Clinical Research Associate In Rome

15 ore fa


Lazio, Italia Meditrial Europe Ltd. A tempo pieno

Meditrial is looking for a certified clinical research associate (CRA) experienced in clinical trial monitoring, EDC systems, Digital Health solutions and Data analysis.The resource will participate in the preparation and execution of Phase I-IV clinical trials, oversee the progress of clinical investigations by conducting site evaluation, initiation, and interim close out visits to sites.He / she will monitor clinical trials in accordance with Good Clinical Practices and procedures set forth by Meditrial and sponsors.He / she willwork closely with the Clinical Project Manager to ensure all monitoring activities are conducted according to study requirements.The resource will be involved in Trial management activities in close collaboration with the CTAs and under the supervision of the Clinical Project Manager.The CRA will be office-based in Rome and be available to travel for monitoring activities.ResponsibilitiesConducting site initiation and investigator trainingReviewing study case report forms (CRFs) completed by the investigative sites, and verifying entries by validating accurate source documentation to support CRF entriesDocumenting site visits and issues in reports and follow-up letters to the siteFacilitating effective communications among investigative sites, the client and MeditrialIdentifying potential investigators in collaboration with the clientResponding to company, client and national regulatory requirements / auditsContributing to the preparation of local forms and documents necessary for Study submissionContributing to the project team by assisting in project communicationsQualificationsHigher or specialized secondary education degree in natural sciencesCRA Certification with monitoring visits are requiredFamiliar with electronic CRF and CTMS systemsIndustry background: CRO / outsourced services, Pharmaceuticals, Biotechnology, Medical DeviceRecent experience in medical device clinical trialsFluency in English and ItalianIndustry background: CRO / outsourced services, Pharmaceuticals, Biotechnology, Medical Device#J-*****-Ljbffr



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