CSA

The 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

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 Systems

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 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

• High school/Secondary school qualifications (*), that supports skills and capabilities of the position

and ensures successful conduct of responsibilities

and appropriate interactions with internal and or external customers.

• Previous administrative experience preferably in the medical/ life science field.
• Proven organizational and administrative skills.

• Computer proficiency.
• Good knowledge of spoken and written English.