.Clinical Research AssociateLocation: CDMX, MTY or GDLAvailability to travel to the USHybrid workThe 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.Typical AccountabilitiesContributes to the selection of potential investigators.In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.Trains, supports and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.Confirms that site staff have completed and documented the required trainings appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times.Actively participates in Local Study Team (LST) meetings.Contributes to National Investigators meetings, as applicable.Initiates, monitors and closes study sites in compliance with AZ Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST.Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.Updates CTMS and other systems with data from study sites as per required timelines.Manages study supplies (ISF, etc), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable.Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan.Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan.Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.Ensures data query resolution in a timely manner.Works with data management to ensure robust quality of the collected study data.Ensures accurate and timely reporting of Serious Adverse Events and their follow-ups