Preparar, revisar y coordinar las presentaciones regulatorias locales: AEMPS, CE, aplicaciones locales nacionales especiales adicionales (aprobaciones de terapia génica, expedientes de seguridad viral, licencia de importación) según la estrategia de presentación global. Proporcionar asesoramiento sobre estrategias regulatorias a los clientes internos. Proporcionar servicios de SIA locales específicos del proyecto y coordinación de estos proyectos. Contacto con investigadores para actividades relacionadas con la presentación. Contacto clave a nivel de país para presentaciones relacionadas con cuestiones éticas o normativas. Coordinar con los departamentos funcionales internos para garantizar varias actividades de puesta en marcha y activación de los centros. Trabajar con el/la(s) CRA (s) para preparar la revisión de cumplimiento. Desarrollar una hoja de información para el paciente / formulario de consentimiento informado específico del país. Ayudar con los presupuestos y las negociaciones con los centros. Apoyar la coordinación de actividades de viabilidad. Introducir y mantener la información del estado de las actividades de SIA en las bases de datos. Asegurar que los archivos del estudio del país local y los procesos de archivo estén preparados y se mantenga según las SOPs.

Manage all documents required by Ethics Committee for research projects, post-authorization studiesand clinical trials evaluation.- Clinical trials follow up: Safety follow up of all clinical trials conducted in the hospital: management and review ofSUSAR, DSUR, SUSAR Periodic Line Listings, DHPC and DIL, Plan of Risk Minimization sentby sponsor. Annual Report, Final report, serious non protocol fulfilment and other notifications review.- Support to the Secretary of Ethics Committee and back up: attend to Ethics Committee meetings andassist the members of the Committee, prepare Ethics Committee reports, prepare approval reports andsend them to the sponsor/CRO.- Assist sponsors or Investigators in technical questions regarding clinical trials/project researchsubmission, evaluation and follow up.- Contact with Spanish Health Authority (AEMPS) in the evaluation process according new Legislationfor Clinical Trials. Assist them in technical issues.- Participate in meetings with Spanish Health Authority (AEMPS) in the new procedures for new ClinicalTrial Spanish Legislation and Post-authorization studies. Participate in testing the European clinical trialsdatabase.- Management of technical issues of VHP procedure with clinical trials.- Back up of all administrative positions in the Support Unit of Ethics Committee.- Attending English emails and telephone calls of the department. And support to internationalCRO/Sponsors with the Spanish procedures in clinical trials.- Ethics Committee website update according new international and Spanish legislations.- Drafting and updating the Standard Operating Procedure for the Research Foundation and for HealthAuthorities for the Ethics Committee accreditation.- Collaboration with Teching and Learning Department of the Research Foundation regarding clinicaltrials and clinical research.

Study start up process (feasibilities, contract review, collect and submit study documentation, attending investigators meetings and site pre-start and start up visits). Patient recruitment and selection with investigators for defined protocols, enrolment and randomization by Interactive Voice Systems. Coordinate and conduct patient care visits and assure all procedures are conducted in compliance with study protocol. Ensure study protocol compliance and monitor Good Clinical Practice accomplishment. Coordinating and training hospital services and staff involved. Send imaging, lab tests and samples to promoter. Manage patient’ treatment resupply. Collect patient medical history information to record in Electronic or Paper Case Report Form. Queries resolution. Report Serious Adverse Events to promoter’ pharmacovigilance service. Investigator’ files maintenance. Attend monitor and auditor for study source documents review. Financial management. Close out visits.

Contact and training of spanish hospitals involved in Spanish Lung Cancer studies. Manage lab samples shipping and results. Data base design, data entry and issuing queries, collaboration in study statistics and results presentation to investigators. Writing of protocol and informed consent, newsletters. Design of Case Report Form.And study coordinator duties.