AstraZeneca
Csa / Asistente
Job Description
**Clinical Study Administrator**:
**Location: CDMX**
**Hybrid work - 3 office days**
- Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents.
- 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.
- 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., st...
**Location: CDMX**
**Hybrid work - 3 office days**
- Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents.
- 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.
- 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., st...