Yolanda Rodríguez Email and Phone Number

Responsible for management and follow up of Observational Registries and Clinical Trials in accordance to ICH Guidelines GCP and Local Laws. Trial Master file assembling, quality controls and audits maintenance and preparation. Communication with Ethic Committees, Health Authorities, investigator sites by e-mail and telephone.

Scientific journals publications, abstract, communications to international congresses.Support, development and follow up of Clinical Trials phase IV.

- Preparing and supporting followed-up, initiation, monitoring and close-out visits. - Monitoring reports and follow up letters.- Maintenance of TMF, IF an LAF.- Management of study medication.- Follow up of Serious Adverse Events (SAEs).- Communication with Ethic Committees, Health Authorities, investigator sites by e-mail and telephone. - Collaborating with CTA/LTM in feasibilities, submission of trial and preparing documentation for the submission of relevant amendments to the IEC.- Training in GCPs, Notification of Serious Adverse Events, FDA, ICF, IFDF...- International clinical trials, phase III. Infectious disease area.