.Clinical Research AssociateLocation: CDMX/GDL/MTYHybrid work (3 office days)Primarily responsible for coordinating the various aspects of clinical trials. Works as part of a clinical delivery team providing support, guidance, and advice on a local level. Develops existing tools and processes to identify areas of improvement and ensures business continuity for study delivery. Able to solve complex problems within a range of studies.What you'll doThe Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated centres and is an active participant in the MC study team(s). The CRA works in close collaboration with other CRAs and the Local Study Delivery Team to ensure that quality and quantity commitments are achieved in a timely and efficient manner.The CRA is responsible for the preparation, initiation, monitoring, and closure of an agreed number of centres in clinical studies according to AZ Procedural Documents, international guidelines such as ICH and GCP, as well as relevant local regulations. Deliver according to the commitment in the individual trials.A CRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with Lead CRA, Senior CRA, or Local Study Team Leader (LSTL).Typical AccountabilitiesEnsures the processes for Study Delivery are executed through the development of study reports tools, facilitation of the study delivery system, and maintenance of the system.As an expert, ensures delivery of a centrally managed study management service across clinical studies from start-up to reporting.Serves as the main contact and works closely with the Document Management group until the Clinical Study Report is finalized.Initiates and maintains production of study documents, ensuring template and version compliance.Creates or imports clinical-regulatory documents into the Global Electronic Library according to the Global Document List.Interfaces with Data Management Centre or Data Management Enablement representatives to facilitate the delivery of study-related documents.Manages and coordinates tracking of study materials and equipment.Monitors administrative tasks during the study process, audits, and regulatory inspections according to company policies.Acts as a technical owner within Patient Safety with a deep understanding of processes and internal regulations.Keeps own knowledge of best practices and new relevant developments up to date.Liaises with compliance team members to improve regulatory processes within the team.Identifies opportunities to improve the methodology and provide practical solutions for clinical development.Essential for the roleBachelor's degree (with official recognition).Good knowledge of relevant local regulations.2+ years of experience in site monitoring.Good medical knowledge in relevant AZ Therapeutic Areas.Basic understanding of the drug development process
