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Abstract
Objective: To identify factors associated with job satisfaction and retention, we surveyed a large cohort of
clinical research coordinators (CRCs). In recent years, the clinical research coordinator has changed from a
semi-permanent role to one that has a high turnover rate. The CRCs are integral to clinical research and
instability in this role can cause patient stress and increase the burden on clinical teams through un-
necessary delegation of resources toward hiring and retraining new talent. The cultural shift toward CRCs
as a temporary position may be driven by the perspective that the role positions an individual for other
health care careers, but understanding what influences low retention rates are necessary.
Methods: A survey containing 13 multiple choice or open-ended and 32 Likert scale questions was
distributed to previous and current CRCs using REDCap. The questionnaires were self-administered and
completed over a 12-month period between October 11, 2017, and September 16, 2018.
Results: A total of 85 CRCs completed the study. From the 32 potential predictors of retention, we
investigated 9 significant predictors: salary, work setting, understanding the role, level of CRC, under-
standing protocol development, actively engaged principal investigator (PI), having a collaborative role
with PI, feeling respected by PI, and having a close relationship with PI. Adequate salary, greater respect,
collaboration, and engagement from the PI were significantly associated with higher retention. Surpris-
ingly, greater workload and lack of opportunity for professional growth were not associated with
retention.
Conclusion: The CRCs who feel respected and engaged by the PI and are adequately compensated are
more likely to have higher job satisfaction and retention.
ª 2020 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND
license (http://creativecommons.org/licenses/by-nc-nd/4.0/) n Mayo Clin Proc Inn Qual Out 2021;5(2):265-273
C
linical research studies are conducted consent, and randomization), conducting
Neurology, Vanderbilt
by a multidisciplinary research team study visits (collecting biofluids, monitoring University Medical Center,
including but not limited to clinical compliance, and documenting adverse Nashville, TN (D.A.B.,
staff, regulatory staff, and administrative events), maintaining study regulatory docu- A.C.P., D.O.C.); Hunting-
ton Study Group,
personnel. The coordination among such a ments, reporting adverse events to the appro- Rochester, NY (J.G.); and
comprehensive team is often led by a clinical priate regulatory authorities (eg, institutional Department of Biostatis-
research coordinator (CRC), whose daily re- review board, sponsor, US Food and Drug tics, Vanderbilt University
Medical Center, Nashville,
sponsibilities vary significantly but ultimately Administration, and National Institutes of TN (Y.-C.L., H.K.).
serve as the liaison between study sponsor Health, conducting research in accordance
and patients and clinical, regulatory, and with Good Clinical Practice guidelines, manag-
administrative staff. The CRCs are integral ing study budgets, maintenance of electronic
for the success of clinical research due to their study records, and general liaison between
wide range in responsibilities. Clinical research study sponsor and site principal investigator
coordinators are typically composed of clinical (PI).
research nurses, clinical trial nurses, research Hiring a CRC represents a significant in-
nurse coordinators, and study coordinators.1 vestment in time and training to properly
The main tasks that CRCs conduct for multi- carry out job responsibilities. Turnover in
center trials include recruitment of patients this role is costly; these costs are related to
into clinical trials (screening, enrollment, salary, effort of the employee and trainee,
Mayo Clin Proc Inn Qual Out n April 2021;5(2):265-273 n https://doi.org/10.1016/j.mayocpiqo.2020.09.014 265
www.mcpiqojournal.org n ª 2020 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. This is an open access article under
the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
MAYO CLINIC PROCEEDINGS: INNOVATIONS, QUALITY & OUTCOMES
time for education and development, market- administrators within the Huntington Study
ing and recruitment, loss of productivity dur- Group. The 45-question self-administered
ing orientation and training, and emotional questionnaire used a combination of multiple
costs of turnover on current staff.2 Because choice and open-ended (questions 1-13) and
of this investment, it is advantageous to retain 5-point Likert scale (questions 14-45) ques-
individuals in this position for extended pe- tions ranging from strongly disagree (0) to
riods, positioning this role as a long-term strongly agree (5), outlined in Tables 1 and
career. Currently the CRC role has become a 2. The questions addressed research setting,
temporary position in which coordinators duration in position, prior experiences, rela-
seek to gain clinical experience before medical tionships with study participants and research
school, nursing positions, or other graduate staff, compensation, professional support,
programs. additional training opportunities, and oppor-
With the increase in regulatory oversight tunity for career advancement. Information
among clinical trials, the demands and expec- for participant retention was recorded using
tations of CRCs have increased and require an ordinal response category with the
additional skills, training, and medical knowl- following duration categories: 0 to 1, 1 to 5,
edge. Depending on experience and interest, 6 to 10, 11 to 16, and more than 16 years.
