Training Impact on Novice and Experienced Research Coordinators
The Qualitative Report
Training Impact on Novice and Experienced Research Coordinators
Stephen Sonstein 0 1 2 3 4
0 Eastern Michigan University , USA
1 Stephanie Swords MA, CCRP Johns Hopkins University
2 Linda S. Behar-Horenstein University of Florida , USA
3 Alena Prikhidko PhD, candidate University of Florida , USA
4 JoNell Efantis Potter Ph.D. University of Miaim
Part of the Translational Medical Research Commons This Article has supplementary content. View the full record on NSUWorks here: https://nsuworks.nova.edu/tqr/vol22/iss12/3
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Training Impact on Novice and Experienced Research Coordinators
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Research reported in this publication was supported by the University of Florida Clinical and Translational
Science Institute, which is supported in part by the NIH National Center for Advancing Translational
Sciences under award number UL1TR001427. The content is solely the responsibility of the authors and does
not necessarily represent the official views of the National Institutes of Health.
Linda S. Behar-Horenstein; JoNell Efantis Potter Ph.D.; Alena Prikhidko PhD, candidate; Stephanie Swords
MA, CCRP; Stephen Sonstein PhD; and H Robert Kolb RN BS CCRC
This article is available in The Qualitative Report: https://nsuworks.nova.edu/tqr/vol22/iss12/3
Training Impact on Novice and Experienced Research
Linda S. Behar-Horenstein
University of Florida, Gainesville, Florida, USA
JoNell Efantis Potter
University of Miami, Miami, Florida, USA
University of Florida, Gainesville, Florida, USA
Johns Hopkins University, Baltimore, Maryland, USA
Eastern Michigan University, Ypsilanti, Michigan, USA
H. Robert Kolb
University of Florida, Gainesville, Florida, USA
Competency-based training and professional development is critical to the
clinical research enterprise. Understanding research coordinators?
perspectives is important for establishing a common core curriculum. The
purpose of this study was to describe participants? perspectives regarding the
impact of online and classroom training sessions. 27 participants among three
institutions, completed a two-day classroom training session. 10 novice and
seven experienced research coordinators participated in focus group
interviews. Grounded theory revealed similarities in novice and experienced
coordinator themes including Identifying Preferences for Instruction and
Changing Self Perceptions. Differences, seen in experienced participants,
focused on personal change, in the theme of Re-Assessing Skills. Infrastructure
and cultural issues were evident in their theme, Promoting Leadership and
Advocacy. Novice participants recommended ways to improve training via their
theme of Making Programmatic Improvements. Participants reported a clear
preference for classroom learning. Training played an influential role in
changing participants? self-perceptions by validating their experiences. The
findings provided guidance for developing a standardized curriculum. Training
must be carefully tailored to the needs of participants while considering
audience needs based on work experience, how technology can be used and
offering content that is most urgently needed. Keywords: Clinical Research
Coordinators, Competency-Based Training, Grounded Theory, Online Training
Identifying and implementing competency-based training and professional
development programs are critical to the future of the clinical research enterprise. According
to the International Conference on Harmonization Good Clinical Practice (ICH) individuals
who conduct trials should be qualified by education, training, and experience
(U. S. Department
of Health and Human Services Food and Drug Administration, 1996)
. The training and
education of research staff is integral to the success of the team and the studies they work on.
However, standardization of training across all research staff, and within specific roles of the
team, is limited
(Duane, Granda, Munz, & Cannon, 2007)
. Developing a skilled professional
workforce coincides with the World Health Organization?s initiative on transforming health
(World Medical Association, 2013)
The current model of non-standardized training, given via online modules, may not
adequately meet ICH guidelines or ensure professional competence. Competency development
by definition refers to an observed ability that develops from an integration of knowledge,
skills, values, and attitudes
(Dreyfus, 2004; Frank et al., 2010)
. In Medicine, professionalism
is often equated with competency. Epstein and Hundert (2002) suggested ?professional
competence is the habitual and judicious use of communication, knowledge, technical skills,
clinical reasoning, emotions, values, and reflection in daily practice for the benefit of the
individual and community being served? (p. 226). In the clinical research enterprise, each team
member must acquire the necessary knowledge, training and experience so that they can
successfully perform the responsibilities for conducting clinical research. However, the issue
of ensuring competency is yet another matter.
