Clinical Study Administrator The Clinical Study Administrator (CSA) plays a crucial role in the coordination and administration of study activities from start-up to execution and close-out.
Working within the Local Study Team (LST), the CSA ensures the quality and consistency of interventional study deliverables, meeting time, cost, and quality objectives.
Accountabilities Assists in coordination and administration of clinical studies from the start-up to execution and close-out.
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 LSM 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.
Enterprise Regulatory Vault) 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 Veeva Clinical Vault, SharePoint, etc.)
and supports others in the usage of these systems.
Prepares and/or supports contract preparation at a site level.
Prepares/supports/performs Health Care Organisations (HCO)/Health Care Professionals (HCP) payments in accordance with local regulations.
Manages and contributes to coordination and tracking of study materials and equipment.
Coordinates administrative tasks during the study process, audits, and regulatory inspections according to company policies and SOPs.
Leads the practical arrangements and contributes to the preparation of internal and external meetings e.g.
study team meetings, Monitors' meetings, Investigators' meetings.
Liaises with internal and external participants and/or vendors, in line with international and local codes.
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