Senior Clinical Research Associate

2 giorni fa

Smart working, Italia Premier Research Group Tempo pieno

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. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. /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 /brliYour ideas influence the way we work, and your voice matters here. /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., registered nurse); 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