A standardized training model based on common core competencies is instrumental to
a professional workforce?s ability to meet the demands of an evolving clinical research
landscape. The Joint Task Force for Clinical Trial Competency (JTF) described eight domains
and related cognitive competencies
(Sonstein, Seltzer, Li, Silva, Jones, & Daemen, 2014)
Subsequently, these competencies have been vetted by CTSA investigators on the Enhancing
Clinical Research Professionals' Training and Qualifications (ECRPTQ) NCATS supplement
(Calvin-Naylor et al., 2017)
. Movement towards competency-based educational
standards coincided with recommendations from a Clinical and Translational Science Award
(CTSA) Research Coordinator Taskforce. They called for expanding the scope of clinical
research coordinators roles. Moreover, the task force recommended that enhanced educational
opportunities were crucial to the support of professional development
(Speicher et al., 2012)
Evidence shows there are insufficient numbers of adequately trained and educated
professionals in the workforce to address the overall evolving demands in the clinical research
(Dickler, Korn, & Gabbe, 2006; Drain, Robine, Holmes, & Bassett, 2014; Silva et
. Educational evaluation research belays the critical need.
The training course reported in this study consisted of a prerequisite on-line course, the
CITI Program?s Clinical Research Coordinator (CRC) online course to provide research staff
with basic knowledge. Using lectures, case studies, and hands-on work with realistic research
materials, the in-person training expanded and developed further online learning. This study
was designed to implement and evaluate a standardized competency-based training process for
clinical research personnel. The method used was grounded in a collaborative approach leading
towards generating best practices across research universities. Recognizing the need to tailor
learning to adults, there has been a decided shift towards the use of problem-based learning
guided by experiential learning theory
(Jones, Jester, & Fitz-Gerald, 2010; Sternberg & Zhang,
To simulate experiential learning, recently published results from SPRINT were used
to develop interactive activities
(SPRINT Research Group, 2015)
. Participants were instructed
to read both the edited SPRINT protocol and select study publications. The protocol and its
informed consent were used throughout the training, during the presentations and case
discussions. In addition, participants were required to read an overview of the core competency
framework for the clinical research professional since those competencies were covered during
the in-person course (Sonstein, Seltzer, Li, Silva, Jones, & Daemen, 2014)
Medicines Development and Regulation
Scientific Concepts and Research Design
Ethical and Participant Safety Considerations
Medicines Development and Regulation
Clinical Trials Operations; Leadership and Professional
Development; Communication and Teamwork
Ethical and Participant Safety Considerations
Ethical and Participant Safety Considerations
Study and Site Management
Data Collection &
Case Studies: Data
Study Monitoring and
Adverse Events (AE)
Case Studies: AE &
CITI no specific
CITI no specific
& budgeting, CRC
Clinical Trial Operations
Ethical and Participant Safety Considerations; Clinical
Data Management and Informatics
Medicines Development and Regulation; Clinical Trial
Study and Site Management
Study and Site Management
Ethical and Participant Safety Considerations; Clinical
Participants were asked to send certificates of completion to the study team. The CITI
Program?s Clinical Research Coordinator (CRC) course focused on the operational and
regulatory elements guiding the ethical conduct of clinical research. Course instructors and
content experts evaluated the CITI CRC Course and identified the corresponding competency
domain tie-ins for the in-person course (see Table 1). During the in-person course, participants
were asked to role-play in groups of three during the Informed Consent break-out sessions.
Each person took a five-minute turn acting as a patient, a recruiter/coordinator, and an observer.
After each turn, five-minutes were spent providing feedback to the recruiter.
The purpose of this study was to describe participants? perspectives regarding the
impact of the research coordinator online and classroom training sessions towards the
development of a standardized competency training model. Understanding these perspectives
is important for training and establishing a common core curriculum. However, the overall goal
of training is to ensure that the translational science workforce has the skills and knowledge
necessary to advance translational science.
We used qualitative methods to analyze the text of the transcripts as this is the preferred
approach when an understanding of participants experiences is the researcher?s goal. Because
there has been a dearth of research about the impact of research coordinator online and
classroom training, we used a grounded theory approach with the hope that findings might
guide the development of a standardized competency training model.
