• Led a 4-member clinical operaƟons team supporƟng country-level acƟviƟes for a Phase 3 breast cancer trial, ensuring efficient trial execuƟon and adherence to Ɵmelines.
• Implemented site engagement strategies (PI Huddles, recruitment calls, newsleƩers), increasing paƟent enrollment by 60% in 4 months for a Phase 3 study.
• Contributed to strategic site selecƟon using data-driven metrics, collaboraƟng with Medical Science Liaisons (MSLs) and Clinical Science, resulƟng in a 62% higher site enrollment rate.
• Managed key lifecycle aspects for up to 3 concurrent Phase 1-3 oncology studies, including study start-up, enrollment tracking, study conduct support, and database lock preparaƟon acƟviƟes.
• Managed comprehensive study startup acƟviƟes: coordinated regulatory submissions, supported site Informed Consent Form (ICF) finalizaƟon, handled budget escalaƟons, ensured Site IniƟaƟon Visit (SIV) readiness, and verified site logisƟcs.
• Facilitated communicaƟon between clinical science

• Developed and negoƟated clinical trial budgets and Medicare Coverage Analyses (MCAs).
• Liaised between sponsors and internal teams for budget jusƟficaƟons and cost allocaƟons.
• NegoƟated clinical trial agreement budgets with sponsors.

• Served as interim supervisor, providing leadership and guidance to the team.
• Created and negoƟated clinical trial budgets for oncology-specific trials, demonstraƟng experƟse in ICD-10 and CPT coding.
• Conducted thorough reviews of contract language, ensuring compliance with regulatory and insƟtuƟonal requirements.
• Developed and implemented a clinical research billing program to ensure compliance with Medicare regulaƟons.
• Managed post-award finances, tracking paƟent payments, invoices, and budget/coverage analysis for protocol amendments.
• Provided experƟse in Medicare Coverage Analysis, conducƟng audits and training staff to ensure compliance.
• Wrote and maintained department SOPs for coverage analysis, ensuring standardizaƟon and best pracƟces.
• Provided financial experƟse support for PHI/PHII and SWOG trials
• DraŌed budgets for federal trials/grants and invesƟgator iniƟated trials
• Reviewed/provide oversight for clinical research billing charges in EPIC to ensu

• NegoƟated clinical trial budgets and payment terms with CROs and sponsors.
• Conducted Medicare Coverage Analysis (MCA) and ensured research billing compliance.

• Served as primary Coordinator for 10+ acƟve hemophilia trials; supported studies contribuƟng to 2 Food and Drug AdministraƟon (FDA) approvals.
• Prepared, submiƩed, and managed essenƟal regulatory documents for InsƟtuƟonal Review Board (IRB) submissions, renewals, and reviews.
• Maintained accurate and complete study documentaƟon (source documents, regulatory binders, trial logs) per regulaƟons.
• Created and negoƟated site-level clinical trial budgets.
• Executed clinical trial acƟviƟes (screening, enrollment, paƟent visits, follow-up) in compliance with FDA regulaƟons and ICH-GCP guidelines.
• Monitored paƟent safety, drug therapy compliance, and Adverse Events (AEs), ensuring Ɵmely reporƟng.
• Acted as the primary site contact for Sponsors and Principal InvesƟgators (PIs), ensuring study compliance.
• Trained and guided Assistant Clinical Research Coordinators.
• Organized and led weekly clinical trial team meeƟngs; prepared agendas and tracked acƟon items.