ClinicalResearchAssociate

As a CRA you will have local responsibility for the delivery of the studies at allocated sites and you will be an active participant in the local study team(s). You will work in close collaboration with other CRAs and the Local Study Team/ Local Study Manager to ensure that study commitments are achieved in a timely and efficient manner. You will act as the main contact with the study site and have the responsibility for monitoring the study conduct to ensure proper delivery of the study. You will be responsible for the preparation, initiation, monitoring and closure of assigned sites in clinical studies, in compliance with internal 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. **The CRA will usually have these accountabilities:** * Contributes to the selection of potential investigators. * Trains, supports and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. * Proves 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. * 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 local study teams. * Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues. * 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 sp