Clinical Research Associate in Rome
21 ore fa
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 will work 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.
Responsibilities
Conducting site initiation and investigator training
Reviewing study case report forms (CRFs) completed by the investigative sites, and verifying entries by validating accurate source documentation to support CRF entries
Documenting site visits and issues in reports and follow-up letters to the site
Facilitating effective communications among investigative sites, the client and Meditrial
Identifying potential investigators in collaboration with the client
Responding to company, client and national regulatory requirements/audits
Contributing to the preparation of local forms and documents necessary for Study submission
Contributing to the project team by assisting in project communications
Qualifications
Higher or specialized secondary education degree in natural sciences
CRA Certification with monitoring visits are required
Familiar with electronic CRF and CTMS systems
Industry background: CRO/outsourced services, Pharmaceuticals, Biotechnology, Medical Device
Recent experience in medical device clinical trials
Fluency in English and Italian
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