Both new and experienced research coordinators (n=31) from three institutions located
in the Northeast and Southeast participated in a two-day pilot training course for this study.
The program was evaluated using surveys and focus groups. Clinical research staff signed
informed consent. Of these, 27 completed the course and a subset of participants agreed to take
part in Focus Group (FG) interviews. FG participants included 13 females, four males, eight
underrepresented minorities (URM) and 9 non-URMS. By institution, there were seven
participants from the Southeastern private university, four from the Northeast private
university, and six from the Southeastern university. Ten participants were designated as
novice (0-up to 10 years); seven were experienced (more than 10 years) based on years
employed as a research coordinator. The study was approved by the institutional review board
We conducted two one-hour focus groups one with novice and the other with
experienced research coordinators. Participants in both groups were asked the same questions
which sought to illicit their beliefs about: (a) preferences for online or classroom learning; (b)
essential skills or competencies; (c) changes in confidence level; (d) characteristics of ideal
research coordinators; (e) influence on enacting roles; and (f) program influence on becoming
an ideal research coordinator.
Focus group (FG) methodology, a qualitative approach, relies on the use of a skilled
interviewer (moderator) to collect narrative data related to the shared experiences among a
group of participants or to develop an understanding regarding a phenomenon. This approach
affords interactions between interviewer and participant and among all participants. FGs also
allow for varied viewpoints to be shared, permits exploration and elaboration of what has been
stated, and encourages the collection of a greater range of responses. The interactions among
participants enhance data collection by implicitly providing checks and balances on one
another, which tends to ferret out false or extreme viewpoints. The extent of shared views or
the extent of diversity in viewpoints can be quickly assessed. FG dynamics may generate new
thinking about a topic, which is likely to foster more in-depth discussion
Catalanotto, & Nascimento, 2015; Creswell, 2002; Estrada et al., 2016; Krueger, 1998;
Treadwell, Catalanotto, Warren, Behar-Horenstein, & Blanks, 2016)
The first, third, and last authors independently read the FG transcripts as separate
datasets and formulated impressions of emergent themes. During a meeting, they shared
individual impressions of the dataset. They reached consensus regarding emergent themes and
related conceptual definitions and developed a codebook to guide subsequent phases of
analysis. The authors used gerunds to maintain the actions implied by the participants
(Charmaz, 2014; Salda?a, 2015)
. Next, while reading line by line, one of three authors while
acting as a primary analyst extracted selected text representative of the conceptual definition
related to the theme. After the primary analyst extracted text, a second analyst audited the
analysis to indicate agreement or disagreement with selected text or suggested moving data to
better fitting codes as appropriate. This iterative process led to clarifying themes, locating
quotations to support themes and illustrating the thematic similarities and differences among
participant groups. The first author checked all areas of differences and sent a list to the primary
analyst assigned to those areas where agreement was not reached. In all cases the primary and
secondary analyst reached consensus. This process ensured that the primary analyst stayed
immersed in the data and enhanced their analytical acumen. The use of two analysts
strengthened the creditability and dependability of the findings.
Grounded Theory Approach
We visually describe the steps undertaken to explain how we used the grounded theory
approach in this analysis. However, we acknowledge that we cannot fully explain the cognitive
and intuitive leaps taken when drawing inferences related to sensitizing concepts
. By way of offering the reader transparency, we carefully explicate our
collective positionalities and describe how our roles, experiences and knowledge bases
informed the analysis and interpretation (see Figure 1).
1. Each researcher independently read the transcript of novice research
coordinators and developed a set of emergent themes.
2. Each researcher open-coded the text that was relevant to the study?s purpose
to identify emergent themes and sent those themes to the first author.
3. The first author developed a collective set of themes. All of the authors met to
discuss themes and subthemes and reached consensus. They developed
conceptual definitions for each theme and subtheme. Conceptual definitions
were identified with the use of gerunds.
4.One of the three researchers read the transcript line-by-line and selected text
that is aligned with the conceptual definition for each theme and subtheme. A
second researcher confirmed or refuted the selection of each text passage. Areas
of disagreement were discussed and consensus was reached. For example, text
aligned with one of the selected theme, see Panel #1. For text aligned with one
of the selected subthemes, see Panel #2.
