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;
Willing to travel 60-80% nationally;
Familiarity with Microsoft® Office;
CRA certification completed as per DMC 15 /11 / 2011;
Fluent in English and Italian language;
Strong communication and presentation skills a plus.