Experience

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  Pontificia universidad católica de chile

  Jun 2004 - Feb 2006

  Associated investigator

  • Clinical research, vaccines development, Immunology, Molecular Biology• Oral vaccines research against “Helicobacter pylori” (FONDEF PROJECT).• Research CD4+ T cells induced in response to Neisseria gonorrhoeae antigens in murine model (FONDECYT PROJECT).

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  Sanofi-aventis

  Mar 2006 - Sept 2010

  .• Performed routine monitoring visits tasks: selection visits, initiation visits, periodic monitoring visits and closure visits according to sanofi-aventis SOPs.• Clinical Safety Officer Tasks: acting as primary local contact for Global Pharmacovigilance & Epidemiology (GPE) concerning pharmacovigilance activities to ensure compliance with international and local safety requirements additional to the guidelines and corporate procedures. In charge of serious adverse events (SAEs) reporting process, queries management, training to Monitoring Team (MT) according to sanofi-aventis SOPs. Management of SAE-tracking database. • In charge of training of new comers in Pharmacovigilance activities. Show less

  • Clinical Research Associate I & Clinical Safety Officer

    Jun 2008 - Sept 2010

  • Clinical Trial Application & Clinical Safety Officer Support

    Oct 2006 - May 2008

  • Clinical Project Assistant

    Mar 2006 - Oct 2006
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  Covance

  Oct 2010 - Jun 2015

  General on site monitoring responsibilities:-Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safety enter patients into the study;-Ensure protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements;-Ensure integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by carefully source document review;General on site monitoring responsibilities;Prepare accurate and timely trip reports;Responsible for Reviewing Trip Report for Latinamerica and comply with completion timelines;Review progress of projects and initiate appropriate actions to achieve target objectives;Interact with internal work groups to evaluate needs, resources and timelines;Undertake feasibility work when requested;Assist with training, mentoring, and development of new employees, e.g. co-monitoring;Responsible to escalate study regional findings to the study Project Management.EDC CERTIFICATIONS: Oracle Inform; Medidata RAVEIVRS/IWRS Experience: Almac, Phase Forward, S-Clinica Show less

  • Sr. Clinical Research Associate

    Mar 2014 - Jun 2015

  • Clinical Research Associate II

    Oct 2010 - Feb 2014
• 

  Bristol myers squibb

  Nov 2021 - Nov 2024

  - Identifies new potential Investigators, through ongoing collaborations with medical contacts. Assess potential Investigators and their sites. Documents the visit, and communicate findings. Provides feedback on Potential Site Assessment findings to collaborators.- Recommends sites for consideration in future studies, as needed.- Expedites the pre-study and study initiation processes including the conduct of Pre-Study Evaluation and Site Initiation visits. Conducts initiation visits in collaboration with Clinical Site Managers, Field Medical and/or Protocol Managers. Orients and trains site personnel regarding the protocol, study related processes and procedures and applicable regulatory requirements.- Reviews site activities and quality through on-site visits in addition to emote management capabilities. Monitors study sites following the monitoring plan, BMS SOPs, protocol, ICH/GCP Guidelines and other local regulations as applicable. This includes, but is not limited to: Managing multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory.- Ensures safety and protection of study subjects according to the monitoring plan, SOPs, and ICH/GCP Guidelines and local regulations. Ensures quality of data submitted from study sites and assures timely submission of data by using the available systems to follow site activities.- Motivates/influences site personnel to meet study objectives, including enrolment and retention goals. Resolves study site problems/issues as they occur. - Ensures documented follow-up to all outstanding issues/corrective actions in the available systems.- Uses multiple technologies to maintain open and frequent communication with all stakeholders.- Employs good fiscal management for travel expenses, etc. Show less

  • Clinical Trial Manager

    Jun 2023 - Nov 2024

  • Clinical Trial Monitor

    Jul 2015 - Nov 2024

  • Patient Safety Backup

    Nov 2021 - Mar 2023
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  Icon plc

  Dec 2024 - now

  Sr. cra

  Identify , select, initiate and close-out investigational sites for clinical studies.Monitor those sites to ensure studies are carried out according to study protocol, sponsor SOPs/WPs, applicable regulations and the principles of ICH-GCP.Ability to mentor, train and/or supervise other clinical staff as appropriate.