CRCs may actively participate in additional The study was administered electronically
investigator-initiated projects, manuscript through the secure web platform REDCap,
preparation, and conference presentations. and participants were identified using the
The expansion of the CRC role includes addi- Huntington Study Group list serv and profes-
tional responsibilities and increased workload sional contacts. The survey was distributed to
for individuals, which adversely affect their 113 participants identified as previous or cur-
job satisfaction and ultimately duration in rent CRCs from 32 academic medical centers.
the position. A study by Anderson and Milko- We collected participant email address, sex,
vich found that job satisfaction was a signifi- and work setting but did not collect informa-
cant predictor of retention with professional, tion related to age, previous work back-
managerial, and technical employees.3 Simi- ground, level of education, or job title (ie,
larly, Gullatte and Jirasakhiran2 found that CRN, clinical research associate, or clinical
lack of job satisfaction was the most cited research nurse).
reason for staff turnover.
Given the important role of CRCs on the Statistical Analyses
success of clinical research and the necessary Predictors of retention were identified using
investment of resources for their success, it is logistic regression models with select variables
advantageous to identify factors associated as potential modifiers. Variables were selected
with job satisfaction and increased retention. based on a principal component analysis bi-
There is limited literature evaluating these fac- plot that identifies groups of predictors with
tors and the existing studies are less relevant similar responses (Statistical Software R,
considering the rapid pace at which the struc- version 3.5.2). Figure 1 is a visual representa-
ture of clinical research evolves. This study tion of this bi-plot that identifies the select
sought to identify specific predictors of reten- questions (predictors) that cluster together.
tion from 32 different potential factors. This analysis identified 3 clusters of questions
containing 9 Likert-scale predictors to be
METHODS investigated for their role in retention. Single
A 45-question online survey was developed by predictor logistic regressions were run on
the clinical research team at Vanderbilt Uni- these groups of questions that primarily
versity Medical Center and administered over related to compensation and relationship
a 12-month period between October 11, with the PI. Retention was examined as an
2017, and September 16, 2018. Questions ordinal and binary variable (low ¼ 0-5 years
were based on anecdotal reports from CRCs, and high ¼ 6þ years), yielding no differences
clinicians and clinical research staff within in significant predictors between the 2 statisti-
the clinic, clinicians and research staff at the cal models and thus only binary comparisons
University of Rochester, and research are reported here with the corresponding
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EMPOWERING THE CLINICAL RESEARCH COORDINATOR
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MAYO CLINIC PROCEEDINGS: INNOVATIONS, QUALITY & OUTCOMES
predictors (CRC level and work setting) based setting compared with a private hospital
on anecdotal interactions with peers. Partici- (P¼.04). Participants with increasing satisfac-
pants were 9.5 times more likely to have tion with their good salary were 1.544 times
high retention if they worked in an academic more likely to have high retention compared
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EMPOWERING THE CLINICAL RESEARCH COORDINATOR
Role of PI on Retention FIGURE 1. Response trends for Likert scale questions. Responses for the 32
Another major predictor of retention among Likert scale questions identify several clusters of questions with similar
current and previous CRCs related to the response trends. Each vertical column represents a different question with
the number of every fifth question identified on the x-axis (1, 5, 10, etc).
