Collegian (2012) 19, 239—246 Available online at www.sciencedirect.com jo ur nal homep age: www.elsevier.com/locate/coll The role of clinical trial nurses: An Australian perspective Lesley Wilkes a,* , Debra Jackson b , Charmaine Miranda b , Roger Watson c a School of Nursing and Midwifery University of Western Sydney/Nepean, Blue Mountains Health District, Australia b Faculty of Nursing, Midwifery and Health, University of Technology Sydney, Australia c School of Nursing and Midwifery Sheffield University, Sheffield, United kingdom Received 21 January 2011; received in revised form 20 December 2011; accepted 26 February 2012 KEYWORDS Clinical trial nurses; Role delineation; Professional issues Summary Over the past two decades, the number of clinical trials conducted globally has increased thereby increasing demand for nurses working as Clinical Trial Nurses (CTNs), some- times known as Clinical Research Nurses. The role and professional issues for these nurses in Australia has not been empirically formulated. Sixty-seven clinical trial nurses were surveyed nationally using a modified version of the Clinical Trials Nursing Questionnaire (CTNQ). Find- ings revealed the complex CTN role can include the coordination of the trials on one or more sites. This involves all domains listed in the questionnaire from protocol development, ethics approval applications, recruitment and consenting of participants in trials, to administering or assisting with treatments within the bounds of their practice code and the evaluation of proto- cols. Professional issues documented were: being undervalued in the nursing workforce, having no formal educational preparation for the role and minimal recognition in publications ema- nating from research in which they were involved. These nurses bring their practice knowledge to benefit research outcomes that may contribute to improving patient/client care. © 2012 Royal College of Nursing, Australia. Published by Elsevier Australia (a division of Reed International Books Australia Pty Ltd). All rights reserved. Introduction Clinical trials have become the hallmark of evidence in cre- ating the knowledge base for a broad spectrum of illnesses and appropriate treatments (Di Giulio et al., 1996). Over the past two decades, the number of clinical trials con- ducted globally has increased thereby increasing demand for ∗ Corresponding author at: Nepean Hospital, P.O. Box 63, Penrith NSW 2751, Australia. Tel.: +61 02 4734 3181; fax: +61 02 4734 3181. E-mail address: l.wilkes@uws.edu.au (L. Wilkes). nurses working as Clinical Trial Nurses (CTNs)—–also known by various other titles including Clinical Research Nurses and Research Co-ordinators. CTNs can, potentially, influ- ence the quality of clinical trials but little is written about the scope and contribution of their role in clinical trials in Australia. Prior to the study reported here, one study on the work satisfaction and professional issues of research co- ordinators in intensive care units in Australia was conducted by Rickard, Roberts, Foote, and McGrail (2007). Further- more, in Australia, there is no industrial classification for these nurses, contributing further to their invisibility in the nursing workforce. This paper reports the results of a 1322-7696/$ — see front matter © 2012 Royal College of Nursing, Australia. Published by Elsevier Australia (a division of Reed International Books Australia Pty Ltd). All rights reserved. doi:10.1016/j.colegn.2012.02.005