Oferta de empleo

Puesto Clinical Trial Assistant - CTA
Descripción de la oferta The Clinical Trial Assistant is part of the Clinical Operations and will work, when delegated, as a member of the study team with the responsibility to organize and maintain the Trial Master File (TMF) and coordinate practical tasks during the study according to company policies, SOPs and regulatory requirements.
Will be in charge of submission tasks, with Ethics Committees, Health authority and Autonomous Communities if required. As well will be responsible to manage site contracts, payments and addendums

•Work with the Study Team in initiating, maintaining and closing/final archiving of the TMF, ensuring GCP compliance
•TMF completion and preparation of shipment to sponsor as directed by the CPL/Lead CRA /CRA
•Production of documents, ensuring template compliance (final – applicable version, reproduction and distribution)
•Set up and maintenance of study information in electronic files as per delegation from CPL/Lead CRA/ CRA
•Point of contact regarding TMF
•Maintain the TMF as directed by the Lead CRA
•Set up the Investigator’s File as directed by the CRA
•Coordinate study supplies as directed by the CRA
•Assist in status reporting
•Arrange internal and external meetings
•Actively taking part in Study Team meetings and be responsible for the minutes
•Prepare, contribute to and distribute presentation material for meetings and newsletter
•Assist in activities associated with audits and regulatory inspections
•Actively contribute to the organization and development of routines to enhance the work at Alpha Bioresearch
Localidad Madrid / Bercelona
Requisitos
Estudios Diplomado
Idioma Inglés nivel Alto.
Experiencia Laboral 2 años
Disponibilidad Geográfica
Detalles de Contrato
Datos de la Empresa Alpha Bioresearch S.L.
Observaciones
OFERTA CADUCADA