role of the PI. The PI had a significant impact
The number of participant responses from strongly disagree to strongly
on CRC retention when it relates to being agree for each box is indicated with different shades of blue to yellow: blue
collaborative, engaged, and respectful indicates fewer responses and yellow indicates a greater number of re-
(Figure 3). The influence of the PI on CRC sponses as estimated with the vertical scale bar. Clusters of questions are
retention is substantial because there were 4 indicated with black bars with an asterisk (*) identifying a cluster of ques-
independent predictors relating to the PI. Par- tions related to the role of the principal investigator that were all significant
ticipants who believed they had a collaborative predictors of retention.
role, had a close working relationship, were
well-respected, and thought that their PI was
actively engaged were 1.770, 3.08, 2.387,
and 1.947 times more likely, respectively, to regulatory compliance duties.5 A study in
have high retention (P<.05, P<.001, P<.01, 1996 revealed that CRCs performed more
and P<.05). than 128 different responsibilities.6 The
To identify the single most important pre- CRCs usually interact with patients more
dictor of retention, we included all 9 signifi- than the PI for the duration of a trial. This in-
cant predictors in a regression model. In this cludes study assessments, scheduling, escort-
model, the only predictor that retained its sig- ing patients around research facilities, being
nificance was having a close working relation- a caregiver, and even being a patient advo-
ship with the PI (data not shown), suggesting cate.1 Cooper and Lomax7 state that CRCs
that this particular variable best predicts make a significant difference in participant
retention. recruitment, retention, and study efficiency.
The CRCs are not only advocating for the suc-
Factors Unrelated to Retention cess of the particular study but many times
The remaining 7 predictors that were not asso- advocate for successful patient treatments.
ciated with retention were number of trials, Those roles create a balancing act that the
professional growth opportunities, healthy coordinator must face.4 Research coordinators
work environment, rewarding patient interac- are there to make sure that patients have a
tions, well-structured work environment, pub- good understanding of the protocol, help pa-
lications and conference presentations, and tients make an informed decision on whether
having enough time to get their work done. to participate in a trial, the voluntary nature
of a clinical trial, and the ability to withdraw
DISCUSSION from the study at any point without conse-
Clinical research coordinators are largely invis- quences.4 Although the PI is responsible for
ible participants in clinical research4 but their the overall conduct of the clinical trial, the
role is critical. According to the Association of CRC is responsible for the daily activities.5
Clinical Research Professionals, the success of Due to the number of roles or duties for
clinical trials relies on CRCs, who carry out which a coordinator is responsible, it is diffi-
many of the key clinical, administrative, and cult and time-consuming to hire and train
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MAYO CLINIC PROCEEDINGS: INNOVATIONS, QUALITY & OUTCOMES
# of participants
# of participants
# of participants
30 P=.04 P<.001 P=.043
15
15
20 10
10
10 5 5
0 0 0
Hospital Private Academic CRC 1 CRC 2 CRC 3 CRC 4
ee
e
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re
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Ag
ag
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isa
dis
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D
ng
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St
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St
A B C
Understood aspects of protocol
Understanding role of CRC development
30 OR=0.6087 25
OR=2.181
P=.009
# of participants
# of participants
20 P=.01
20
15
10
10
5
0 0
ee
ee
ee
ee
ee
ee
l
l
re
tra
re
tra
gr
gr
gr
gr
gr
gr
Ag
Ag
eu
eu
isa
isa
a
isa
isa
ly
N
ly
N
D
d
ng
ng
ly
ly
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ng
ro
ng
St
ro
St
ro
St
St
D E
Low High
FIGURE 2. Five significant predictors of retention. Agreement with: (A) work setting, (B) clinical research coordinator (CRC) level, (C)
good salary, (D) understanding role of CRC, and (E) understood aspects of protocol development. Low retention (Low) defined as
0 to 5 years, and high retention (High) defined as 6 or more years. OR ¼ odds ratio.
study we did not specifically gather information investigator-initiated trials, run laboratories,
regarding respondents' previous education and teach, in addition to travel requirements.
