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CRA II or Senior CRA (home based or office based)

Covance 3/6/2019 12:42:21 PM
JOB ID: 27878 Category: Clinical Research Associates
Milan, Italy

   

 

Job Overview

CRA II or Senior CRA positions available to work within and international environment across different therapeutics areas and phases I, II and III. 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 (6 per month)
* The role can be home based or office based in Italy.
* Join a stable team of CRAs 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. 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

Education / Qualifications

* University/college degree or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure, medical or laboratory technology).
* Thorough knowledge of ICH guidelines, GCP and the clinical trial process
* Knowledge of the drug development process.
* Proficient computer skills with good working knowledge of a range of computer packages including Electronic CRF processes.
* Excellent verbal and written communication skills (local language and English)
* Valid Driver's License

Experience

3-4 years of Experience in a related field, including 2-3 years of independent on-site monitoring in CRO or Pharma

Experience with all trial Phases I-IV and PoC Studies

Preferred Locations Rome and Milan


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).