Experienced Clinical Research Associate (Cra) Lazio

Experienced Clinical Research Associate (Cra)
Roma
Lazio, Lazio

Job Summary: 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; Communicate 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; Verify medical record and research source documentation 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; Verify that the investigator is enrolling only eligible subjects; Review regulatory documents; Accountability and inventory of medical devices and/or investigational products/drugs; Verify and review 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 offer suggestions for improvement; Complete monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance. Qualifications: Master's degree in a health-related field; Willingness to travel 60-80% nationally; Familiarity with Microsoft Office; CRA certification completed as per DMC 15 / 11 / 2011; Previous experience as a CRA; Fluency in English and Italian; Strong communication and presentation skills are a plus. Medpace Overview: Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ more than 5, 000 people across 40 countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30 years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks: Flexible work environment; Competitive compensation and benefits package; Competitive PTO packages; Structured career paths with opportunities for professional growth; Company-sponsored employee appreciation events; Employee health and wellness initiatives; Awards: Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023, and 2024. Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility. What to Expect Next: A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps. EO / AA Employer M / F / Disability / Vets J-18808-Ljbffr