Journal of Research in Nursing

2022, Vol. 27(1-2) 50–65

Nurses in clinical trials: perceptions © The Author(s) 2022
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DOI: 10.1177/17449871211073757
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Carolynn T Jones 
Associate Professor, The Ohio State University, Columbus, OH, USA

Catherine A Griffith 
Clinical Research Nurse, Patient Care Services, Massachusetts General Hospital, Boston, MA, USA

Cheryl A Fisher 
Associate Professor, School of Nursing, Nursing Informatics, University of Maryland, Bethesda, MD, USA

Kathleen A Grinke
Clinical Research Nurse, Patient Care Services, Massachusetts General Hospital, Boston, MA, USA

Rosemary Keller
Clinician, Worldwide Research and Development/Safety, Pfizer, Inc., New York, NY, USA

Hyacinth Lee
Clinical Research Manager, ITHS Translational Research Unit, University of Washington, Seattle, WA, USA

Michelle Purdom
Vice President, Clinical Research and Operations, TG Therapeutics, Inc., New York, NY, USA

Elyce Turba 
Clinical Research Nurse, Malignant Hematology Department, Moffitt Cancer Center, Tampa, FL, USA

Abstract
Background: Clinical Research Nurses practice across a wide spectrum of roles and settings
within the global research enterprise. Clinical Research Nurses working with clinical trials face a
dual fidelity in their role, balancing integrity of the protocol and quality care for participants.
Aims: The purpose of this study was to describe Clinical Research Nurses’ experiences in clinical
trials, educational preparation, and career pathways, to gain a deeper understanding of clinical
research nursing contributions to the clinical research enterprise.

Corresponding author:
Carolynn T Jones, College of Nursing, The Ohio State University, 1585 Neil Avenue, Columbus, OH 43210, USA.
Email: [email protected]
Jones et al. 51

Methods: An internet-based survey was conducted to collect demographic data and free text
responses to four open-ended queries related to the experience of nurses working in clinical trials
research, educational preparation, and role pathways. Qualitative content analysis was used to
analyze free text responses. The study was guided by the Clinical Research Nursing Domain of
Practice and Duffy’s Quality Caring Model of relationship centered professional encounters.
Results: Forty clinical research nurses responded to the open-ended questions with themes
related to dual fidelity to study participants and protocols, relationships and nursing care, inter-
disciplinary team membership and contributing to science, emerging from the data. Gaps in ed-
ucational preparation and professional pathways were identified.
Conclusion: This study provides insights to unique clinical research nurse practice contributions in
the clinical trial research enterprise within a context of Duffy’s Quality Caring Model.

Keywords
clinical research nurses, clinical research nurses role delineation, clinical trials, educational
preparation, Quality Caring Model©, relationships, study coordinators

Introduction
Clinical Research Nursing is the specialized practice of professional nursing focused on maintaining
equilibrium between care of the research participant and fidelity to the research protocol (IACRN, 2012).
Although the need for clinical research nurses has surged to the forefront of public awareness during the
COVID-19 pandemic, this nursing specialty has been supporting critical research for decades. Chal-
lenges during the pandemic included managing the worldwide crisis, gathering clinical data, designing
treatments to mitigate or prevent acuity of the illness, and building a biorepository to understand
symptom management and vaccine development. Consequently, the research community, including
clinical research nurses, went into overdrive to develop lifesaving therapeutics and treatments. Hence,
the pandemic of COVID-19, with the associated need for rapid research and clinical trials, accentuated
the important contributions nurses specializing in Clinical Research Nursing make to public health.
Other challenges in clinical research include increasing complexity of clinical research studies and
challenging study populations (Getz & Campo, 2017).
An estimated 10,000 clinical research nurses (CRNs) are found working across a wide spectrum
of roles and settings within the global clinical research enterprise (American Nurses Association and
International Association of Clinical Research Nurses, 2016; Wallen and Fisher, 2018). Previous
role delineation studies on CRNs have primarily focused on nurses working in acute care, dedicated
research units, or clinic settings (Bevans et al., 2011; Castro et al., 2011; Ehrenberger and Lillington,
2004), yet many other professional settings exist. These settings include contract research orga-
nizations and biopharmaceutical companies where CRNs work as project managers, study monitors,
auditors, and directors. Nurses have also held positions as medical science liaisons, monitors, and
other professional roles within biotechnology or pharmaceutical company settings. Likewise, many
nurses have also worked in regulatory and government agencies, as Food and Drug Administration
(FDA) inspectors or commissioners and as project managers and clinical research educators in
federal institutes. These complex research settings create the environment in which the CRN
provides a critical linkage between the patient, family and the research team.
52 Journal of Research in Nursing 27(1-2)

