Clinical Research Associate in Rome

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