.Candidatura PreidentificadaShort role descriptionThe Clinical Study Administrator (CSA) assists in the coordination and administration of the study activities from the start up to execution and close out, and within the Local Study Team (LST) to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives.
CSAs might have different internal titles based on the experience level (CSA, Senior CSA).
The experience level depends on the years of experience, performance record, level of independence in the role, ability to take on additional tasks or tutor more junior colleagues.The Director, Country Head may assign this internal title after confirmation with Senior Director, Cluster Head / Executive Director, Regional Head.Typical AccountabilitiesAssists in coordination and administration of clinical studies from the start-up to execution and closeout.Collects, assists in preparation, reviews and tracks documents for the application process.
Assists in timely submission of proper application/documents to EC/IRB and, where appropriate to Regulatory Authorities for the duration of the study.Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents.Serves as local administrative main contact and works closely with the CRAs and/or the LSAD for the duration of the study.Operational responsibility for the correct set-up and maintenance of the local eTMF and ISF including document tracking in accordance with ICH-GCP and local requirements.Ensures essential documents under their responsibility are uploaded in a timely manner to maintain the eTMF "Inspection Readiness".Ensures that all study documents are ready for final archiving and completion of local part of the eTMF and supports the CRA in the close out activities for the ISF.Contributes to the production and maintenance of study documents, ensuring template and version compliance.Creates and/or imports clinical-regulatory documents into the Global Electronic Management System (e.G.
ANGEL) ensuring compliance with the AstraZeneca Authoring Guide for Regulatory Documents.Contributes to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.E., Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities.Sets-up, populates and accurately maintains information in AstraZeneca tracking and communication tools (e.G.
CTMS such as VCV, SharePoint, etc) and supports others in the usage of these systems (with the exception of countries where there is a specific role dedicated to set up and update the systems).Prepares and/or supports contract preparation at a site level (with the exception of countries where there is a specific role dedicated to preparing site contracts)