CRA Belgium (M/W)
You are you a Clinical Research Associate (CRA) based in Belgium that has independent trial site monitoring experience on onclogy studies and would like to experience working at a client site while remaining an employee of Covance?
Our Flexible Solutions Clinical Research Associates enjoy the best of both worlds, you are a permanent employee of a growing Clinical Research Organisation; Covance while developing your knowledge in a global pharmaceutical company. You will join an exceptional team and manage all aspects of study site monitoring according to Client SOP, GCP, and ICH guidelines, including pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files.
Your responsibilities include:
Study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
Site management as prescribed in the project plans
Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
Independently perform Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management
May support in organization of meetings and other tasks as instructed by supervisor
Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
Excellent understanding of Serious Adverse Event (SAE) reporting
Typically 2+ years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits).
Knowledge of the Belgium site and regulatory environment is beneficial
Previous experience monitoring Oncology clinical trials is preferred