Prague, Czech Republic
Job Overview :
Discover new opportunities to grow your career as a Covance FSP Clinical Research Associate.
Covance FSP are looking to hire a CRA in Czech republic. In this position you will be fully dedicated to our sponsor.
At Covance, you can redefine what is possible and discover your extraordinary potential within our Functional Service Provider team (FSP).
As a Covance employee dedicated to an FSP project you will bring your specialized discipline to a core team working directly with one sponsor.
Whether your specialization is in clinical monitoring, clinical project management, data management, biometrics or pharmacovigilance Covance has an FSP opportunity to match your area of expertise.
Each FSP offers a unique opportunity to be a part of the drug development cycle and see a product through to launch. We have multiple partnerships giving you the variety and the flexibility to stay with sponsors, try a new external secondment or work in house on Covance studies.
With the support of exceptional people and an energized purpose, you’ll be empowered to own your career journey with dedicated mentoring, training and personalized development planning.
Responsibilities include : All details 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 Education / Qualifications : Life Science degree preferred or similar qualification. Experience :
Previous experience in monitoring study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines Excellent understanding of Serious Adverse Event (SAE) reporting Ability to resolve project-related problems and prioritize workload for self and team You have previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits).
0 : :