Clinical Research Associate / Senior Clinical Research Associate

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7kweaz

Premier Research is looking for a Senior Clinical Research Associate / Clinical Research Associate II to join our Clinical Monitoring, Site Management and SSU team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. We 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. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines
Monitors (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations
Plans day to day activities for monitoring of a clinical study and sets priorities per site
Prepares for and conducts on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites as required by clinical monitoring plan
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
Undergraduate 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
Previous clinical research experience required, completion of CRA training program
At 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.
The required CRA certification, qualifications and training record as per the requirements of the Italian Decree.
Premier Research is more than a company - it's a community furthering research to improve the lives of patients in critical need. Our Values - We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care - mirror the determination, flexibility and trust that our team embodies. Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning.
Introduce yourself to our Talent Team and we will reach out if there is a role that aligns with your experience and interests.
Premier Research is a global clinical research, product development, and consulting company. We are dedicated to helping biotech, specialty pharma, and MedTech innovators transform life-changing ideas and breakthrough science into new medical treatments. Premier is a place where you can change lives, and feel rewarded and celebrated. And we care about each other, about our customer and partners, and, most importantly, about all the patients that we touch with our work.
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Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7kweaz