Experience

• 

  Recerca clínica

  Nov 2011 - Nov 2012

  Clinical research associate

  Several Clinical Trials Submissions to AEMPS (Spain Competent Authority) andCEICs (Spain Ethics Committees) Applications and approvals (CTA andAmendments)- Reporting of SAEs and SUSARs to AEMPS (Competent Authority) and CEIC(Ethics Committees)- Site Qualification Visits, Initiation visits, Monitoring visits, Close-Out Visits.- Contacts and correspondence to site staff, sponsors, ECs and CA.-Monitoring calls and teleconferences.- Protocol, Patient Information Sheet and Informed Consent Form review andadaptation to Local Regulations (and amendment management).- Participation on CRF design (paper CRF and eCRF) Show less

• 

  Icon plc

  Dec 2012 - Jan 2014

  Cra i
• 

  Orion clinical

  Jan 2014 - Nov 2015

  Cra ii
• 

  Keyrus biopharma

  Nov 2015 - Nov 2016

  Clinical trial coordinator

  • Management of Phase I to IV studies at an international level.• Setting up of the project procedures and guidelines.• Management of study specific budget, timelines and procedures compliance.• Creation and validation of the job specifications according to the sponsor’s requirements.• Preparation of invoicing of services to Sponsor.• Coordination of monitoring activities: training and follow- up of CRAs, CRAs management, compliance with the monitoring guidelines and the project team objectives, study metrics (KPIs) follow-up, review of monitoring reports.• Amendment of study documents e.g. protocol, CRF, informed consent forms, etc.• Coordination of submissions to regulatory authorities and follow up.• Reporting and communication with the sponsor.• Liaison between all departments involved i.e. clinical operations, regulatory affairs, biometry, safety, medical writing, finance.• Coordination of study partners e.g. providers, central laboratory, affiliates• Administrative follow-up of studies according to ICH-GCP.• Participating in the continual improvement of the Quality System e.g. Review and creation of internal SOPs, working instructions, monitoring templates, etc. Show less

• 

  Abbott (formerly st jude medical)

  Nov 2018 - now

  Position Summary: Assists in the planning and conduct of clinical studies. Ensures compliance to study protocol, domestic and international GCPs, applicable regulatory standards, and SOPs. Able to solve complex problems; considers alternative or new perspectives using existing tools and standard processes. Focus is on site management activities such as collection of essential documents, identifying and obtaining missing data, data corrections, reviewing and trending adverse events and protocol deviations. May contribute to developing study related materials; assists with writing reports and protocols. May also provide oversight of vendors and committees such as core labs and safety boards. Show less Position Summary: Responsible for the supervision of a team of CRAs. Assists the CRA Manager in hiring, training, developing and retaining qualified CRAs. Support the start-up, conduct and closure of Abbott clinical studies, working independently with minimal guidance and direction and ensuring compliance to study protocol, domestic and international Good Clinical Practices, applicable regulatory standards, and Abbott Standard Operating Procedures. Able to solve complex problems; consider alternative or new perspectives using existing tools and standard processes. Focus is on site management activities such as collection of essential documents, identifying and obtaining missing data, data corrections, reviewing and trending protocol deviations. Develop study related materials and may provide oversight of vendors and committees. Show less

  • Clinical Site Lead

    Jun 2020 - now

  • Senior CRA

    Jan 2017 - Jun 2020

  • Assistant CRA Manager

    Nov 2018 - Feb 2019