Clinical research nurse domain of practice

A team from the National Institutes of Health (NIH), Clinical Center, Nursing Department, defined
the Clinical Research Nursing Domain of Practice (Figure 1) differentiating skillsets under five
categories: (1) Care Coordination and Continuity; (2) Clinical Practice; (3) Human Subjects
Protection, (4) Study Management, and (5) Contributing to the Science (CRN 2010 Domain of
Practice Committee, 2009). This work led to the formation of the International Association of
Clinical Research Nurses (IACRN), the development of the scopes and standards of practice for
clinical research nurses, and the acceptance of the CRN specialty practice by the American Nurses
Association (American Nurses Association and International Association of Clinical Research
Nurses, 2016). Henceforth, research has been conducted on nursing roles in oncology (Purdom
et al., 2017); nurses perceptions of their value to clinical research protocols and participant care
(McCabe et al., 2019); and issues in isolation from other nurse colleagues, and stress in dichot-
omizing patient advocacy and protocol adherence (Hernon et al., 2020).
The setting for clinical trials research is multi-dimensional and includes broader interdisciplinary
relationships and responsibilities with patients, clinical research teammates, investigators, other
interdisciplinary teams, laboratories, ethical boards, research sponsors, and monitors. Moreover,
CRNs are often responsible for multiple simultaneous and overlapping clinical trials (Gwede et al.,
2005). Within the context of operationalizing clinical trials, CRNs consider the study participants
(and their families) as their patient populations. Balancing clinical care, the clinical trial protocol
boundaries, regulations, and bioethics, CRNs are dedicated to excellence in patient care and fidelity
to the research. Though not working in the traditional clinic or bedside setting, CRNs very much
identify as a nurse and feel strongly about their contributions to the care of participants and to
innovative discoveries that prevent, treat, cure, or mitigate diseases.

Figure 1. Clinical research nursing domain of practice.

Jones et al. 53

Theoretical context
The CRN role in clinical trials operations and patient management fits naturally with the Quality
Caring Model©, a theory developed by Joanne Duffy that was used to better understand nursing
roles in terms of an evidence-based practice and nursing’s unique contributions (Duffy and Hoskins,
2003). The Quality Caring Model© comprises two types of caring relationships: independent
relationships (nurse to patient/family; discipline-specific interventions), and collaborative rela-
tionships (nurse to other members of healthcare team; activities and responsibilities) (Figure 2).
Similar to the role of nurses as described by Duffy, the focus of the CRN is on the patient from a
clinical trial participant perspective and on the collaborative relationships with the research team in
conducting the research.
This research focused on the role of CRNs working in clinical trials of investigational new drugs
and devices. The purpose of this study was to explore the CRNs’ perceptions of their unique
contributions to clinical trials research, their educational preparation, and progression pathways for
their roles by telling their stories.

Methods
Sample and data collection
An online survey was conducted to explore nurses’ written descriptions of working and supporting
clinical research utilized Qualtricsxm (Qualtrics, Provo, UT, version 9, www.qualtrics.com) internet-
based survey platform. The survey tool was piloted with two volunteer participants to improve
quality. Participants were invited via email through the International Association of Clinical
Research Nurses (IACRN) membership listserv (approximately 360 members), and via social media
(e.g., LinkedIn, and Twitter). A study flier, including a URL and QR code inserted in both email and

Figure 2. Duffy’s Quality Caring Model.

Source: Quality Caring Model©
54 Journal of Research in Nursing 27(1-2)

social media invitations were accessible via computer and mobile technology. Members of the
research team also informally shared the survey flier to CRN colleagues. Responses were anonymous.
The first “question” of the survey was the informed consent form. By clicking “Yes,” participants were
automatically advanced to Question two and the remainder of the survey or exited if “No” was clicked.
The survey properties allowed participants to complete the survey in one sitting or to leave the survey at
any time and return to it, picking up where they left off. The survey was launched during the Summer of
2019. The snowball approach precluded an ability to estimate an accurate denominator.

