Experienced Clinical Research Associate

13 ago - Roma
Altro

Our clinical activities are growing rapidly, and we are currently seeking full-time, home or office-based Clinical Research Associates to join our Clinical Monitoring team in Italy. This position will work with a team to accomplish tasks and projects that are instrumental to the company's success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.
Medpace will provide comprehensive initial and ongoing training depending on your previous experience.
Responsibilities Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol;
Communication with the medical site staff including coordinators, clinical research physicians, and their site staff;
Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors,



ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements;
Verification that the investigator is enrolling only eligible subjects;
Regulatory document review;
Medical device and/or investigational product/drug accountability and inventory;
Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
Assess the clinical research site's patient recruitment and retention success and offering suggestions for improvement; and
Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
Qualifications Master degree in health-related field

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