Ensure clinical research studies are conducted in accordance with the protocol , standard operating procedures , good clinical practice , and applicable regulatory requirements by engaging with assigned sites.
Maintaining oversight on site related activities throughout the life cycle of project performing site selection , start-up / regulatory , initiation , monitoring and close out visits plus maintaining appropriate documentation ;
Manage the relations with the clinical centers with ad hoc remote and on-site monitoring
Manage the progress of assigned studies by documenting regulatory submissions and approvals , contracts and payments with the center, recruitment and enrollment , Case Report Form (CRF) completion and submission, and data query generation and resolution .
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Mandatory CRA certification according to the DM 15 / 11 / 2011
Master’s Degree preferably in life science
Previous experience as CRA (both for interventional and observatory studies) with independent monitoring experience of (at least) 1,5 years
Proficiency in use of Microsoft Word, Excel and PowerPoint
Excellence knowledge of Italian and English (you’ll interact in an international context)
Excellent organizational and problem-solving skills
Ability to establish and maintain effective working relationships with coworkers, managers and clients and site personnel at assigned sites
Location : as a CRA you’ll have the possibility to manage your work as home based
Must be able to travel in accordance with company and project requirements
Good interpersonal skills demonstrated as proactive , enthusiastic , and independent thinker
We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us.
You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.
Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™
Job ID : R1070357