Participants
The survey was aimed at nurses working in clinical trials research. The two participation criteria
were:

1. Licensed (Registered) Nurse (RN) whose role was to support clinical trials research with at
least 2 years of experience in the clinical research nurse role, and
2. Willing and able to answer the qualitative questions in written English.

The authors were excluded from survey participation.

Data collection
The survey included a demographic section (12 objective questions), followed by four open-ended
queries where participants were invited to share their “stories” as nurses working in support of
clinical trials research and their educational preparation and role progression, via free text input
(Table 1).
We allowed 15,000 characters for each open-ended item (equivalent to 4.5 single-spaced pages each).

Data analyses
Descriptive statistics were used to organize and describe the characteristics of the survey re-
spondents. Researchers used inductive content analysis to analyze participant open-ended written
responses and identify themes or patterns (Hseih and Shannon, 2005). Working in pairs, two
members of the study team used NVivo (QSR International, Pty Ltd, Version 12, 2018) and MS
Excel® (Microsoft Corporation, MS Office, Version 2016) for initial independent coding of written
participant responses. In a second review, the team sought to compare concurrence for common
themes. A third review was conducted to determine thematic level of meaning units, and consolidate
categories that were similar. The qualitative data were also circulated to additional team members to
determine final consensus of meanings and themes.

Table 1. Open-ended survey queries.

Queries about the CRN role Queries about education and role progression

1. Please tell us what being a nurse who supports clinical 1. Please tell us your feelings about your educational
trials research means to you preparation for your clinical research roles as a nurse
2. Please tell us one story about a unique experience you 2. Please describe your career progression from your first
have had as a nurse in a clinical trials research role clinical research position as a nurse, to today
Jones et al. 55

Findings
We expected a response rate of 50; however, we had an enthusiastic response of 100 respondents. Of
those, 97 met entry criteria. The majority of respondents were female (90%). The sample consisted
of individuals who were highly experienced in clinical trials research, the majority of whom (30%)
had greater than 20 years of clinical trials experience, followed by 23% having 6–10 years of
experience (Figure 3).
Respondents listed broad ranges of job titles. Of the 90 reported job titles, there were 65 unique
titles. Similar titles were grouped together to facilitate role categories (Table 2). The most
frequently reported title was Research Nurse/Clinical Research Nurse 30 (33.3%). Titles grouped
as “Other” (7.8%) included: Biostatistician, Clinical Nurse Specialist, Clinical Research As-
sociate, Coverage Analyst, Medical Data Review Manager, Protocol Interpreter, and Rural Nurse
Specialist.
Participants worked in a variety of work settings (Figure 4), with most (52%) working in
outpatient settings at academic medical centers (AMCs), followed by AMC inpatient (15%)
(Figure 4). One indicated that they worked for the NHS Foundation Trust (United Kingdom) and
another at a College of Nursing. No participants worked at US regulatory authorities (e.g., FDA) or
non-clinical government agencies.
Most respondents worked in the United States (84%) followed by UK (6%) and Ireland (4%). We
also had a respondent from India and New Zealand. Those working in the United States lived
primarily in the Northeast and Southeast with a decreasing frequency from the Midwest, West, and
Southwest.

Clinical Research Nurse perception of role of the nurse in clinical trials

Themes that emerged from the data in response to the two open-ended questions, “Please tell us
what being a nurse who supports clinical trials research means to you” and “Please tell us one story

Figure 3. Years of experience working in clinical trials.

56 Journal of Research in Nursing 27(1-2)

Table 2. Frequency of job title categories.

Job title category Frequency %

Research nurse/clinical research nurse 30 33.3

Research program manager/coordinator 19 21.1
Clinical research nurse coordinator 14 15.6
Project management 8 8.9
Other 7 7.8
Quality assurance 4 4.4
Research consultant 3 3.3
Research nurse practitioner 3 3.3
Research education nurse 2 2.2
Grand total 90 100

Figure 4. Work settings of clinical trial nurse respondents.

