Constanza Taboada Email & Phone Number

• Start-up (from site identification through site activation): Act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.• Maintenance (from initiation through close out): Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments as needed during maintenance; Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval; Forecast, develop, manage, and revise plans and strategies for IRB/IEC and MoH/RA submission/approval; Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy. • Overall Accountabilities from Site Identification to Close out: Ensure timely and accurate completion of project goals and update of applicable trial management systems.

Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

Protocol: C3671013. RENOIR. A Phase 3 Study To Evaluate The Efficacy, Immunogenicity, And Safety of RSV Prefusion F Subunit Vaccine in Adults. Pfizer.Responsibilities:• Work according to principles and standards stablished by GCP/ICH guidelines, Clinic SOPs, QA/QC procedures, and Investigator 1572 Form.• Ensure informed consent has been obtained prior to performing any study procedures.• Perform all study responsibilities in compliance with the IRB approved protocol.• Review screening documentation and approve subjects for admission to study and then randomization.• Document all findings in subject specific source documents.• Provide ongoing assessment of the study subject/patient to identify Adverse Events.• Ensure proper documentation and reporting of all Adverse Events and Serious Adverse Events.• Perform physical examinations as part of screening evaluation and active study conduct.• Complete all study documentation in accordance with the study specific requirements.• Communicate with Sponsors and auditors as requested.• Monitor safety and well-being of study participants at all times.

Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

Protocol: CP-PRO-CoVLP-021. Randomized, Observer-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate Safety. Efficacy, and Immunogenicity of a Recombinant COVID-19 Coronavirus-Like Particle Vaccine in Adults 18 Years of Age and older. Medicago.

Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

Protocols:• mRNA-1345-P301. A Phase 2/3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), in Adults ≥60 Years of Age. ModernaTX, Inc.• mRNA-1010-P301A Phase 3, Randomized, Stratified, Observer-blind, Active-Controlled Study to Evaluate the Immunogenicity and Safety of mRNA-1010 Seasonal Influenza Vaccine in Adults 18 Years and Older. ModernaTX, Inc.

Argentina

Pharmacovigilance tasks including the identification, collection, and follow-up of adverse events, their progression and outcome; processing of safety data in accordance with both global and local regulations and guidelines; appropriate recording of Individual Case Safety Reports (ICSRs) in the database; and translation or supervision of relevant content translation. Preparation of analytical reports on daily and weekly quality metrics.

Argentina

Seguimiento epidemiológico de pacientes COVID+, evaluación de signosintomatología y comorbilidades. Detección de contactos estrechos. Gestión de traslado de pacientes a centros de salud u hoteles de aislamiento.Manejo de plataformas SISA, SISEP Y SIGEHOS.

Argentina

Atención por consultorio de pacientes pediátricos para la realización de examen físico completo y revisión del calendario de vacunación.

Grado En Medicina, Medicine, 9.15 / 10

Graduada con honores

Bachelor'S Degree, Bachillerato Científico Y Humanista, 9.20 / 10