5. Researcher used the constant comparison method used throughout the
analysis. Representation of 50% or more of the respondents was a factor in
determining whether or not a theme or subtheme was amply supported. Some
subthemes were moved to better fitting themes while others are eliminated due
to lack of representative text. For example, if there was only one representative
text excerpt it was considered an outlier and eliminated from further analysis.
This step was aligned with Charmaz?s (2014) conception of focused coding.
6. We used a methodical, systematic and rigorous inductive method of analyzing
the text to ensure that themes and subthemes were supported by participants?
spoken words. This process was repeatedduring the analysis of experienced
research coordinator transcript.
Panel 1. Linking text excerpts to a theme
Panel 2. Linking text excerpts to a subtheme
The first author is an experienced and published qualitative researcher. She has
conducted multiple studies with heath care professionals. She participated in the
conceptualization of the study. She urged the use of qualitative inquiry to develop an
understanding of participants? experiences and preferences. The third author, a research
assistant for the first author, has extensive experience in qualitative research. She was not
affiliated with the study prior to data analysis. The last author is an Assistant Director of
Clinical Research and Research Participant Advocate for the UF CTSI within the Regulatory
Knowledge & Research Support services and Work Force Development Directorate. He
develops coordinator directed training and programs geared towards professionalization of the
clinical research workforce. He has more than 30 years of firsthand experience of being a
Clinical Research Coordinator and Professional, working at all levels and in all phases of
clinical research. In this context, along with a seasoned worked group that included the other
authors and a community of engaged coordinators, he participated in and helped facilitate study
design. His pre-conceptions and contextual relationships between the findings and his lived
experience brought a particular level of insight.
Alterations in beliefs as a research coordinator
The Grounded Theory
We present an overview of the grounded theory first before describing the findings
unique to the novice and experienced research coordinators. We use the grounded theory as
mechanism to (a) highlight the different insights among the experienced participants compared
to the novice participants and (b) to point out the relationships between characteristic variables,
such as the participant level of experience and qualitative data analysis results. The grounded
theory (see Figure 1) highlights the distinctively different and similar foci among the two
participating groups. For example, the novice research coordinators, perhaps owing to their
lesser number years on the job, focused considerably on how training could be improved as
evident in their theme of Making Programmatic Improvements. In contrast, the experienced
research coordinators discussed ways to address infrastructure and cultural issues, and how to
advance the field of research coordination via the theme Promoting leadership and advocacy.
They focused more deeply on personal change and strengthening their expertise via the theme,
Re-assessing their skills. Both participant groups shared in a discussion of the theme,
identifying preferences for instruction, and how the training seminar catalyzed changes in
perceptions of their roles, via the theme, Changing Self-Perceptions.
Three themes (Identifying preferences for instruction, Changing self-perceptions, and
Making programmatic improvements) and four subthemes (Naming favored modules,
Identifying topics not covered, Increasing confidence, and Impacting perceptions of ideal
coordinator) emerged from the analysis of the novice participants? focus group (see Table 2).
Identifying Preferences for Instruction: Participants described which approach to
instruction they liked best. They favored either the classroom instruction or a hybrid approach
-- the combination of online learning and classroom instruction. Jeff remarked that classroom
format ?addressed my needs better.? He found that peer interactions, opportunities to ask
questions and engage in extended discussion deepened his learning. Jane agreed. She opined
that interactions with the presenter were especially helpful for addressing particular questions.
Moreover, she observed that classroom learning activities could be more easily tailored to
individual learner needs. Ana agreed with Jeff and Jane. She pointed out that the classroom
format permitted participants an ?opportunity to ask, to share, and experience with other
coordinators.? Susan also enjoyed the classroom. As a new coordinator, she found that listening
to others? experiences and asking questions provided insight into ?something I might not think
Rosabel also found the classroom venue more valuable. She stated that was it ?more
adaptable? and allowed for elaboration especially in instances where ?you either felt confused
about [or] deficient? in particular content. She appreciated several classroom environment
characteristics including (a) the chance to ask questions, (b) use of varied methods of learning,
and (c) exposure to real life scenarios. Barbara also found the in-class model better. She pointed
out that the experts, the discussions, and peer interactions were a better approach to learning.
