Covance

CRA II or Senior CRA (Sponsor Dedicated & home based)

Job Location(s) IT-Rome
Job Number
2017-16060
Job Category
Clinical Research Associate
Position Type
Full-Time

Job Overview

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 the Netherlands. 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 the Netherlands 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.

 

Duty Highlights:

 

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.

Responsibilities include:

 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

 

Other Information:

 

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

Experience

  • 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.
  • Oncology experience

 

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