Kelly Healthcare – Portugal, is recruiting a Clinical Research Associate, for a client in Belgium.
The position reports to the Head of Quality Assurance and Control unit.
The Clinical Research Associate is responsible for “on-site” quality control of clinical trials to ensure that a clinical trial is conducted, recorded and reported in accordance with the protocol, the principles of Good Clinical Practice (GCP) and the applicable regulatory requirements.
Main responsibilities:
• Perform on-site monitoring visits according to the monitoring plan and following our client Standard Operating procedures (SOPs) and ICH-GCP guidelines;
• Ensure and control sites’ compliance with study protocol and regulatory obligations;
• Address issues in a manner that is beneficial for the site and our client team;
• Report the findings of the “on-site” monitoring visits according our client Standards;
• Follow the sites’ findings until resolution, with the support of our client study team and Quality Assurance and Control unit;
• Perform site staff training whenever needed during the study conduct;
• Ensures close collaboration between all actors of clinical trial research, as a privilege link between investigational sites and the study team
Profile
• University degree or equivalent in Health Sciences;
• Practical knowledge of the conduct of clinical trials;
• Prior experience of at least 1 year in Clinical Research (as monitor, data manager, or research nurse);
• Experience in Oncology is an asset;
• Languages:
– English : excellent level is required (written & spoken)
– German: good level is required (written & spoken)
• Excellent organization and communication skills
• Proactive, dynamic
• Flexible attitude with respect to work assignments and new learning
• Ability to travel an average of 40% within European countries
• Available immediately
Our client offers a highly stimulating, professional & friendly atmosphere in an international environment, and an attractive employee benefit package.
If you believe you have the requested profile, please send your CV in English to www.kellyservices.pt ( http://kcnpt.jobseu.recruitadvantage.com/job/job_details.cfm?id=403552&from=direct )
31/07/2013