Ana liked the opportunity to observe processes and discover what was correct or incorrect.
Dale described how examples of budgeting allowed participants to observe an expert?s thought
processes in real time. ?Instead of seeing it done perfectly, we were able to see how someone
who has done that many times would correct her mistake.?. [We could] see how she justifies
the prices ?on the budget form, instead of just being given figures.? Ernesto felt that the
classroom interactions allowed participants to concentrate. He proffered that real time
interactions caused him to ponder, ?this is happening to me and how can we apply this??
Overall, the in-class setting fostered interactions that were impossible in the online venue,
which ultimately contextualized the reality of day to day work tasks.
Ana suggested that ?the combination of both [approaches] is more valuable.? She
recommended that requiring online first, followed by putting new knowledge into practice
within a face to face classroom environment was optimal. Jeff agreed and suggested ?a hybrid
of both online and in-person? was best. However, he also pointed out the unique benefits of
online learning whereby material could be presented at ?a much significantly lower expense
than having people together.? Benita concurred with Ana and Jeff that completing some
coursework and viewing the material before engaging in classroom learning was valuable.
Benita pointed out the classroom part was refreshing especially following the tedium of sitting
through CITI online training. In particular, she appreciated engaging in role play and asking
questions. Ernesto also liked the combination of classroom and online platforms. Ana
explained the benefits of having online learning in statistics prior to classroom training. She
described onsite training in statistics as overwhelming. However, she suggested that having an
introduction to terminology beforehand would have increased her knowledge base and allowed
her practice in class to be more efficient.
Naming favored modules: Most participants identified at least one module that they
found to be particularly valuable across the 2-day training. Susan, appreciated the session on
consenting. She liked the interactive teaching approach and asserted that it provided her with a
better understanding of why mirroring a patient is important. Stressing the interactivity of the
instructor?s approach, Jeff concurred. He liked the communications portion of training. While
acknowledging a lack of prior exposure, Jane favored learning about data management. She
reported the importance of quality assurance and quality control and ?making sure that you are
tracking everything you do, correctly.? Dale received a new perspective from a monitor outside
the academic setting. This session helped him appreciate the organization and structure of the
Case Report Form (CRF). Although at times contrary to his sense of logic, he acquired a better
understanding of regulatory processes. Barbara stated that the regulatory information, in
particular, such as doing her own budget was most beneficial. She also reported that the talks
on ethics and informed consent were ?really good.?
Identifying topics not covered: Four participants stated that there was one particular
content area that the training did not address. Jeff mentioned that good clinical practice and
training and human subjects? protection were covered quite sparsely. However, both were
covered in the online training prior to the face-to-face course. Rosabel wished trainers had
provided more information about study team participant interaction after receiving patient
consent. Ana was interested in learning more about study results so that while reading an article
she would understand ?how the results are presented.? Ana wondered how coordinators should
respond to patients who were reluctant to participate in a research study. She posed salient
questions with implications for recruitment. ?How do you approach them again? Do you
respect [when they tell you no] the first time?? She wanted to know if it was appropriate for
the research coordinator to approach the patient again. Jane, suggested that offering
coordinators an opportunity to learn how studies were conceived ?would be a valuable course?
although she was cognizant that this activity did not apply to everyone.
Changing Self-Perceptions: As a result of the training, participants began to change
their beliefs as clinical research coordinators in several ways such as (a) increasing professional
confidence; (b) understanding the qualities of the professional research coordinator and, (c)
discussing how beliefs were linked with their ideas about images of an ideal coordinator.
Ernesto suggested that newly acquired knowledge enhanced his understanding of the work that
people were doing, and suggested alternate ways to do the work. Seeing that ?this is really how
to do it? increased his self-confidence about the value of the work. He reasoned that, ?[Since]
I?m doing something ? important I need to take time doing it.? Barbara described herself as
a mentor, who could translate the information she received. Previously she has been a
preceptor. She saw the training as a way to broaden her mentoring role, and become ?a mini
mentor or preceptor for new coordinators.? She felt armed with useful information and looked
forward to bringing the information into her department. Although Barbara already felt
confident in her work, she stated that the course stressed ?the importance of training for
research coordinators, and emphasize[d] the importance for administrators to appreciate the
[significance]of it.? She believed that these actions would enhance her role as a mentor.
