S

Santamarina Kretowicz

About

Detail

Buenos Aires, Argentina

Timeline


work
Job

Résumé


Jobs verified_user 0% verified
  • T
    Senior Clinical Research Associate
    Thermo Fisher Scientific PPD Clinical Research Services
    Mar 2024 - Current (2 years 8 months)
    • Manage investigator sites across global Phase II–III clinical trials, ensuring protocol compliance, patient safety and data integrity
    • Support site feasibility assessments, site selection and site activation activities in collaboration with sponsors and cross-functional study teams
    • Conduct Site Qualification Visits (SQV), Site Initiation Visits (SIV), Interim Monitoring Visits (IMV) and Close-Out Visits (COV)
    • Serve as a primary point of contact for investigators and site personnel throughout study execution
    • Review clinical data, source documentation and study metrics to ensure quality, completeness and timely issue resolution
    • Identify operational risks, implement mitigation strategies and drive issue esca
  • Fortrea
    Clinical Research Associate Ii
    Fortrea
    Jul 2023 - Mar 2024 (9 months)
    • Managed Phase II–III clinical trial activities and investigator site oversight
    • Conducted monitoring visits ensuring protocol compliance and patient safety
    • Supported study start-up, regulatory submissions and site activation activities
    • Reviewed clinical documentation, study metrics and site performance
    • Coordinated issue resolution with sponsors, vendors and site personnel
    • Identified and escalated operational risks impacting study timelines and quality
  • ICON Strategic Solutions
    Clinical Research Associate I
    ICON Strategic Solutions
    May 2022 - May 2023 (1 year 1 month)
    • Performed site management and monitoring activities for global Phase II clinical trials
    • Supported site initiation, monitoring and close-out processes
    • Assisted investigators and study coordinators with protocol implementation
    • Ensured compliance with ICH-GCP and regulatory requirements
    • Participated in study start-up and site readiness activities
  • PRA Health sciences
    Clinical Research Associate I
    PRA Health sciences
    Nov 2021 - May 2022 (7 months)
    • Conducted site qualification, initiation and monitoring visits
    • Verified source documentation and clinical data accuracy
    • Performed safety data verification and supported SAE reporting processes
    • Supported study execution, compliance and inspection readiness activities