Experience

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  Nyu langone health

  Sept 2021 - Mar 2023

  Program manager

  • Oversaw the conduct, progression, and compliance for 30+ internal and external sites of a multi-arm, multi-site domestic and international study with 2-7 staff/site • Responsible for Clinical Trial Execution and Management as Lead Coordinating Center: site initiation, activation, staff onboarding, staff training and development, compliance, and Regulatory and Ethics Committee review/submissions. • Created and distributed study materials, progress updates, sponsor reports, accrual reports, DSMB reporting, regulatory amendments, contract renewals, and ad hoc reports for stakeholders associated with the study. • Created ICFs, amendments, and statements of work for all existing and potential sites. Onboarding of potential sites for trial expansion. Review, edit, and negotiate contracts with external vendors and labs for trial needs for approval, renewals, and required amendments. • Developed and monitored SOPs and work processes to ensure efficient research operations. Created and maintained up to date trial materials (Protocol, Manual of Operations, SOPs, eCRFs, CRF Completion Guidelines, Training Materials, etc.).• Developed standards and served as escalation point for staff to monitor trial performance, adherence, and poor enrollment. • Conducted executive planning for the creation of multiple database buildouts for study. Identified gap areas and provided in-depth guidance and UAT findings within Trial Master to DataCore Manager with projected timelines for deliverables. • Generated and compiled study progress and metrics for sponsor, administrative leadership, and DSMB. • Monitored and troubleshooted interactions with Core Labs, trial supply donors, and shipping vendors. Contributed edits to budgets and contracted statements of work. Reconciled invoicing for Core Lab services, study milestones, and participant payments. • Supervised a large internal research team to ensure study metrics are met. Responsible for staff development and evaluations. Show less

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  New york university - college of dentistry

  Mar 2023 - Sept 2023

  Director, clinical research operations

  • Provided strategic plans and operational oversight for the NYU Dentistry Translational Research Center and NYU Oral Cancer Center for 15 faculty members to effectively manage and administer large-scale studies (multi-million-dollar NIH grants and industry sponsored projects).• Worked with Faculty to align center priorities with resources to plan and execute the delivery of projects to achieve center needs. • Oversaw financial management of all clinical research activities including budgeting, purchasing, invoicing, and forecasting future needs.• Made decisions relating to clinical research protocol feasibility for the college (review research protocols for the college’s ability to develop and execute the study). Supervised all operations from Protocol and SOP development, participant recruitment and monitoring, to close out; ensured adherence to regulatory compliance policies and GCP guidelines; assessed and implemented operational efficiencies.• Managed a Phase IIa multi-institutional clinical trial, focusing on start-up activities, enrollment, and cost-effective resource allocation. • Developed and ensured integrity of all clinical research data including database buildout, data collection and management, ad hoc reporting, clinical research sample collection and storage, and freezer management.• Developed and sustained relationship with Core Labs and MCIT senior leadership to implement center-wide biospecimen tracking software.• Supervised full-time research staff and exercised authority to make recommendations for hiring, promotions, and salary adjustments. Show less