Clinical Research Associate

**Location** Mexico City, Mexico City, Mexico**Job ID** R- **Date posted** 23/06/2025**CRA**Location: CDMXThe Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The CRA is responsible for the preparation, initiation, monitoring and closure of assigned sites in clinical studies, in compliance with AZ Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. A CRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with LSAD. CRAs might have different internal titles based on the experience level (CRA, Senior CRA). 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 or Executive Director, Regional Head).**Typical Accountabilities**- Assists in coordination and administration of clinical studies from the start-up to execution and closeout.- 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”.- Ensuresthat 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.- Assists in coordination and administration of clinical studies from the start-up to execution and closeout.- 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”.- Ensuresthat 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.- Ensures compliance with local, national and regional legislation, as applicable.- Additional country-specific tasks might be added depending on local needs.**Mandatory Requirement**- Degree in Health Sciences ( Offical Certificate)- 1 - 2 years of experience as CRA- Advanced English Level (Good knowledge of spoken and written English)- Visa B1/B2- Proven organizational and administrative skills- Valid driver's license- Previous administrative experience preferably in the medical/ life science field.- Computer proficiency.**Desirable Requirement**- VEEVA- English level certification**Date Posted**24-jun-2025**Closing Date**13-jul-2025