Clinical Research Associate

Contract duration: 1 year/possible extensionTravel: 20% in EuropeWorkload: 100%The Clinical Research Associate will design, plan, coordinate, and conduct all activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics. Responsibilities:Ensuring studies are conducted and documented in accordance with the study protocol, standard operating procedures, good clinical practices and other applicable regulatory requirementsValidating product performance claimsSupplying data for critical Regulatory submissionsDefining the functional and clinical utility of investigational productsObtaining opinions and input regarding investigational products from laboratories or customers, who may be considered key opinion leadersThe CRA is responsible for adhering to the policies of the quality system and achieving quality objectives through daily actionsPerforming or coordinating aspects of clinical studies including site selection, study initiation, site monitoring, and study closeoutMaintaining communication with study investigators to ensure studies are completed in a timely fashion and ensuring that study objectives are metInterfacing with cross functional staff to support post launch activitiesReviewing cases with investigators to resolve discrepanciesEnsuring that studies adhere to FDA regulations and Good Clinical PracticesRequirements:Degree in science or relevant field, Medical technology degree preferred, but not required if R&D background is adequateWilling to travel 20% of the time in EuropeExperience in clinical research and working in laboratoryKnowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines)