Bárbara Griñó

Clinical Research Unit - CRA Super User - AKA System Expert at ICON Strategic Solutions
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Contact Information
us****@****om
(386) 825-5501
Location
Chile, CL
Languages
  • Español Native or bilingual proficiency
  • Inglés Full professional proficiency

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Guillermo Casteller

I had the privilege of working with Barbara as her manager for almost one year at inVentiv Health Clinical Chile. Barbara is proactive, result oriented, responsible and technically sound employee. She is always ready to put all her energy and time to get the job done. Barbara is a great asset to any company.

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Credentials

  • Good Clinical Practice
    Clinical Trials Network, Inc.

Experience

  • ICON Strategic Solutions
    • United Kingdom
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Clinical Research Unit - CRA Super User - AKA System Expert
      • May 2020 - Present

      Although when reading the name of my role (System Expert) one would understand that I am a person dedicated to the computer science area, that is not the case. I am a person with a vast experience in Clincial Trials who works together with local and global teams in the systems used in clinical research. In many companies this role is Super User in some system. In this case, this role is focused on me. My tasks are to give training on the different platforms to the people of the unit, feedback at a local and global level on its operation and also participation in different local and global initiatives. I work very closely with Quality Leads since SOPs often have to have a practical translation in some system that allows it to be carried out. In summary, I am a person with a lot of experience in Monitoring Clinical Studies, who knows a lot about the systems used in clinical research. Show less

  • PRA Health Sciences
    • United States
    • Research Services
    • 700 & Above Employee
    • Clinical Research Unit - System Expert
      • Dec 2016 - Apr 2020

      Working at sanofi-aventis Chile.Main responsibilities1. Support to the local users (MT), in the implementation of the eCRF´s using at the site.2. Be the first support line to the users in CTMS in collaboration with the corporate team.3. Support to local team in the using of CTI reports, CTMS, Clubet.4. Follow up the adherence to the corporate requirements by the users of all systems.5. Identify and set up efficient process for managing and maintaining the support and services systems at the CSU team.6. Set the problems and communicate specific petitions to the corporate support teams.7. Contribute to the improvement of process and tools at worldwide level.8. Exchange experiences and solutions with systems experts within the region9. Back the data quality, by giving to the CSU team the training in better practices and guidelines (technical information eg. Compliance reports) and solutions of problems to local team.10. Responsible of creation and carry out of the necessary trainings for all supports systems, tracking of them (inside and outside) ensuring the correct communication with corporate.11. Assists the development and communication of local process of data privacy and ensures its adherence.Dec 2017 - today: people and training administration.Responsible to create training profiles and provide access to the local teams to the training platforms. Show less

    • Clinical Research Associate
      • Jul 2016 - Dec 2016

      Working at sanofi-aventis Chile.July 2016 to Jul 2017: working as CRA.Monitoring activities, phase III, respiratory studies• Monitoring tasks performed started from site activation, site initiation visits, monitoring activities, preparation and resolution of internal audits, preparation and maintenance of study files, etc.• eTMF: collecting, submission and tracking of documents uploaded to eTMF.

  • inVentiv Health Commercial
    • United States
    • Pharmaceutical Manufacturing
    • 400 - 500 Employee
    • Senior CRA
      • Aug 2015 - Jul 2016

      Monitoring activities, phase III, HCV studies • Regulatory tasks: preparation and submission of regulatory package to IECs. Customizations of ICFs and other regulatory documents. • Monitoring tasks performed started from site selection, activation, site initiation visits, monitoring activities, preparation and resolution of internal audits, preparation and maintenance of study files, etc. • eTMF: collecting, submission and tracking of documents uploaded to eTMF. Translation from local language to English of regulatory documents (including but not limited to submissions and approvals from regulatory authorities) for TMF purposes. • Translations: translation validation from English to Spanish of regulatory package: Investigator Brochure, protocol, ICFs. • Payment: management of investigator´s payments. Show less

  • Bristol Myers Squibb
    • United States
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Clinical Research Associate (CRA)
      • Jan 2013 - Jul 2015

      * Monitoring activities: oncology, inmunology (RA and Lupus) and infective (HIV). * Identify and selection of new sites. * Support in regulatory activities. * Develop of monitoring tools. * Monitoring activities: oncology, inmunology (RA and Lupus) and infective (HIV). * Identify and selection of new sites. * Support in regulatory activities. * Develop of monitoring tools.

  • Pfizer
    • United States
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Clinical Research Associate II (CRA II)
      • Jan 2011 - Oct 2012

      Monitoring activities of oncologic and inflamatory studies. · Phase III, kidney cancer. 3 sites, 20 patients.Ongoing · Phase III, psoriasis. 2 sites. 120 patients,Ongoing - Phase III, psoriasis. 2 sites. 60 patients. Ongoing. Monitoring activities of oncologic and inflamatory studies. · Phase III, kidney cancer. 3 sites, 20 patients.Ongoing · Phase III, psoriasis. 2 sites. 120 patients,Ongoing - Phase III, psoriasis. 2 sites. 60 patients. Ongoing.

  • Sanofi
    • France
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Clinical Research Associate
      • Oct 2008 - Jan 2011

      · Monitoring activities of oncologic studies. · Phase III, lung cancer. 6 sites, 20 patients. · Phase III, pancreatic cancer. 6 sites. 20 patients. - Phase III, prostate cancer. 6 sites. 60 patients. Ongoing. · Phase III, colorectal cancer. 3 sites. 15 patients. Ongoing.

    • Investigational Product Manager
      • Jan 2006 - Oct 2008

      · Management of Investigational Product: labeling, import, distribution, tracking and reconciliation, and destruction. It includes communication and coordination with Germany, USA, France and Argentina; local depot, Health Authorities and brokers.· Training of SOP, GCP to the members of the Clinical Research Unit of sanofi-aventis.· Training of management of Investigational Product to the Investigators in local Investigator's Meeting. Show less

    • Clinical Project Assistant
      • Mar 2005 - Dec 2005

      · Provide the organizational support for the Clinical Project Leader(s) and Clinical Research Associate(s) concerning the monitoring and report of the clinical studies assigned to Sanofi-Aventis Chile.· Management of the information and reports of Serious Adverse Event.· Preparation and submission of the Protocols to local Ethic Committees and Health Authorities.· Management of Investigational Product.

  • IQVIA
    • United States
    • Hospitals and Health Care
    • 700 & Above Employee
    • Regulatory Affairs Assistant,
      • Oct 2004 - Mar 2005

      · Preparation and submission of the Protocols to local Ethic Committees and Health Authorities. · Management of Investigational Product. · Preparation and submission of the Protocols to local Ethic Committees and Health Authorities. · Management of Investigational Product.

  • New Horizons
    • United States
    • Non-profit Organizations
    • 400 - 500 Employee
    • Instructor
      • Jan 2003 - Dec 2003

      -2003 · Taught the use of MS Windows, Word, Excel, PowerPoint, Access, Internet. -2003 · Taught the use of MS Windows, Word, Excel, PowerPoint, Access, Internet.

Education

  • Veterinarian Medicine, Universidad de
    1994 - 2001
  • Veterinarian Medicine, Universidad de Chile
  • Universidad de Chile
    1993 - 1999
  • Universidad de Chile
    Médico Veterinario, Agropecuarias
    1993 - 1999

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