Clinical Research Associate for Diagnostics

July 24, 2012 by
Filed under: Clinical Research 

On behalf of our customer, a global player in the diagnostic market, we are looking for an individual with a background in clinical chemistry or diagnostic laboratory and experience in the clinical validation of test systems or reagents mainly used in Coagulation:



Clinical Research Associate for Diagnostics


The Global Clinical Operations Team is initiating and managing international clinical trials of devices and reagents used in clinical (professional) diagnostics. The CRA (Clinical Research Associate) assists one Global Study Manager in planning, coordinating and conduction of external validation activities for new systems (software and reagents) mainly used in Coagulation diagnostics.


Further responsibilities:


  • You are responsible for external validations within assigned projects and products
  • You are responsible for training of the sites, study monitoring, statistical calculations and interpretations, complaint handling and study close out
  • You organize all required activities and tasks in co-operation with other clinical trial departments
  • You ensure that all essential documents (IRB approvals, contracts, study protocols) are collected and filed in electronic and paper format, as appropriate
  • You are responsible for project tracking and ensure compliance of legal and regulatory requirements at the involved evaluation sites
  • You support design and preparation of study relevant documents e.g. test instructions and report forms
  • You participate in project teams to assess development of new projects regarding customer usability and practicability


Experience/Qualifications required:


  • You have an education as a medical laboratory technician with professional experience or BSc in Natural Science with experience in diagnostics
  • You have knowledge of processes within IVD laboratories: automation systems and workflow; knowledge in Coagulation diagnostics would be of asset.
  • You have professional communication skills and are able to communicate in English; knowledge of German is an asset
  • You are willing to travel within Europe up to 20% to give trainings to customers in clinical diagnostics
  • You are a proficient user of Office programs (Word, Excel, PowerPoint)



Are you interested in this career opportunity and like the prospect for professional and personal development? Are you available within the next 1-2 months? Please apply online today!

This position is a contract position for 1.5 years with the possibility for a permanent employment.


For any further information please contact Manuela Caligiuri,  Scientific Consultant at Kelly Scientific Resources Milan, phone:  email: or .


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