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.
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.
