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Clinical research associate (cra) - law 68/99 art. 18

Pontirolo Nuovo
Contratto a tempo indeterminato
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Pubblicato il 20 agosto
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Job Summary Our clinical activities are growing rapidly, and we are currently seeking a full-time Clinical Research Associate (Law 68/99 Art. 18) 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 are seeking an exciting career where you can utilize your previous expertise and develop further, this is the opportunity for you. Medpace will provide comprehensive initial and ongoing training based on your previous experience. Responsibilities Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol; Communicate with medical site staff including coordinators, clinical research physicians, and their team; Verify investigator qualifications, training, resources, facilities, laboratories, equipment, and staff; Verify medical records and source documentation against case report form data, inform site staff of entry errors, ensure good documentation practices, and communicate protocol deviations per SOPs, GCP, and regulatory requirements; Ensure investigator enrolls only eligible subjects; Review regulatory documents; Manage medical device and investigational product/drug accountability and inventory; Review adverse events, serious adverse events, concomitant medications, and illnesses to confirm accurate data reporting; Assess patient recruitment and retention success, offering suggestions for improvement; Complete monitoring reports and follow-up letters, summarizing findings, deviations, deficiencies, and recommended actions. Qualifications Master's degree in a health-related field; Willing to travel 60-80% nationally; Proficiency in Microsoft Office; CRA certification as per DMC 15/11/2011; Previous CRA experience; Fluent in English and Italian; Strong communication and presentation skills are a plus. Medpace Overview Medpace is a full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to biotech, pharma, and medical device industries. Our mission is to accelerate the development of safe and effective therapeutics through scientific and disciplined approaches. Headquartered in Cincinnati, Ohio, with over 5,000 employees across 40 countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. Our work over the past 30 years has positively impacted many patients and families across various diseases. Today’s work aims to improve future lives. Medpace Perks Flexible work environment; Competitive compensation and benefits; Generous PTO; Structured career growth opportunities; Employee appreciation events; Health and wellness initiatives. Awards Recognized by Forbes as one of America's Most Successful Midsize Companies (2021-2024); Multiple CRO Leadership Awards from Life Science Leader magazine. What to Expect Next A Medpace team member will review your application, and if interested, you will be contacted with next steps. EO/AA Employer M/F/Disability/Vets J-18808-Ljbffr J-18808-Ljbffr

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