Maria Isabel Aguirre Cardeñp

Clinical Trials Coordinator at Universidad Pontificia Bolivariana-Clinica Universitaria Bolivariana
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Contact Information
us****@****om
(386) 825-5501
Location
Medellín Metropolitan Area, CO

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Experience

    • Clinical Trials Coordinator
      • Jan 2023 - Present

      • Preparation of clinical trials, involving planning, assembly and instructions to the team. • Verify subject safety and compliance with FDA regulations and ICH and GCP guidelines. • Schedule appointments and procedures required by study protocols. • Inform patients and/or caregivers about the aspects of the study and the expected results. • Ensure clinical study documentation in an organized and maintained manner (eg, Primary Study Files, eTMF, CRF, etc.), including preparation for internal/external audits, final reconciliation and archiving, as well as eCRF data entry, informed consent documents, query review and resolution. • Maintain required records of study activity, including case report forms, drug dispensing records, and regulatory forms. • Acquire specific clinical and therapeutic knowledge related to the studies carried out. • Guarantee a complete and exhaustive study on the reconciliation of medications. • Communication with laboratories or investigators regarding laboratory findings. • Work directly with the CRA on their monitoring visits. • Process data collection forms (ie, login, follow-up, QC as appropriate for the study) • Assist in quality control audits of clinical study documentation (eg, Main Study Files, CRF Files, Follow-up Files, etc). • Coordinate ordering/shipping and tracking of trial materials (eg, CRFs, journal cards, lab supplies, medication supplies, important communications, safety reports), as appropriate. • Coordinated translation of documents Show less

    • Bacteriologist
      • Mar 2022 - Jan 2023

      Process bacteriologist in the areas of chemistry, hormones, hematology, coagulation, microscopy, microbiology, blood sampling and nasopharyngeal aspirate for Covid 19. Process bacteriologist in the areas of chemistry, hormones, hematology, coagulation, microscopy, microbiology, blood sampling and nasopharyngeal aspirate for Covid 19.

    • Bacteriologist
      • Apr 2018 - Mar 2022

      Supernumerary bacteriologist, with rotating schedules, responsible for the service in the areas of chemistry, hormones, microbiology, hematology, coagulation, microscopy and transfusion service Supernumerary bacteriologist, with rotating schedules, responsible for the service in the areas of chemistry, hormones, microbiology, hematology, coagulation, microscopy and transfusion service

    • Bacteriologist
      • Dec 2017 - Mar 2018

      Responsible for the sample process in different areas, chemistry, hematology, coagulation, microbiology, microscopy and transfusion service. Equipment such as Dimension Rxl, Advia 2120i, Advia 560, Sysmex CA 600, Rapid point 400 and 500, Clinitek Advantus, Bactec Alert 3D and Grifols solutions and cards. Responsible for the sample process in different areas, chemistry, hematology, coagulation, microbiology, microscopy and transfusion service. Equipment such as Dimension Rxl, Advia 2120i, Advia 560, Sysmex CA 600, Rapid point 400 and 500, Clinitek Advantus, Bactec Alert 3D and Grifols solutions and cards.

    • Bacteriologist
      • Nov 2016 - Dec 2017

      Responsible for the processing of samples in different areas, immunochemistry, hematology, microbiology, coagulation and urinary biochemistry. Equipment such as Advia 1800, Advia Centaur XP, Architect i-2000, Micotest, Mindray BC 6800, Sysmex CA 1500, Sysmex CS 2100i, Fus 2000, Bactec 9240, Micro Scan Walk away 96 plus Responsible for the processing of samples in different areas, immunochemistry, hematology, microbiology, coagulation and urinary biochemistry. Equipment such as Advia 1800, Advia Centaur XP, Architect i-2000, Micotest, Mindray BC 6800, Sysmex CA 1500, Sysmex CS 2100i, Fus 2000, Bactec 9240, Micro Scan Walk away 96 plus

