Oscar Linares

Oscar Linares

Trainee

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location of Oscar LinaresMexico City, Mexico

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  • Timeline

  • About me

    CRA II at ICON plc

  • Education

    • Universidad Nacional Autónoma de México

      2018 - 2018
      Course Pharmacovigilance and Technovigilance
    • Universidad Nacional Autónoma de México

      2005 - 2010
      Bachelor of Science Biological and Pharmaceutical Chemistry
    • Universidad Nacional Autónoma de México

      2015 - 2015
      Course Monitoring of Clinical Trials
  • Experience

    • Bio-Rad Laboratories

      Jun 2008 - Jul 2009
      Trainee

      Responsible for the maintenance and preservation of the site bacterial culture collection, performing microbiological lab work related to the cryopreservation of bacterial strains according to Good Laboratory Practices.

    • Colegio Nacional de Químicos Farmacéuticos Biólogos México, A.C.

      Feb 2011 - Jul 2011
      Trainee

      Responsible for social networks update Facebook and Twitter, and for the Historical Library sorting.Member of the Staff on training events held by the association.

    • Fisher Clinical Services

      Jul 2011 - Mar 2016

      Provide support to the QA Department on SOPs management, metrics, process follow-up, filing and update of documents in order to ensure the compliance of the cGxPs (Manufacturing, Storage, Distribution, Clinical and Documentation ). -Responsible for the Quality inspection and release of incoming items as to quality and quantity against freight documents and CoAs. -Local administrator of the Learning Management System. -Training to staff on GMP/GCP and other quality subjects. -Participation during review, issue and training of local SOPs as per Global Quality Polices, Local Regulations and clients’ requirements. -Participation during client/internal audits, and regulatory inspections. Show less Local coordination of reception, distribution, returns and destruction of medicinal products/materials, as well as secondary packaging activities. Notifications to clients as required. Responsible for the operations area coordinating and monitoring sub-contractors activities at the facility (maintenance, calibration, IQ, OQ, PQ, pest control, cleaning). Coordination and review of inventory stock controls according to annual plan and sponsors requirements and supply of auxiliary ensuring stock availability. Show less

      • QA Associate

        Apr 2014 - Mar 2016
      • Logistic Support Associate

        Jul 2011 - Apr 2014
    • ICON plc

      Mar 2016 - Aug 2017
      Study Management Associate

      Provide administrative support in the execution of clinical trials in accordance with ICH-GCP and standard operating procedures.Data entry and data management of CTMS. Support vendor management: reconcile vendor reports.Document management including essential document filing and TMF reconciliation.

    • Instituto Nacional de Cancerología

      Aug 2019 - May 2021
      Clinical Research Coordinator

      My role involves: -Managing patient scheduling and follow-up.-Recording and verifying data in the CRF, resolve data queries. -Keeping study files and records.-Ensuring study supplies are properly inventoried, stored, and reordered as necessary.-Interacting with IRB, lab staff, clinic staff, pharmacy, other departments in the institution.-Assisting in preparation and submit of IRB documents. -Coordinating and participate in monitoring visits with sponsor.-Assuring all study tests, procedures and visits are done in acordance with protocol. -Assigning and dispensing IMP as needed under investigator's supervision. -Preparing and shipping biological samples to central laboratory. Show less

    • ICON plc

      May 2021 - now
      • Clinical Research Associate II

        Sept 2023 - now
      • Clinical Research Associate I

        May 2021 - Sept 2023
  • Licenses & Certifications

    • TECNICO COMO LABORATORISTA CLÍNICO

      Secretaría de Educación Pública
      Jan 2010
    • LICENCIATURA COMO QUÍMICO FARMACÉUTICO BIÓLOGO

      Secretaría de Educación Pública
      Jan 2013