Note: CRO = contract research organization; pharma/biotech = pharmaceutical or biotechnology companies; AMC=
academic medical center; inpt = inpatient; outpt = outpatient.

about a unique experience you have had as a nurse in a clinical trials research role” included (1)
dual fidelity in the role, (2) unique contribution to research enterprise, and (3) impact on patients
through relationships.
Forty-six respondents described that being a clinical research nurse conducting clinical trials
means having opportunities to contribute to the clinical research enterprise and to new scientific
advances through knowledge of the research process and nursing expertise in care of clinical
research participants. They expressed their role in ensuring dual fidelity to the protocol and
participant care and safety. Respondents expressed an additional added value by having critical
thinking skills spanning an ability to grasp the “big picture” for the research aims and an ability to
attend to fine detail, especially safety tracking. Further, they also expressed personal and pro-
fessional satisfaction in their roles, being able to impart hope through this work and to nurture longer
relationships with study participants throughout the life of a study. Respondents enjoyed oppor-
tunities for work-life balance, many shared work schedules being traditionally daytime work hours
Jones et al. 57

and that they had opportunities to be upwardly mobile through engagement with the clinical re-
search teams.
Thirty respondents shared a story about their unique experiences as a clinical trials nurse.
Respondents shared stories as adult and pediatric clinical trials nurses, as nurses working in human
immunodeficiency virus (HIV), oncology and cardiology research, and as nurses working across the
spectrum of drug and device development processes and settings, including those who worked for
sponsors and other biotechnology companies. Saturation of the common themes was reached at the
15th story. We included excerpts from the contributed stories to lend voice to the study participants
(Table 3).
The respondents’ written narratives provided insights to the unique contributions of CRNs in
clinical trials, not only in navigating the dual fidelity to the protocol and study participants, but
nursing care of participants including a relationship between the patients and their caregivers in
imparting hope, ensuring continuity of care during the study treatment and in long-term follow-up,
and teaching. CRN stories further illustrated the range of critical thinking skills and expertise used in
solution finding and contributions as members of interdisciplinary teams and to the science under
study. CRNs working in clinical research enjoyed being on the cutting edge of research to make a
difference for future patient groups and an autonomy in their practice that contributed to work
satisfaction and work–life balance.

Clinical research nurse perceptions of educational preparation and role progression

Themes that emerged from the data in responses to the two questions: “Please tell us your feelings
about your educational preparation for your clinical research roles as a nurse” and “Please
describe your career progression from your first clinical research position as a nurse, to today”
included: (1) lack of educational preparation for the role; (2) skills increased with experience, and
(3) supervisory role emerged with experience.
Forty-five participants responded to the query about educational preparation. Data saturation was
noted after the 10th sequential response. Generally, the respondents affirmed that their BSN ed-
ucation prepared them to give excellent care of patients and critical thinking skills. Most had no
preparation in undergraduate school in subject matter related to clinical trials, and the CRN role.
They “learned on the job” regarding new medical product development, or regulatory affairs topics.
Moreover, they also learned from non-nurses who were either assisting with or external monitors of
the clinical trial data.
Those with graduate-level nursing education had increasing knowledge of nursing research and
research ethics but still felt they lacked an understanding of clinical trial research methods and
clinical trials operations in that coursework. One student working at the National Institutes of Health
Clinical Center relayed that they had many opportunities to learn more about clinical research at
their institution, but the initial education was “on-the-job” training. Two participants shared that
they had an MSN specifically in Clinical Research Management and later sought a terminal degree
in clinical research. One respondent felt like they were a novice again when they transitioned from
hospital nursing to a clinical research role, yet another stated that her work as an oncology nurse
helped prepare her for the role.
A number of trends emerged from the descriptions of career paths reported by the respondents.
Many of the respondents described their career trajectory starting at the bedside and moving upward
into assistant management, management, supervisory or directors’ roles. An initial theme that
emerged was that of the traditional career path upward movement and opportunities that were
presented while expanding skills and knowledge as a research coordinator. Several respondents
58 Journal of Research in Nursing 27(1-2)

Table 3. Story excerpts from CRN respondents.

