For our client is an innovative international pharmaceutical company that continually provides new drugs to patients around the world, we are looking for:
Clinical Research Associate
Work place: Kraków
At the moment we are looking for several Clinical Research Associates. Our Client has new roles open in Early Clinical Development team, as well as Clinical Operations and CoSource (outsourcing) teams.
As CRA 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.
Job Details:
- Site administrating and site monitoring responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP;
- Recruiting potential investigators, working with start-up department for 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.
About You:
- 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 local and English language.
- Understanding of the clinical trial process;
- Minimum 1 year of monitoring 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.
