pPremier Research is looking for a Senior Clinical Research Associate / Clinical Research Associate II to join our Clinical Monitoring, Site Management and SSU team. /p /brpYou will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. p /brul /brliWe are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. /li /brliAs an essential part of our team, you help us deliver the medical innovation that patients are desperate for. /li /br /ul /brpJoin us and build your future here. /p /brh3What You'll Be Doing /h3 /brul /brliDelivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines /li /brliMaintains submission of expenses according to travel and expense requirements within company guidelines /li /brliMonitors (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations /li /brliPlans day to day activities for monitoring of a clinical study and sets priorities per site /li /brliPrepares for and conducts on-site qualification, study initiation,



interim monitoring and close-out monitoring visits at investigator sites as required by clinical monitoring plan /li /brliMaintains Trial Master File (TMF)/electronic Trial Master File (eTMF) as defined by the organization’s processes per filing guidelines. Has an understanding of the required essential documents according to ICH/GCP Section 8. Reviews site documents and verify they are accurate, complete, current, and include required updates /li /br /ul /brh3What We Are Searching For /h3 /brul /brliUndergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., or equivalent work experience required /li /brliPrevious clinical research experience required, completion of CRA training program /li /brliAt least 4+ years’ experience in clinical trials to qualify for a Senior CRA level and at least 2+ years' experience in clinical trials to qualify for a CRA II level. /li /brliThe required CRA certification, qualifications and training record as per the requirements of the Italian Decree. /li /br /ul #J-18808-Ljbffr

📌 Senior Clinical Research Associate (Remote) (Italia)
🏢 Premier Research Group
📍 Italia