The clinical research industry is a rapidly growing field. One can't turn on the television or read the newspaper without hearing about the latest and greatest drug approved by the FDA. With this growth, come new and exciting job opportunities for the healthcare industry.
The clinical research industry has been responsible for bringing numerous careers to the forefront for healthcare professionals. One profession in particular, has been greatly impacted by this new growing enterprise; nurses.
Particularly, nurses involved in direct patient care are taking the opportunity to transition from standard clinical care to roles within the clinical research industry, especially given the demands on nurses have become greater due to nursing shortages and numerous healthcare policy changes.
The clinical research coordinator role has become a popular and sought after career alternative for nurses. Clinical research coordinators serve to aid in the coordination, management and conduct of clinical research under the supervision of a designated physician/investigator. Despite the interest and eagerness of nurses to leap into this alternative career, it is not always an easy transition. At least two major obstacles are often hurdled by nurses; 1) lack of a clear, defined job position of the clinical research coordinator and 2) lack of education and training to perform the responsibilities in this new occupation.
A concrete, defined role for the clinical research coordinator is not well defined in the industry literature. In fact, the ICH GCP guidelines do not even include a definition for clinical research coordinator in the definitions section (although you will find the role of the investigator defined). In a study conducted by Spilsbury, et. al., 1 the roles, responsibilities and contributions of clinical research nurses were evaluated. Findings reported that the clinical research nurse's role can influence the quality of the research; however the scope of this role was poorly defined. Further, they analyzed the transition process from a clinical care nurse to a clinical research nurse's role through a nursing focus group, and found that the clinical research nurses reported lack of confidence, role conflict, challenges in gaining the cooperation of the global nursing staff, and difficulties maintaining motivation within their newly defined role.
The second hurdle facing nurses in this new role is lack of clear, defined responsibilities which can lead to confusion and misinterpretation. Further, nurses are often not familiar with or have not been exposed to the specific knowledge or background required to perform within the function of this position.
To help ease this career transition process and avoid many of the issues cited by Spilsbury and his colleagues, education and training is a key factor for a successful career transition. Without the proper training and education prior to and during this transition, nurses (and often the physicians supervising the research and their designated role) are unaware that among specific job requirements and responsibilities, there are also federal regulations which they must abide by in the conduct of clinical research. Further, they are often unaware that there are specific guidelines (Good Clinical Practice guidelines) which should be followed. Often, this inexperience results in a naïve but true noncompliance with the law. Often times, federal violations resulting from lack of education and training are found during FDA audits through the FDA's Bioresearch Monitoring Program.
Despite the importance and growing interest in the clinical research coordinator role we continue to face challenges and resistance in supporting education and training for clinical research coordinators. Bakker, et. al., 2 evaluated a group of oncology nurses and their perception of research. The study concluded that the respondents valued research and perceived a role for nurses in the clinical research industry, however they did not perceive that there is a strong administrative and collegial support for their involvement. Many nurses who transition into this role attempt to seek training and education from supervisors and senior management but are declined for various reasons.
Despite the importance to train and educate new clinical research coordinators, there is no standard requirement for training and education within the clinical research industry. As nurses undergo education, training and licensure to practice clinically, there is no standard requirement when they transition into the clinical research arena. Until the industry considers education and training a priority or it becomes a standard job prerequisite, coordinators will continue to struggle in their roles and unfortunately not have the ability to function to their full capacity.
In conclusion, the clinical research industry offers a unique and stimulating career transitions for nurses. Nurses considering this transition should first research the roles of the clinical research coordinator and seek education and training to fulfill this new occupation. In addition, other suggestions for support include: membership and involvement in professional clinical research organizations, peer focus groups and a mentoring system.
References:
Bakker DA, Trottier T, McChesney C, "Clinical Oncology Nurses' Perception of Research", Canadian Oncology Nursing Journal, 7 (3): 150-161 (1997)
Spilsbury K, Petherick E, Cullum N, Nelson A, Nixon J, Mason S, "The Role and Potential Contribution of Clinical Research Nurses of Clinical Research Nurses to Clinical Trials", Journal of Clinical Nursing, April 5 (2007
Copyright: Copyright © 2008 Lisa Mazurka
About the Author:| Lisa Mazurka is Founder and President of Clinical Research Consulting, Inc. http://www.eclinicalresearchconsulting.com, a full service clinical monitoring, project management, training, and educational service organization committed to raising standards within the pharmaceutical and biotechnology industries. Lisa is an avid clinical educator and has delivered hundreds of educational programs for hospitals, academia and biotech start-ups to leading pharmaceutical companies. She has also taught for the Boston University School of Medicine and The Massachusetts Biotechnology Council.
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