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Exploring the role and perceived impact of clinical research nurses on pharmaceutical drug research and development
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Keller, Rosemary. Exploring the role and perceived impact of clinical research nurses on pharmaceutical drug research and development. Retrieved from https://doi.org/doi:10.7282/T3930W88

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TitleExploring the role and perceived impact of clinical research nurses on pharmaceutical drug research and development
NameKeller, Rosemary (author); Lindgren, Teri (chair); Eller, Lucille (internal member); Lev, Elise (internal member); Gladson, Barbara (outside member); Rutgers University; Graduate School - Newark
Date Created2016
Other Date2016-01 (degree)
SubjectNursing, Nursing--Research, Drugs--Research
Extent1 online resource (xii, 199 p. : ill.)
DescriptionMany new drugs and treatments come to clinical practice as a result of the combined and coordinated efforts of skilled multidisciplinary team in the pharmaceutical drug research and development process. Although Clinical Research Nurses (CRNs) contribute to this process, the role of the CRN who works at many places along the continuum of pharmaceutical drug research and development has not been described from the CRN perspective. The purpose of this study was to explore and describe the role experiences and perceived impact of the CRN, other than a research study coordinator, who works within the pharmaceutical industry. A focused ethnography methodology was used to examine the ordinary conscious experience of the work life of the CRN and their views of this non-traditional nursing role. Rutgers University IRB approval was obtained prior to study initiation. Twenty-one participants whose roles included, drug safety and risk management, clinical trials, regulatory management, and data dissemination, were interviewed to discover their perspectives of working in a non-traditional nursing role within pharmaceutical drug research and development. Four main themes emerged from the data: Work environment, The goal of the role, Being in the role of clinical researcher and Being a nurse in the role of clinical researcher. The highly demanding, and changing work environment is based on a business rather than a clinical model. In this setting the CRNs’ role was not about direct patient care but about caring for the larger population, both research subjects and product consumers. The goal of the CRN role is to ensure the integrity of clinical research so that only safe and effective treatments reach the clinical setting. The roles that nurses enact are varied but all require multidisciplinary collaboration and communication. Nurses in this role put patients in the forefront and use their nursing knowledge, training, and professional judgement to ensure the safe and ethical conduct of clinical research. This study illustrates a unique role for nurses within the pharmaceutical industry to care for the public’s health. The changing business focused environment impacts their role but they use their nursing experience to advocate for study patients and patient consumers.
NotePh.D.
NoteIncludes bibliographical references
Noteby Rosemary Keller
Genretheses, ETD doctoral
Persistent URLhttps://doi.org/doi:10.7282/T3930W88
Languageeng
CollectionGraduate School - Newark Electronic Theses and Dissertations
Organization NameRutgers, The State University of New Jersey
RightsThe author owns the copyright to this work.
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