levels or training experience. Interestingly, the Although the National Institutes of Health
survey included a question related to adequacy define the PI as the individual who is primarily
of training (Table 2, question 3) for their current responsible for the clinical trial,10 it is clear to
CRC role, and this was not a significant predic- all research staff that CRCs more often com-
tor of retention. Conversely, an individual’s plete many of the responsibilities formally
involvement in protocol development results designated to the PI.11 The demands on a suc-
in 2.181 greater odds of higher retention. Partic- cessful PI are extensive and as a result, a CRC
ipation in protocol development would occur may feel a lack of engagement or support from
primarily in investigator-initiated trials and a their PI and other research staff. Participants
coordinator may feel a greater sense of auton- who did not feel engaged with their PI were
omy and understanding of clinical research. 90% less likely to have high retention
The second primary cluster of significant (Figure 3A). A PI who is actively engaged
retention predictors related to the role of the with a sponsor-initiated CRC would be readily
PI. It is common to see PIs who oversee a large available to sign source documents, identify
amount of clinical trials, have extensive clinical potential study participants, and review labo-
responsibilities, are committed to expanding ratory test results and other time-sensitive
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MAYO CLINIC PROCEEDINGS: INNOVATIONS, QUALITY & OUTCOMES
# of participants
# of participants
P<.05
P<.05
15 15
10 10
5 5
e 0 0
ee
ee
e
e
e
l
l
re
re
re
re
tra
tra
re
re
gr
gr
ag
Ag
ag
Ag
ag
ag
eu
eu
isa
isa
dis
dis
ly
ly
N
N
D
D
ng
ng
ly
ly
ro
ro
ng
ng
St
St
ro
ro
St
St
A B
Felt respected by PI Close relationship with PI
25 25 OR=3.08
OR=2.387
P<.01 P<.001
20 20
# of participants
# of participants
15 15
10 10
5 5
0 0
e
ee
ee
e
e
e
l
l
re
re
re
re
tra
tra
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gr
gr
ag
Ag
ag
Ag
ag
ag
eu
eu
isa
isa
dis
dis
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N
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ng
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St
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C D
Low High
FIGURE 3. Four significant predictors of retention related to the role of the principle investigator (PI).
Agreement with (A) PI engagement, (B) collaborative role, (C) respect, and (D) a close relationship with
the PI was associated with greater odds of higher retention. Low retention (Low) defined as 0 to 5 years,
and high retention (High) defined as 6 or more years. OR ¼ odds ratio.
documents that sponsors may require. A PI that relies heavily on the camaraderie of all
who is actively engaged in the research outside participants. As such, the stronger the rela-
of a clinical trial would help with data inter- tionship between team members and the PI,
pretation and provide opportunities for the longer people will want to stay. To this
authorship5 and professional growth. extent, we found that a participant is more
Additionally, we found that the odds of than 3.08 times more likely to have high
having higher retention is 77% greater in par- retention when they have a close working
ticipants who thought that their PI was relationship with their PI (Figure 3D).
collaborative (Figure 3B). According to a Furthermore, in a multiple regression model
recent study, effective managers are identified that includes all 9 significant predictors iden-
as those who take time to manage relation- tified in this study, having a close working
ships with their employees as well as their relationship with the PI is the single most
bosses.12 It is clear that investing in a profes- important predictor of retention. A previous
sional relationship between CRC and PI in- study found that employers who demon-
volves utilizing each other's strengths and strated a sense of motivation, interest, and
making up for each other's weaknesses.12 concern for their employees' well-being led
Clinical research is a multidisciplinary field to higher retention.13
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EMPOWERING THE CLINICAL RESEARCH COORDINATOR
Respect from the PI is the final predictor of 37232 (daniel.claassen@vumc.org Twitter: @claassendoc or
retention. One reason for high turnover rates @claassenlabvumc).
among health care professionals is perhaps ORCID
due to a lack of recognition and positive feed- Danielle A. Buchanan: https://orcid.org/0000-0001-
back from their employers.9 To this end, we 5057-2523
found that the odds of having higher retention
is 2.387 times more likely than for someone
who believed they were not respected by their
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