Información sobre: Beca Dpto Medico/ Site Management & Monitoring en Madrid

Empresa buscando Beca Dpto Medico/ Site Management & Monitoring

Madrid, España

Descripción de la invitación

Major Responsibilities:Assist in coordination and administration of clinical studies from the start-up to execution and close-out.Collect, assist in preparation, review and tracking of documents for the application process (HA/IEC). Interface with Investigators, external service provider and CRAs during the collection process to support effective delivery of a study and its documents. Serve as local administrative main contact and work closely with CRAs and/or the LSTL until finalization of the study.Support the Set-up of Trial Master File (eTMF) and ISF including tracking of documents. Maintain and close the local TMF (in electronic or paper form depending on study) ensuring International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) compliance and local requirements. Support the CRA in the maintenance and close out activities for the ISF.Contribute to the production and maintenance of study documents, ensuring template and version compliance.Know to how to Set-up, populate and accurately maintain information in AstraZeneca tracking and communication tools (e.g. IMPACT, SharePoint, Archivex, etc)Support the practical arrangements and contribute to the preparation of internal and external meetings e.g. study team meetings, monitor meetings, Investigator meetings. Liaise with internal and external participants and/or vendorsSupport additional country-specific tasks depending on country need.

Descripción del candidato

Skills and CompetenciesWorking knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/GCP guidelinesComputer skillsGood English knowledgeGood interpersonal skills and ability to work with other team membersIntegrity and high ethical standards