Duel fidelity to the “I have two patients: the protocol and the participant in the trials.”
protocol and to “Advocating for study participants and their families, ensuring the study is conducted in a way
the patient that will produce meaningful outcomes to a larger patient population.”
“I am able to assess risk throughout the continuum of the protocol lifecycle and make impactful
decisions to participant safety and data integrity.”
“Bringing all of my nursing, science, and regulatory experience to operationalize clinical trials
with the highest critical thinking, ethics, scientific thought processes and ethical and protective
participant management skills.”
“I had a participant suffer a serious adverse event that required hospitalization. The study was
blinded and the inpatient staff and family wanted to have the study treatment un-blinded.
The PI also felt this way—at least initially. The sponsor did not want to un-blind at this
time….” “In the end the study was ended prematurely because of 2 patient deaths. There
was a lot of balancing care of the participant and care of the protocol in this situation.”

Relationships with “As nurses we build important nurse: patient relationships affording education of patients about
participants and their disease, research and clinical expertise and care…. We are part of a clinical trial that
families changes people’s lives.”
“I am on the frontline of the future of medicine . . . I am always learning and improving the health and
well-being of my patients…telling them that there is hope and almost always another choice.”
“The mother pulled me aside and said...‘I have been so frightened about all of this for so long,
about HCM (hypertrophic cardiomyopathy), about my son being sick and in a clinical trial, but
after today I feel better informed about HCM, stronger about it and safe.’ ‘She cried and
hugged me.’…I have been working with participants and their loved ones for the last two
years. The process of informed consent combined with the extensive baseline visit for this
study have presented the study team with opportunities to share their expertise and to begin
to forge trusting relationships with the participating family.”
“I’ve been able to play a part in providing patients something life changing through a clinical trial
that they would not have gotten in any other way. Seeing what a positive change research can
make in their lives is rewarding.”
“I was working on a study with Autistic children and we were having difficulty getting a good clear
EKG tracing, and to attempt them to stay still for 10 seconds was next to impossible. So with IRB
permission, we had the parents at night place the child in the car, drove around and they drove
to our parking lot. I got in the car with the portable EKG machine and while he was relaxed and
falling asleep I placed the lead stickers to his chest . . . and got our clear EKG tracing.”
“I met with the parents at the end of the participation in the study . . . each one sat with me,
wanting to tell me their story of their lives before this oral medication and now. They had each
been on continuous IV therapy and were able to be transitioned to one pill, twice a day.”
“I had a premature infant with CMV in a study and was with the mother and father when they
made the decision to withdraw support on a baby whose quality of life was rapidly worsening.
I was able to see the joyful and sorrowful side of research but not saturate too much of it.”
“An oncology patient with stage 4 bowel cancer. Over the next 5 years the pt (patient) would
return anywhere from 1-3 times a week for treatment and then eventually enter long-term
follow-up. What was supposed to be a poor prognosis turned into a miracle as the patient
fully recovered from his colon cancer and 4-month ICU stay. Ten years later that patient is still
alive and when I see him on campus he always stops and offers a warm hug and smile”
“On a diabetes study that required the implantation of a device meant to deliver a glucose
lowering drug to study subjects. Knowing what equipment would be needed and the ability to
educate the subject and his wife to allay their fears and watch the subject for any untoward
effects provided a smooth course for the subject.”

