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 Austria. Successful candidates will enjoy the benefits of working for a company that values a WORK / LIFE BALANCE!
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 Austria
Fluency in English and German.
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 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.
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
This CRA II role is a full time & permanent position employed through Covance.
CRA II, CRA I, Clinical Research Associate, Oncology, Clinical Monitor, Immunotherapy, CRA II, Cancer Clinical trials, Senior CRA
Life Science Background
Training in GCP