Covance CRA II or Senior CRA - Sponsor Dedicated in Rome, Italy
CRA position available to work directly with a large Pharmaceutical company in the cutting edge area of Oncology. As an experienced CRA you’ll be involved in initiation, routine & close out visits concentrating on sites in Italy. Successful candidates will enjoy the benefits of working for a company that values a WORK / LIFE BALANCE!
Unlike some CRA roles you will not be pushed to satisfy unrealistic ‘monthly visit’ targets
Join a stable team of CRAs across Italy and benefit from outstanding training and development, both initially and throughout your career
Join a company where people tend to stay for 6-10 years rather than 1-3!
Join a genuinely friendly and supportive company where they allow individuals to take ownership of their own performance.
As a CRA you will manage all aspects of study site monitoring according to SOPs, GCP, and ICH guidelines, including pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files.
All aspects of site management as prescribed in the project plans
Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks
Negotiation of study budgets with potential investigators and collaboration with Covance legal department with statements of agreements
Serious Adverse Event (SAE) reporting, production of reports, narratives and follow up of SAEs.
Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Covance or client data management systems
This CRA II or Senior CRA role is a full time & permanent position employed through Covance.
Education / Qualifications
University or college degree, or certification in related allied health profession from an appropriately accredited institution (e.g. nursing licensure)
Valid Driver’s License B
Thorough knowledge of CGP-ICH and basic understanding of the regulatory requirements
At least 2 years of independent monitoring experience.
Ability to monitor Clinical study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
Previous experience in Phases II and III trials
Previous clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits) in Italy.
Fluency in English.
Job Number 2018-18327
Job Category Clinical Research Associate
Position Type Full-Time
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