(continued)
Jones et al. 59

Table 3. (continued)
Contributing to “I am on the cutting edge of discovery.”
science and “I am a nurse running trials that are curing hepatitis C. I never thought that was something that could
interdisciplinary happen. In 2003 I was told it was something that could come back at any time. Over the last few
systems years and many drug formulations HCV is now a curable disease that is being treated with all oral
medication Respondents shared stories as adult and pediatric clinical research nurses, as
nurses working in HIV and oncology research, as nurses working across the spectrum of
drug and device development process, and of CRNs who worked for sponsors and other
biotech companies. . . I have expanded my role to work on other trials other than liver disease.”
“I used to work in HIV research when there were almost no medications available and every
participant was very very sick. Being involved in the first studies using drug combinations
stands out as a turning point in my career.”
I was able to give a Phase I drug for the first time in a human, EVER and continue to follow that
patient through the entire study, as well as follow that study through to publication.”
“One of our patients who had enrolled in an adjuvant chemotherapy trial for early stage breast
cancer was denied coverage for the study drug (by their insurance company). I was forced to
learn the details related to insurance coverage laws and exceptions to those laws . . . I was
able to get the costs of care already received covered but the patient had to be taken off the
trial. Since then we have worked as a team with the case manager to gain a better
understanding of the implications of conventional vs research costs and to create educational
materials to help inform patients about those implications.”
“I am asked to review protocols from a nursing clinical perspective. Is something feasible? Are
the visit windows wide enough?”
“I was asked to support a cardiovascular device trial. The team had a need for someone with a clinical
background to review medical records that were collected to support the study. As I reviewed these
records, I discovered errors in the data that had been submitted by clinical trial sites. This turned
out to be a widespread issue, and I suddenly found myself in a position where I was the only
individual with the necessary background to understand what went wrong and to develop a plan to
correct the problem.” “The study leadership team recognized the value of my contributions to the
study, and invited me to be a co-author on the study’s primary manuscript….the paper was
published in a top-tier medical journal. The experience helped to elevate the role of clinical
research nurses in the organization. ..Many members of the organization came to understand the
critical role of a nurse with a QA and compliance focus in clinical research.”
“I was offered the opportunity to join a speaker’s bureau. . . . It eventually led to being a faculty for the
NCI program on Community and Administrators Education on Clinical Trials. . . . Not only did the
speaking experience help my career- it introduced me to many mentors outside my home location.
Through my interactions I learned better ways of doing things, and gained more experience.”
“In auditing a device clinical trial I noticed the lack of controls around a cardiac valve device
made of porcine material, also not disclosed in the consent form. …the sponsor changed the
ICF and device management across the sites.”

described their role and skills sets evolving to include research or data, quality, or safety monitoring
with increasing responsibilities added over time. Skills within these roles included subject re-
cruitment, data management, and data cleaning for sponsors.
Supervisory responsibilities reported with the upward movement into management positions
included roles such as assistant nurse manager, nurse manager, and administration and director
positions. The career paths demonstrated opportunities within the clinical research arena to apply
learned skills from managing clinical trials to management of staff and resources necessary to run a
research unit, teams, or department. Others mentioned management of research registries and
repositories as well as clinical trials.
60 Journal of Research in Nursing 27(1-2)

One participant shared the opportunity to move up to an Associate Director position in clinical
research, managing budgets, and staff along with IRB responsibilities. Some of the research sites
mentioned included hospital settings, CROs, and academic settings. Although the employment sites
described varied, the skill sets seemed to be transferable to the different settings and built upon
previous skills and knowledge as careers progressed.
Another trend noted was that several of the respondents were Quality Assurance (QA) Specialists
or the QA nurse in their unit or hospital and participated in audits and data management. In addition
to the trends noted in career path progression, the respondents also reported a variety of certifi-
cations obtained along the way ranging from certifications in research to certifications in specialty
practice areas.
Overall, the responses to the question regarding career path progression were widely varied but
were similar in that the skills and experiences obtained in the work setting often led to the next level
of the career path (Table 4). Respondents described their career path as “typical” and “confidence
building” as they moved to the next level. Another described the desire to stay on the research
pathway as, “a feeling of making a difference and an opportunity to provide hope,” to patients that
would not otherwise have this option.

Summary observations
Applying Duffy’s Quality of Caring Model©. Emerging from the data, Duffy’s theoretical model was
aligned with the domains of practice which are well documented as a framework for the CRN within
the literature. This model supports the relationships described by CRNs in the context of team
science, adherence to the protocol and clinical care. These relationships included potential and
enrolled study participants (patients) and their families, relationships as a contributor to inter-
disciplinary teams within the institution (investigators, clinical nurses, laboratory personnel,
regulatory bodies, sponsors, monitors, government agencies, insurance companies), interdisci-
plinary teams outside of the institution (sponsors, monitors, government agencies), and their
immediate clinical research staff (other CRNs, other study staff, regulatory coordinators, schedulers,
institutional review boards, patient escort). Last, “relationship with self” included the themes of life-
long learning, job satisfaction, and work–life balance were described by respondents and represent
certain self-sustaining benefits as they progressed in their professional CRN roles.
We illustrate the relational aspects of quality caring associated with the work of Clinical Research
Nurses based on our qualitative findings in Figure 5.

