(Vienna, 9th of December 2011) Study assistants can now graduate from the MedUni Vienna with a university-accredited academic qualification. This is the first of its kind in Austria. “This training leads to a clear increase in quality assurance in the conduction of clinical studies," says Johannes Pleiner-Duxneuner, head of the coordination centre for clinical studies. Study assistants – also known as study nurses – act as an interface between the patients, investigators and sponsors of a clinical study.
The role of study nurses is based on Good Clinical Practice (GCP) and national legislation (e.g. Medicines Directive). Their area of responsibility lies primarily in the organisation and administration of clinical studies. They also take care of the support and aftercare of patients, the organisation of diagnostic material, sample dispatch, study medication and documentation. “Study nurses are, if you like, the investigator’s right-hand (wo)men,” explains Johannes Pleiner-Duxneuner, head of the coordination centre for clinical studies at the MedUni Vienna.
Clear competitive advantage
The university course, which lasts two years, prepares its students for this role with practical exercises, comprehensive teaching, a 40-hour practical training period and a month of permanent internship. Says Pleiner-Duxneuner: “This training represents a real competitive advantage. This is because sponsors from the industry are increasingly awarding their orders to centres that use study nurses.”
As well as the title of “Accredited Qualified Clinical Study Assistant”, the graduates of the course also receive 60 credit points in the European Credit Transfer System (ECTS), which defines the comparability of academic achievements. Says Pleiner-Duxneuner: “This is the first step towards a ‘Masters’. This can then be ‘topped up' to a Master of Science qualification.”
All of the information about the “Clinical study assistant” course can be found at www.meduniwien.ac.at/kks