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Exploring the role and perceived impact of clinical research nurses on pharmaceutical drug research and development

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TitleInfo
Title
Exploring the role and perceived impact of clinical research nurses on pharmaceutical drug research and development
Name (type = personal)
NamePart (type = family)
Keller
NamePart (type = given)
Rosemary
DisplayForm
Rosemary Keller
Role
RoleTerm (authority = RULIB)
author
Name (type = personal)
NamePart (type = family)
Lindgren
NamePart (type = given)
Teri
DisplayForm
Teri Lindgren
Affiliation
Advisory Committee
Role
RoleTerm (authority = RULIB)
chair
Name (type = personal)
NamePart (type = family)
Eller
NamePart (type = given)
Lucille
DisplayForm
Lucille Eller
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Advisory Committee
Role
RoleTerm (authority = RULIB)
internal member
Name (type = personal)
NamePart (type = family)
Lev
NamePart (type = given)
Elise
DisplayForm
Elise Lev
Affiliation
Advisory Committee
Role
RoleTerm (authority = RULIB)
internal member
Name (type = personal)
NamePart (type = family)
Gladson
NamePart (type = given)
Barbara
DisplayForm
Barbara Gladson
Affiliation
Advisory Committee
Role
RoleTerm (authority = RULIB)
outside member
Name (type = corporate)
NamePart
Rutgers University
Role
RoleTerm (authority = RULIB)
degree grantor
Name (type = corporate)
NamePart
Graduate School - Newark
Role
RoleTerm (authority = RULIB)
school
TypeOfResource
Text
Genre (authority = marcgt)
theses
OriginInfo
DateCreated (encoding = w3cdtf); (qualifier = exact)
2016
DateOther (qualifier = exact); (type = degree)
2016-01
CopyrightDate (encoding = w3cdtf); (qualifier = exact)
2016
Place
PlaceTerm (type = code)
xx
Language
LanguageTerm (authority = ISO639-2b); (type = code)
eng
Abstract (type = abstract)
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. 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.
Subject (authority = RUETD)
Topic
Nursing
RelatedItem (type = host)
TitleInfo
Title
Rutgers University Electronic Theses and Dissertations
Identifier (type = RULIB)
ETD
Identifier
ETD_6899
PhysicalDescription
Form (authority = gmd)
electronic resource
InternetMediaType
application/pdf
InternetMediaType
text/xml
Extent
1 online resource (xii, 199 p. : ill.)
Note (type = degree)
Ph.D.
Note (type = bibliography)
Includes bibliographical references
Subject (authority = ETD-LCSH)
Topic
Nursing--Research
Subject (authority = ETD-LCSH)
Topic
Drugs--Research
Note (type = statement of responsibility)
by Rosemary Keller
RelatedItem (type = host)
TitleInfo
Title
Graduate School - Newark Electronic Theses and Dissertations
Identifier (type = local)
rucore10002600001
Location
PhysicalLocation (authority = marcorg); (displayLabel = Rutgers, The State University of New Jersey)
NjNbRU
Identifier (type = doi)
doi:10.7282/T3930W88
Genre (authority = ExL-Esploro)
ETD doctoral
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Rights

RightsDeclaration (ID = rulibRdec0006)
The author owns the copyright to this work.
RightsHolder (type = personal)
Name
FamilyName
Keller
GivenName
Rosemary
Role
Copyright Holder
RightsEvent
Type
Permission or license
DateTime (encoding = w3cdtf); (qualifier = exact); (point = start)
2015-12-07 22:28:45
AssociatedEntity
Name
Rosemary Keller
Role
Copyright holder
Affiliation
Rutgers University. Graduate School - Newark
AssociatedObject
Type
License
Name
Author Agreement License
Detail
I hereby grant to the Rutgers University Libraries and to my school the non-exclusive right to archive, reproduce and distribute my thesis or dissertation, in whole or in part, and/or my abstract, in whole or in part, in and from an electronic format, subject to the release date subsequently stipulated in this submittal form and approved by my school. I represent and stipulate that the thesis or dissertation and its abstract are my original work, that they do not infringe or violate any rights of others, and that I make these grants as the sole owner of the rights to my thesis or dissertation and its abstract. I represent that I have obtained written permissions, when necessary, from the owner(s) of each third party copyrighted matter to be included in my thesis or dissertation and will supply copies of such upon request by my school. I acknowledge that RU ETD and my school will not distribute my thesis or dissertation or its abstract if, in their reasonable judgment, they believe all such rights have not been secured. I acknowledge that I retain ownership rights to the copyright of my work. I also retain the right to use all or part of this thesis or dissertation in future works, such as articles or books.
RightsEvent
DateTime (encoding = w3cdtf); (qualifier = exact); (point = start)
2016-01-31
DateTime (encoding = w3cdtf); (qualifier = exact); (point = end)
2017-01-30
Type
Embargo
Detail
Access to this PDF has been restricted at the author's request. It will be publicly available after January 30th, 2017.
Copyright
Status
Copyright protected
Availability
Status
Open
Reason
Permission or license
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Technical

RULTechMD (ID = TECHNICAL1)
ContentModel
ETD
OperatingSystem (VERSION = 5.1)
windows xp
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