Discussion and recommendations

This study gives voice to CRNs and provides insights into how CRNs make meanings of their
clinical research profession. The qualitative questions were open-ended, asking participants to “tell
us.” We avoided introducing bias, by not including language that suggested that written responses
and stories were to highlight unique contributions or to ascribe value of the CRN role. Themes
emerging from the meaning and story queries support the CRN Domain of Practice (CRN 2010
Domain of Practice Committee, 2009), Scopes, and Standards for Clinical Research Nursing
(American Nurses Association and International Association of Clinical Research Nurses, 2016).
Recognized by the ANA as a specialty practice in nursing in 2016, CRNs have existed for
decades making significant contributions to the clinical research enterprise. However, the role is
rarely described in undergraduate nursing coursework as a possible career path (Galassi et al., 2014).
CRNs are critical members of interdisciplinary teams and can work across varied settings. In
Jones et al. 61

Table 4. Education and role progression.

Lack of educational preparation “I didn’t know clinical research was an option in nursing school, which is really a
for the role shame because I went to a school linked with the organization I work for now. . .
. The only way clinical research was mentioned was in terms of a nurse scientist
performing nursing research.”
“Everything I know about clinical research I learned on the job.”
“In my BSN – NONE! Though I did attend _____University for an MSN in Clinical
Trials. This degree prepared me to take on many leadership roles and to
advance my career into something that I would have ever imagined.”
“I was fortunate to complete a MSN in Clinical Research Management early in my
career. Subsequently I also completed a research doctorate in health sciences. I
struggled to find a doctoral program that matched my career objectives…Most
DNP programs were too focused on advanced clinical practice”

Skills increased with experience “When I took on a research role, I was the first research RN in my department and
I was completely self-taught. I learned a lot from my first study monitor.”
“Transitioning to a research role was very difficult. Nothing in my past career or
academic education prepared me for the job. I feel like I went from novice again
overnight. . . . the transition occurred primarily through on the job training. It
took a great deal of time.”
“My career as an oncology nurse made it much easier to transition into this role.”

Supervisory roll emerged with “I came in knowing nothing about being a research nurse. I learned on the job.
experience Now I have a position as a RN Project Manager where I lead, manage and
guide the study teams to perform high quality research.”
“I started out as what we were calling a study coordinator, but I was basically a one
nurse clinical trials show, doing all the work for clinical trials in my department. I
also worked for several years part time for another department, managing
research for investigators in several departments. Now I am called the Associate
Director of Clinical Research in my department with the goal of setting up a
departmental research structure, though I still handle a lot of task based work
such as IRB applications, communications with other departments and
sponsors, budgets, and patient care, in addition to supervising staff. I also do
some work as a monitor on several investigator initiated studies throughout the
hospital.”
“I started as a clinical research nurse coordinator progressed into a research nurse
supervisor and manager at an academic institution. Then I moved into
administration as a clinical research director for a hospital system and finally a
clinical trial manager, associate director for a Contract Research Organization
(CRO).”

addition to nursing knowledge, and clinical research expertise, the caring attribute of CRNs enables
them to successfully navigate multiple relationships and systems to effectively and safety coordinate
multiple clinical trials and simultaneously care for clinical research participants. The importance of
continuing to further explore and define the role of the clinical research nurse is foundational to the
research enterprise on several levels. For example, research teams are moving toward hiring less
costly personnel to collect research data in order to reduce the expense of conducting clinical trials.
This movement can clearly cause potential risk to the research participates in terms of monitoring for
changes in clinical conditions as nurses are so highly trained to do (Jones et al., 2015; McCabe et al.,
2019).
62 Journal of Research in Nursing 27(1-2)

Figure 5. Quality caring factors and clinical research nursing roles.

The Quality Caring model has been applied to various nursing roles in adult and pediatric settings
(Edmundson, 2012; Meunier-Sham et al., 2019; O’Nan et al., 2014). We were able to attribute CRN
roles to the eight quality caring behaviors described by Duffy and Hoskins (2003) and found it
complementary to the existing CRN Domain of Practice (Figure 6).

Study limitations
The limitations of this study included the snowball sampling recruiting CRNs from a professional
association listserv and by using social media invitations. The respondents may be considered
self-selected to get their voices heard and limited to those comfortable in written English.
Moreover, the respondents were mostly performing their clinical research roles at academic
medical centers (67%); therefore, there may be bias in the results. There was a greater than
expected initial response rate; however, many more survey respondents contributed descriptive
and demographic information, and did not complete the open-ended section suggesting survey
fatigue or time conflicts. On average, 40 of the 97 respondents (approximately 41%) took the time
to share their written stories in the open-ended section of the survey. The majority of participants
resided in the eastern regions of the United States.

