Full-Time Clinical Research Associate
Job Description
Our mission – bringing medical miracles to market sooner – impacts the lives of millions of people all over the world. Our current growth of Clinical Development Services (CDS) in Eastern European countries brings new opportunities not only for clinical roles, but also another business functions.
CoSource, our insourcing division provides you with the opportunity to work directly for our clients. For these roles you will either work out of our client offices or field based – and see clinical trials from the clients’ perspective. We work in partnership with global and smaller pharmaceutical companies and can support you in your career development.
At the moment we are looking for: Clinical Research Associate 2 / Senior
As CRA 2 you will be responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits.
Responsibilities:
– Site administrating and site monitoring responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP;
– Recruiting potential investigators, preparing EC submissions, translating study-related documentation, organizing of meetings and other tasks as instructed by supervisor;
– Completing Serious Adverse Event (SAE) reporting, processing production of reports;
– Negotiating study budgets with potential investigators and assisting the Covance legal department with statements of agreements as assigned;
– Assisting with training, mentoring, and development of new employees, e.g. co-monitoring.
Required skills, Experience :
– Basic understanding of the clinical trial process
– Minimum two years of relevant clinical research Experience in pharmaceutical or CRO industries
– Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements.
– Thorough knowledge of monitoring procedures.
Required education:
– University Degree (life science) or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology);
– Fluency in Hungarian;
– Very good knowledge English language.
How to Apply
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