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Exploring the Role and Perceived Impact of Clinical Research Nurses on Pharmaceutical Drug Research and Development By Exploring the Role and Perceived Impact of Clinical Research Nurses on Pharmaceutical Drug Research and Development by Rosemary Keller A Dissertation submitted to the Graduate School-Newark Rutgers, The State University of New Jersey in partial fulfillment of the requirements for the degree of Doctor of Philosophy Graduate Program in Nursing written under the direction of Teri Lindgren Ph.D., RN and approved by ___________________ ___________________ ___________________ Newark, New Jersey January, 2016 ©[2015] Rosemary Keller ALL RIGHTS RESERVED ABSTRACT OF THE DISSERTATION Exploring the Role and Perceived Impact of Clinical Research Nurses on Pharmaceutical Drug Research and Development By Rosemary Keller Dissertation Director: Dr. Teri Lindgren Many 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. ii 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. iii DEDICATION We have been created for greater things. Not just to be a number in the world. Not just to go for diplomas and degrees. This work and that work. We have been created in order to love and to be love. Mother Teresa I dedicate this dissertation to those whom I have loved dearly and who have shown great love to me during these last years as I pursued my doctorate. To my parents, William and Bridget Bennett, who showed me by example what true love is and instilled in me a love for life-long learning. To my sister, Dr. Anna Marie Tracy, who has been my rock. She has listened patiently and supported me through all life has given me. To my children who I love with all my heart. David who never ceases to amaze me with his intelligence, constant energy, and ability to work through any problem. To my daughter Kristin, who is my heart. She is the light of my world with her kindness and ability to give all she meets sunshine through any darkness. To my angel, Tom, he is the reason for this journey as he guides me daily through this life. To my Joe, who will always be my baby although he has graduated college and law school while I was still working on this degree. He is the best editor-in-chief and may now know more about clinical research after repeatedly reading this dissertation than any CRN. To TFox and Jess who let me know that love continues to grow. To my granddaughter, Madeline, who is the future of my world. To my husband, Dave, my love, my best friend, my partner, my constant support. It is with his love that together we have accomplished this goal. And lastly to God. It is through His grace that all good comes. iv ACKNOWLEDGEMENTS I would like to thank my Dissertation Chair, Dr. Teri Lindgren, for her continued support and guidance throughout my doctoral journey. Her input and counsel has been invaluable to this research. I would also like to thank my committee members, Dr. Lucille Eller and Dr. Elise Lev for their time, guidance and constant support for the past 10 years. I will always be grateful for your patience and understanding. I would also like to thank my committee member Dr. Barbara Gladson for her willingness to accompany me on this journey and lend her clinical research expertise to my dissertation. My sincere gratitude to the study participants who willingly gave of their time and shared their stories to give voice to this non-traditional career choice for nurses. I am truly thankful for these fellow clinical research nurses. v Table of Contents ABSTRACT OF THE DISSERTATION ........................................................................................ ii DEDICATION ................................................................................................................................ iv ACKNOWLEDGEMENTS ............................................................................................................. v Table of Contents ............................................................................................................................ vi List of Tables .................................................................................................................................. xi List of Illustrations ......................................................................................................................... xii Chapter 1: Introduction and Problem ............................................................................................... 1 Introduction to the Problem ......................................................................................................... 1 Statement of the Problem ............................................................................................................. 5 Phenomenon of Concern .............................................................................................................. 7 Purpose of the Study .................................................................................................................... 9 Significance of the Study ............................................................................................................. 9 Summary .................................................................................................................................... 11 Chapter 2: Literature Review and Conceptual Framework ............................................................ 13 Background of the Phenomenon ................................................................................................ 15 Title of Clinical Research Nurse ............................................................................................ 16 CRN as a Nursing Specialty .................................................................................................. 18 vi Drug Research and Development .......................................................................................... 27 Review of Empirical Literature ................................................................................................. 35 Study Coordinator Role ......................................................................................................... 36 Roles of CRNs Other Than Study Coordinator ..................................................................... 47 Definition of terms ..................................................................................................................... 50 Conceptual Framework of Role Theory..................................................................................... 50 Summary of Literature Review .................................................................................................. 55 Research Question ..................................................................................................................... 56 Chapter 3: Methodology ................................................................................................................ 57 Research Design ........................................................................................................................ 57 Rationale for Methodology .................................................................................................... 60 Sample ....................................................................................................................................... 61 Sample Selection ...................................................................................................................
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