Recommendations
Future research should explore the unique education needs and contributions of CRNs. Additional
research applying nursing theoretical models, such as Duffy’s Quality Caring Model should be
performed, to gain deeper understanding of the CRN specialty practice. Research on CRN workload
and self-care would also be beneficial. With the onslaught of COVID-19, additional role factors
should be studied, such as safety of CRNs in the workplace during a global pandemic, team science,
and opportunities for CRN innovations such as the use of telemedicine, electronic signature
Jones et al. 63

Figure 6. Model of the clinical research nurse domain of practice in a quality caring context.

technology for clinical trial informed consents, and mobile technology for data collection and
remote site monitoring visits.

Conclusion
This study collected qualitative survey responses from experienced clinical research nurses who
were queried about their individual perceptions about the meaning of their CRN work, sharing a
story from that work, and describing their career pathways and educational preparation. The Quality
Caring Model© provides a systematic way to demonstrate the caring and relationship aspects of
CRN roles in the context of complex clinical trials and interdisciplinary systems. COVID-19 has
brought worldwide attention to the importance of bringing new treatments to the world in a timely
manner through quality research. Clinical Research Nurses are key contributors to the outcomes of
quality research exemplifying the caring and knowledge of the nursing profession.

Key points for policy, practice, and/or research

· Clinical Research Nurses make significant contributions to the care of patients and to the
integrity of research in the context of complex clinical trials.
· Nursing academic education should incorporate more information about clinical trials
research and the role of clinical research nurses.
· The Quality Caring Model provides a framework for illustrating the strength of nursing
relationships with patients, with each other, with interdisciplinary team systems, and to
the greater community.
64 Journal of Research in Nursing 27(1-2)

Acknowledgments
The authors wish to acknowledge the IACRN Research Committee who encouraged us to develop and conduct
this study and by the willingness of the IACRN to assist in circulating the study invitations to the membership.
We also wish to acknowledge those who assisted us by sharing this study with other CRN colleagues so that we
could get a wider response, and of course, the CRN survey participants who shared their stories.

Declaration of conflicting interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or pub-
lication of this article.

Funding
The authors disclosed receipt of the following financial support for the research, authorship, and/or publication
of this article: This work was supported in part by The Ohio State University, Center for Clinical Translational
Science, grant number UL1TR002733 from the National Center for Advancing Clinical Translational Sciences
(NCATS), National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program.

Ethics
This study was reviewed by our university’s IRB and designated as exempt.

ORCID iDs
Carolynn T Jones  https://orcid.org/0000-0002-0669-7860
Catherine A Griffith  https://orcid.org/0000-0002-3145-3649
Cheryl A Fisher  https://orcid.org/0000-0002-2884-8113
Elyce Turba  https://orcid.org/0000-0002-0346-667X

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Carolynn T Jones, DNP, MSPH, RN, FAAN, is Associate Professor of Clinical Nursing at The
Ohio State University College of Nursing and the OSU Center for Clinical and Translational
Science.
Catherine A Griffith, PhD, RN, is a Clinical Research Nurse in the Translational and Clinical
Research Centers at Massachusetts General Hospital, Boston, MA, USA.
Cheryl A Fisher, EdD, RN, is Associate Professor, Nursing Informatics, University of Maryland
School of Nursing, Baltimore, MD, USA.
Kathleen A Grinke, MSN, RN, is a Clinical Research Nurse in the Translational and Clinical
Research Centers at Massachusetts General Hospital, Boston, MA, USA.
Rosemary Keller, PhD, RN, is a Global Development & Operations Clinician at Pfizer, Inc.,
Collegeville, PA, USA.
Hyacinth Lee, PhD, RN, oversees the day-to-day operations of the Translational Research Unit at
the University of Washington Medical Center, Seattle, WA, USA.
Michelle Purdom, PhD, RN, is Vice President of Clinical Research and Operations for TG
Therapeutics, Inc., New York, NY, USA.
Elyce Turba, MSN, RN, OCN, is a Clinical Research Nurse at Moffitt Cancer Center in Tampa
Bay, FL, USA.