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Work Background
LifeBridge HealthSpeech Language Pathologist, PRN
Aug. 2022 - Apr. 2024United StatesDelivered targeted therapeutic interventions using medical documentation and data analysis to improve patient outcomes; Collaborated with interdisciplinary teams on treatment plans, enhancing cross-functional communication skills relevant to trial operations.
I-Mab BiopharmaClinical Trial Assistant
Feb. 2022 - Apr. 2025United States, RockvilleSuccessfully coordination and managed of five clinical trials and 52 sites within two years, ensuring timely completion and adherence to regulatory guidelines; Enrolled 12/15 subjects prior to 6 month deadline using targeted outreach and site collaboration; Maintained and reconciled electronic Trial Master Files (TMF/eTMF) filing structures, ensuring inspection readiness and compliance of clinical trial documents contributing to 95% audit readiness; Stream lined the clinical trial documentation process, reducing errors by 40% and improving overall team efficiency; Tracked sample collection, shipment, and lab receipt across multiple study sites; coordinated with central labs and vendors; Supported development of study documents, routed approvals (e.g., ICFs, protocols), and submitted documents to regulatory bodies (e.g., FDA Form 1572); Collaborated with cross functional teams to ensure accurate collection of clinical trial data for database lock (DBL) prior to deadline and a 15% reduction in data errors; Reviewed and organized monitoring visit reports, Case Report Forms (CRFs), and site files in preparation for audits/inspections; Coordinated and documented clinical team meetings: prepared agendas, distributed materials, and finalized meeting minutes; Assisted with vendor management, contract routing, invoice tracking, and purchase order submissions in alignment with budget and timelines.
contractor/self-employedSpeech Language Pathologist
Dec. 2005 - Aug. 2021United States, DallasProvided comprehensive speech-language services to diverse adult and geriatric populations in skilled nursing, hospital, and home health settings; Managed medical data reviews and clinical notes, demonstrating transferable skills in compliance, documentation, and patient engagement.
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