Increasing confidence: Participants reported that coordinator abilities improved, and
self-confidence increased due to their participation in training. Jeff said that getting in a group
and talking about the commonalities among their job roles and experiences made him realize,
?well, that?s really what I was doing, so now I feel good that I?ve gotten there.? While he was
developing a broader and contextualized appreciation of his work responsibilities, he gained
confidence in seeing how professional development opportunities could assist his growth. Jeff
believed that he would be able to see the fallacies more readily and use the training to enhance
his performance in data management. Barbara agreed with Jeff. She reported that she felt
validated. Despite ?not having a formal training [I realize] that I?m pretty much on the right
track.? As she discovered that she was mentoring correctly, her confidence in this arena
Rosabel had mixed feelings about changes in her self-confidence. She felt terrible
thinking about possible knowledge gaps, ?but the flipside of that was okay, I get it.? She came
to realize that she ?could do this.? Susan described feelings of loneliness as a novice
coordinator. However, she found that the group sharing enhanced her self-confidence. Ernesto
agreed that communication among colleagues enriched his self-confidence. Joan also reported
improved self-confidence, while pointing out that training information, like the ?epidemiology
lecture? ? reiterated things? that she knew.
Impacting perceptions of ideal coordinator: Participants identified the attributes that
characterized an ideal coordinator. They also discussed how their ideas of coordinator roles
changed as result of training. Joan suggested that time management skills were pivotal to
juggling multiple studies and for meeting deadlines. She also reported that skills related to
mapping out, making to-do lists, and ensuring that things were checked off daily were
necessary to staying organized. Dale mentioned that being organized was a top priority, as well
as being able ?to troubleshoot just on the fly.? For Dale, organization began at the point of
consenting. He explored potential actions in situations, when ?your transportation might not
show up and you?ve got a participant that you don?t want [to] drop out.? This circumstance
highlighted the importance of a quick and appropriate response to ensure the flow of the
Benita stated that being detail-oriented was an essential quality. If ?you miss one thing
and there?s like ten deviations? and then, the coordinator would be spending considerable time
filing all related forms rather than doing other work. She also stressed that an ideal research
coordinator had to be ?a people person? and know how to work with others. Barbara identified
communication skills and the ability to be comfortable as essential. She viewed a research
coordinator as the center of the project. ?The moment something could go wrong,? everyone
turns to the coordinator. Jane concurred and added that communication skills shaped the
relationships among the people involved in the research. Ana felt that the coordinator was an
ambassador of change. She recommended taking new information back to your office to ?share
[it] with the rest of the team.? She perceived an ideal coordinator as well-organized and having
interpersonal communication skills. Ana also perceived the coordinator to be a conduit to
providing new knowledge to the entire clinical research team.
Making Programmatic Improvements: This theme referred to participants?
suggestions for how training could be improved. Jane offered two suggestions. First, she
recommended leaving extra time for breakout sessions and developing guidelines to organize
discussions. Second, she proffered that discussion forums might encourage participants from
?different institutions and experience levels to talk to one another.? Rosabel reiterated the need
for leaving more time for participant interactions and sharing. Jeff felt rushed by the amount
of content covered in two days. He wanted the schedule to slow down so that participants would
have more time to interact with others. He also suggested breakout sessions to ?fill out some
of the gaps? while emphasizing that some of the content deserved much more time. He also
suggested hosting a week-long program or stretching it out over time as discreet segments in a
series of half days to give each module more attention. Providing flexible scheduling over time
with multiple sessions, in his opinion, would have offered more options.
Barbara opined that more time was needed for both online and in class platforms to
increase opportunities to ask questions. She felt that the two-day schedule lacked enough time.
Jane agreed and said that having half day training sessions offered greater flexibility in
scheduling. She recommended grouping topics more closely together. Barbara advocated for
keeping courses in close proximity to preserve context. However, unlike Barbara, Jane she
stressed the need to avoid the program from becoming piecemeal by stretching it out over time.
This was a particularly crucial consideration for new coordinators. Barbara echoed others?
sentiments that, ?having a real-life context? was pivotal to learning. Her feeling was this
training might have been too soon for new coordinators.
