Yoselin Lugo

Background

About Yoselin Lugo

SUMMARY: · Twelve plus years of experience in clinical research, covering a wide range of medical disciplines. Medical data monitoring of safety and efficacy research studies conduction. Serious Adverse Event (SAE) and AE reporting, review and follow-up. Safety surveillance of research population. Protocol deviations discovery, reporting and resolution. Experience in monitoring duties, managing various projects, extensive skills in medical and technical literature review, collection of research data and preparing reports, studies conduct and management with direct support sponsors including but not limited to: CR Bard Inc, Boston Scientific, Terumo, Mayo Clinic, Stryker, Vesper Inc, Inari Medical, Gore Medical, Penumbra, and MicroMedical. · Monitoring and site management for a variety of protocols in multiple therapeutic areas · Conduct routine on-site/satellite monitoring visits. · Knowledge in FDA Audit preparation, support, and resolution. · Developed CAPA plans to address deficiencies and secure compliance. · Phase II-IV inpatient and outpatient studies. · Electronic Data Capture experience including but not limited to: Medidata RAVE, InForm, IBM, eClinicals, Oracle, Clindex, Syncrony, Medrio, Cenduit, iMedNet. · Aids Principal Investigators on specifically assigned experimental protocols in accordance with GLP standards. · Oversee outcomes and clinical research projects/drug/devices trails on different phases of national and multi-site design on topics. · Complete and ensure the accuracy of case report forms and regulatory documents, ensuring the adherence to GCP guidelines. · Respiratory: COPD, Asthma and Pulmonary Emphysema. · Cardiology: EBCT, CTA, MRI, CT Angiography and Ultrasound images acquisition and analysis. Images Data transferring to Data Analyzing Centers. · Medical Devices: Vascular and Endovascular (Invasive Cardiology, Oncology, Metabolic disorders, Interventional Radiology and Interventional Neuroradiology), including Nano drug delivery and tumor cells targeting drug deliver. · Clinical Trials Experience Quality Control. · Risk-Based Monitoring. · Clinicat Trial Management System (CTMS) experience : Velos, eProst, Veeva Vault, electronic Trial Master File (eTMF). · Experience with Institutional Review Board (IRB) Policies and Guidelines · SOP Review and Writing. · Knowledgeable in Regulatory Compliance: State and Federal Regulations, related to research regulations.