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CRA II or Senior CRA - Sponsor Dedicated (home based or office based)

Covance 1/11/2019 8:10:58 AM
JOB ID: 25533 Category: Clinical Research Associates
Milan, Italy

   

 

Job Overview

Discover new opportunities to grow your career as a Covance FSP CRA

CRA II or Senior CRA position available to work directly with a top 5 BioPharmaceutical company . As an Experience d 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.

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 requirement

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


Position Type: Full-Time

Location: Milan, ITA - Italy



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Covance Recruiting Process

Below is a general Overview of Our Recruiting Process

If you’d like to work for us, please submit your resume/CV online. If your ability to use or access our electronic application is limited due to a disability, please visit www.gettinghired.com or call 1-800-978-4473 for help.

We consider applications from everyone who is interested in a position with us and who meets the required criteria and qualifications.

If your application is selected, someone from our recruiting team will contact you to arrange an initial screen. We may carry this out over the phone or at a face-to-face meeting. You must complete the screen to be considered for the position.

Based on the results of the initial screen, we may invite you to an interview. One of our recruiting team members will contact you to arrange this. The process may involve several interviews, initially over the phone, and then face-to-face with different members of the hiring team.

Our interviews follow a behavioral-based format. This means we’ll ask you to give us information that’s specific to your professional and educational experiences.

Hiring team members will share and discuss their input and then make their decision.

If you’re the person who best meets the requirements of the position, a member of the hiring team will get in touch to make you an offer of employment. Covance is an eVerify employer (United States only).