Covance

CRA All Levels Romania

RO-Bucharest | RO
Job Number
2017-15558
Job Category
Clinical Research Associate
Position Type
Full-Time

Job Overview

CRA All Levels Romania

Summary:
CRA positions available to work within our Phase II-IV Clinical Operations Teams, Early Clinical Development or through our CoSource division directly with pharmaceutical companies. As an experienced CRA you’ll be involved in initiation, routine & close out visits concentrating on sites in Romania. Successful candidates will enjoy the benefits of working for a company that values a WORK / LIFE BALANCE!

Requirements:
- Ability to monitor Clinical study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
- Excellent understanding of Serious Adverse Event reporting
- Previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits) in Romania.
- Fluency in both English and Romania

USPs of CRA role:
- Unlike some CRA roles you will not be pushed to satisfy unrealistic ‘monthly visit’ targets 
- Join a stable team of CRAs across Romania 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:
These roles are full time & permanent positions employed through Covance. 

Key words:
Clinical Research, CRA, Clinical Research Associate, GCP, Monitor, Monitoring, Senior Clinical Research Associate, CRA I, CRA II, CRA III, LCRA, Oncology, Field Based, Home Based, CRO, Pharmaceutical, Romania, Bucharest

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