 global clinical sites * Track and monitor protocol training at site level * Support relevant aspects of clinical trials from initiation, planning, execution, and maintenance through close-out. * Review and track regulatory documents required for site activation * Oversite and track translations of study-related documents, i.e. protocol, ICF, etc. * Effectively perform periodic reviews of the Trial Master File to ensure inspection readiness * Track visit reports for Qualification Visits, Initiation Visits, Interim Monitoring Visits, and Closeout Visits on an ongoing basis and reconcile with site status * Tracked site enrollment status * CRO oversite * Provided custom reports as requested Show less

* Developed expertise in domestic and international travel * Managed average travel sales volume of up to $100,000 per month * Provided direct support to client base; proactively communicated via phone and e-mail; * managed heavy daily call volume of 110+ calls per day * Partnered with airlines to resolve client issues, secure refunds, and make itinerary * modifications- * Handled sensitive personal client information; ensure fraud protection * Completed extensive training in Global Distribution Systems including Amadeus, Sabre, * and Worldspan * Processed ticketing, validation, commissions, exchanges, refunds, and voids * Managed recruiting, training, and supervision of junior administrative/travel staff

* Effectively supported over 100 global clinical sites (2 protocols) * Serve as part of the Project Team and work on cross-functional teams on the implementation and management of client projects * Assist with site management, initiating collection, reviewing, and tracking of essential documents * Assist with project and site-level setup in the Clinical Trial Management System * Assist the clinical team with updating and maintaining clinical systems that track site compliance and performance within project timelines * Assist project managers, LCRA, and CRA’s with mailings to sites, faxes, regulatory documents * Facilitate/track site shipments and assist with sample handling and management Liaise with partners, vendors, and support groups such as ancillary supplies management, and establish good communication lines with various departments Tracks timely enrollment against plan * Ensures quality of data generated from clinical sites and assists in resolving patient eligibility and protocol deviation issues * Maintain eTMF Show less

* Provided direct support to travel clients including C-level executives and senior leadership; expertly handled all aspects of travel experience needs; created and managed itineraries * Oversaw client outreach via e-mail and phone; drafted correspondence * Managed travel bookings for flights, hotels, and ground transportation * Collected and processed payment for transportation and hotel accommodations * Created and managed client invoices * Conducted and documented process and system audits using written procedures as audit standards * Contributed to development and revision of Standard Operating Procedures (SOP) * Handled confidential personal client information and address verifications

* Directly supported clinicians and physicians with full-service travel and housing * coordination * Booked transportation including airline, rental cars, charters, etc. * Managed client communication via phone and e-mail; drafted correspondence * Researched housing options; negotiated terms and arranged lodging (hotels and short * term leases) * Managed effective formal and informal cross-functional relationships across * departments * Partnered with Housing Accounting to reconcile ledgers from properties with balance * dues and rental credits * Ensured Intent to Vacate notifications, furniture pick-ups (CORT), utility disconnections, * and other notifications or retractions were completed on time * Assisted with additional special administrative or operational projects as needed

* Attended/planned Investigator’s Meeting * Effectively support over 400 global clinical sites (1 protocol) * Assist with reviewing monitoring visit reports * Apply knowledge of company policies and standard practices to resolve problems * Participates in tracking and reporting study data for management reports * Assists CRA or other study team members with requesting, collecting, and reviewing site regulatory documents * Assist with study-specific document writing and review – (Protocols, ICFs, Source Docs, etc) * Assist in the writing, collection, distribution, and filing of meeting agenda and meeting minutes * Assist in audit/inspection readiness of eTMF * Collect site activation/start-up functions: CVs, FDA 1572s, lab certifications, IRB approvals, contracts, protocols, and ICFs * Assisted with FDA Inspection readiness and Mock Inspections – participated as a SCRIBE * Participate in the review of all supporting documents for a clinical study – Protocols, Statistical Analysis Plans, CRFs, Data Management Plans, Clinical Study Reports, etc Show less