Milantia S•••

About

On the record

I am an experienced Clinical Research Associate (CRA) with 7 years of expertise in vaccine clinical trials and over 19 years in the pharmaceutical industry. Fluent in Spanish and English, I bring a strong understanding of clinical trial operations across Puerto Rico, Honduras, Panama, and Dominican Republic, with proven ability to navigate complex regulatory and cultural environments. My expertise includes managing vaccine trials across Phases I, II, and focusing on multi-site studies, investigator relationships, and adherence to Good Clinical Practice (GCP) standards. I have extensive experience monitoring adverse events (AEs), serious adverse events (SAEs), and suspected unexpected serious adverse reactions (SUSARs), ensuring compliance with regulatory requirements. I am also skilled in managing laboratory samples using platforms such as Preclarus, ensuring accurate tracking and integration. I am proficient in key tools like Electronic Data Capture (EDC) platforms, Trial Master File (TMF/eTMF), Investigator Site File (ISF/eISF), and Clinical Trial Management Systems (CTMS), enabling efficient trial documentation and regulatory adherence. I have successfully managed the complete life cycle of vaccine clinical trials, from site initiation to monitoring and closeout visits. My responsibilities include patient recruitment, protocol adherence, data quality oversight, and maintaining patient safety. My leadership in multi-site projects ensures high standards of safety, compliance, and operational efficiency. With bilingual fluency, I collaborate effectively with site personnel, investigators, and stakeholders. I am skilled in addressing regional regulatory challenges and ensuring seamless trial execution tailored to local requirements. I am committed to optimizing recruitment strategies, improving operational efficiencies, and enhancing data quality. My technical expertise and dedication to patient safety and regulatory compliance allow me to drive successful clinical trials and contribute to advancing public health. I am passionate about clinical research and eager to contribute my skills and experience to your team. Sr Clinical Research Associate (CRA)| Certified Clinical Research Professional (CCRP) Expert in ICH-GCP| TMF | SDV, AEs/SAEs | Multicenter Vaccine Trials | Site Monitoring |Protocol Deviations & TMF Management.