Covance

Clinical Research Associates Poland

Job Location(s) PL-Warsaw | PL
Job Number
2017-14261
Job Category
Clinical Research Associate
Position Type
Full-Time

Job Overview

CRA II / SCRA – ONCOLOGY

 

Summary:


CRA II position available to work directly through our CoSource/ CLinical Operations or Early Clinical Development divisions. As an experienced CRA you’ll be involved in initiation, routine & close out visits. Successful candidates will enjoy the benefits of working for a company that values a WORK / LIFE BALANCE!

Covance Poland is certified as “HR of the Highest Quality”, which confirms the highest standards of HR practices in our Company.

 

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



USPs of CRA II role:


- Unlike some CRA roles you will not be pushed to satisfy unrealistic ‘monthly visit’ targets
- Join a stable team of CRAs across 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.
- ONCOLOGY focused

Other Information:
This role is a full time & permanent position employed through Covance.

Key words:
CRA II, GCP, Clinical Research Associate, Oncology, Warsaw, Poland, Clinical Monitor, Immunotherapy, Cancer Clinical trials

Education / Qualifications

CRA II:
- Ability to monitor Clinical study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
- Excellent understanding of Serious Adverse Event reporting
- Fluency in English and Polish

Experience

- Previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits) in the Poland

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