Basic Requirements for Clinical Trial Nurses

There are several studies in countries in the Northern Hemisphere which have focused on the role of the research nurse within specialties. To date, there is no clear picture of the qualifications required to be employed as a CTN. Several findings indicate that there are varying pay rates for CTNs and a lack of consistency in the way they are employed. That is, some are employed according to nurses’ pay scales, and others are employed through the academic sector as administrative or research officers. This is confirmed in other studies in the UK. The Royal College of Nursing (RCN) in the UK has suggested appropriate clinical grades and salaries for these nurses as part of a competency framework which has been developed for future Clinical Research Nurses.

Competencies include the ability to show knowledge and understanding of the progression of clinical trials and to apply knowledge and skills in the clinical research environment. A Clinical Trial Nurse should work within and hold on to the requirements of clinical trial ethics, research governance and relevant legislation. It’s also very important to understand the principles and practice of obtaining valid informed consent from trial patients. However, these RCN standards were based on expert advice rather than empirical research. Further, the knowledge, skills and duties required by CTNs varies and can include: information technology skills; project management; protocol management; ability to develop; assess and direct research processes; clinical assessment of subjects; patient advocacy; education of patient and family about clinical research procedures and drug.

According to several clinical research associates the position of the CTN is very complex due to a combination of contractual and accountability arrangements. This position can be intensified by feelings of isolation, a lack of professional recognition and support and limited specific educational opportunities. Experienced CTNs are often highly skilled in terms of their specialist clinical knowledge, and have a comprehensive understanding of all aspects of the research process, including methodological, ethical and practical issues. Due to this increasing complexity of the role of the clinical research nurse, tertiary education programs for these nurses around the USA, UK, Canada and Europe are being conducted. A new Clinical Trials Research course was developed in Australia in 2012 in response to the need for formal clinical research qualifications and is offered at the postgraduate level (Master of Clinical Trials Practice, Sydney Nursing School) at the University of Sydney. Short courses are also available.

Several Institutes and Clinical Trials Network conducts programs and workshops for nurses working in clinical trials and some pharmaceutical companies and universities provide informal professional development on-the-job style education for these nurses. Thus the RCN profession looks very promising for the future.

For more in depth information about how to start a career in clinical research, please visit the Clinical Research Associate. Many CRAs start their career as a CTN, and this is a great way to get relevant experience.

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