    • Bacteriologist
      • Feb 2016 - Jun 2016

      Responsible for the processing of samples from the clinic and from other entities that sent to the headquarters, areas of clinical chemistry, special areas, hematology, coagulation, urinary biochemistry which included the analysis of different body fluids, microbiology, arterial gases and transfusion unit. Management of equipment such as Cobas C-501, Cobas E-411, Sysmex XE 2100, Sysmex CA 500, Papid point 400/405, Bactec 9240, MicroScan Walkaway 96 Plus, Microtest 21, Alere Triage and Ortho Vision for immunohematology. Show less

    • Bacteriologist
      • Dec 2013 - Jan 2016

      Responsible for sample processing in the areas of microbiology, hematology, coagulation, microscopy and clinical chemistry. Support at the sampling sites when necessary. Management of automated equipment such as Architect C8000, Cell Dyn Ruby, Aution Max 4030, and semi-automated Diachek C4. Responsible for sample processing in the areas of microbiology, hematology, coagulation, microscopy and clinical chemistry. Support at the sampling sites when necessary. Management of automated equipment such as Architect C8000, Cell Dyn Ruby, Aution Max 4030, and semi-automated Diachek C4.

    • Colombia
    • Hospitals and Health Care
    • 1 - 100 Employee
    • Sampling bacteriologist
      • Sep 2011 - Dec 2013

      Responsible for taking blood samples, cervical cytology, vaginal discharge and cultures for different microorganisms; as well as carry out the adequate packaging for transport until their processing Responsible for taking blood samples, cervical cytology, vaginal discharge and cultures for different microorganisms; as well as carry out the adequate packaging for transport until their processing

    • Bacteriologist
      • Aug 2011 - Aug 2011

      Responsible for taking blood samples and cervical cytology. In addition, with responsibility for their processing in the areas of clinical chemistry, hormones, hematology, coagulation, microscopy and microbiology. Management of automated equipment Chemwell 2910, Sysmex KX-21N, Rayto 240 Responsible for taking blood samples and cervical cytology. In addition, with responsibility for their processing in the areas of clinical chemistry, hormones, hematology, coagulation, microscopy and microbiology. Management of automated equipment Chemwell 2910, Sysmex KX-21N, Rayto 240

    • Sampling bacteriologist
      • Mar 2011 - May 2011

      Responsible for taking blood samples and cervical cytology. Packaging and shipment to the reference laboratory for processing. Responsible for taking blood samples and cervical cytology. Packaging and shipment to the reference laboratory for processing.

    • Bacteriologist
      • Oct 2010 - Nov 2010

      Bacteriology responsible for taking blood samples and cervical cytology, vaginal discharge and cultures for different microorganisms. In addition to processing them in different areas such as clinical chemistry, hormones, hematology, coagulation, microbiology, microscopy and transfusion medicine. Management of automated equipment such as Ortho Clinical Vitros 250, Ortho Clinical Diagnostics ECi, Cell Dyn 3800, ACL 3000, Bactec 9000, Phoenix 100, Omni c for arterial gases. Bacteriology responsible for taking blood samples and cervical cytology, vaginal discharge and cultures for different microorganisms. In addition to processing them in different areas such as clinical chemistry, hormones, hematology, coagulation, microbiology, microscopy and transfusion medicine. Management of automated equipment such as Ortho Clinical Vitros 250, Ortho Clinical Diagnostics ECi, Cell Dyn 3800, ACL 3000, Bactec 9000, Phoenix 100, Omni c for arterial gases.

Education

  • Universidad Católica de Manizales
    Especialista en administración de servicios de salud, Administración/Gestión de servicios sanitarios
    2022 - 2023
  • Universidad del Rosario
    Diplomado, Terapias alternativas
    2019 - 2020
  • Pontificia Universidad Javeriana
    Diplomado en medicina transfusional e inmunohematologia, Servicios sanitarios/Ciencias de la salud, general
    2018 - 2018
  • Universidad CES
    Diplomatura gestion de la calidad en el laboratorio clinico, banco de sangre y servicio transfusion
    2013 - 2013
  • Instucion Universitaria Colegio Mayor de Antioquia
    Bacteriologo y laboratorista clinico
    2006 - 2010
  • Universidad Católica de Manizales
    Especialista en administracion de servicios de salud
    2022 -

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