Jeff talked about splitting up the training. He suggested offering a basic training early,
allowing time in the field with an assignment to generate questions, and then bringing
participants back to the classroom for debriefing and further training. Dale liked this idea too,
but recommended offering it a few months after the starting date of new coordinators and then
adjusting the date to coincide with participants? needs. He stressed that participants needed
time to assimilate new knowledge. Ana suggested presenting material prior to class allowed an
opportunity for participants to read, prepare questions and understand what needed more
clarification. She liked the concept of pairing the less experienced and more experienced
coordinator together to foster implicit mentoring relationships. Jeff recommended delivering
material online and adding pre-tests to ensure that participants actually interacted with the
material. Susan thought that initially new coordinators should be provided with a context to
give them a better idea of what was expected and why.
IDENTIFYING PREFERENCES FOR
Recognizing most important training
Identifying topics not covered
Recommending training platform
Advocating for timing of training
PROMOTING LEADERSHIP AND
Dealing with conflict
Describing kind of teaching liked
Identifying essential topics
Describing topics not taught
Suggesting best type of professional
Suggesting when coordinators should have
professional development opportunities
Describing ways to increase understanding of
and respect for research coordinator work
within the institution and beyond
Responding to others' reluctance
Alterations in beliefs as a research coordinator
Articulating images of a research
Reporting enhanced abilities
Revising ideas of coordinator roles
Evaluating personal abilities as a research
Four themes (Identifying preferences for instruction, Promoting leadership and
advocacy, Changing self-perceptions, and Re-assessing skills) and seven subthemes
(Recognizing most important training content, Identifying topics not covered, Recommending
training platform, Advocating for timing of training, Dealing with conflict, Increasing
confidence, and Articulating images of a research coordinator) emerged from the analysis of
the experienced participants? focus group (see Table 3).
Identifying Preferences for Instruction: Experienced participants preferred the
classroom experience over the online module. Janie said the in-class provided a forum for
asking questions and seeking clarification. For Janie, the face to face classroom setting ?often
inspire[d] conversation and sharing." Imparting experiences introduced new ideas and
reinforced knowledge. This practice was not restricted to the classroom because it had the
potential to extend outside of classroom. Marcy concurred with Janie that the classroom
encouraged participant interactions and reinforced what she already knew. This observation
was aligned with others who perceived classroom learning as a refresher of knowledge. Marcy
also enjoyed the classroom interactions and concurred with Maria?s expressed preference for
face to face teaching because it provided an opportunity ?to ask questions and get direct
answers right away.? A preference for the classroom contrasted with the on-line learning,
which while valued, was not preferred. Of online, Janie pointed out that, ?often they completed
the modules because they were required to do so. However, she reported that, ?I?m not sure
that we?re really paying as much attention to the details and the key facts.? Marcy was glad she
repeated the entire course again online after having completed it in the distant past. Janie also
like the interactive nature of practicing consenting with her novice staff. It allowed them to see
how skilled they were and noted that, ?It was just a great way to reinforce our working
Recognizing most important training content: Several experienced participants found
value in the training although they considered some topics to be more essential than others.
Amy thought the section on Communication was one of the most important. Communication,
presented in the context of conducting informed consent, revealed a ubiquitous procedure in a
new light. After listening to the discussions across topic areas, she realized that communication
concepts applied across other areas, like working with sponsors and source documentation.
Herminie also remarked about the Communication content. While interacting with and
discussing the protocol, she explained that that the coordinator should be expected to examine
and interpret protocol components to ensure compliance with directions. Janie pointed out that
the one best practice she learned during training was to create a protocol checklist to guide
communication and direct the project.
Identifying topics not covered: The absence of discussion around Investigational
Medical Devices was apparent to a several participants. Herminie and Maria mentioned there
were no discussions of regulations or references to these devices and emphasized its importance
as a separate skill set. Amy also remarked on the absence of coverage on devices. She also
observed that there was nothing covered related to writing informed consents. She added that
there was a lack of review on documentation and grading of Adverse Events. Roberto noticed
inadequate coverage in the informed consent material on pediatric and special populations.
Janie added that the concepts of compliance with relation to ?understanding what is [a] standard
of care, what is not [a] standard of care? also were not covered.
Recommending training platform: There was a unanimous consensus, despite a
majority preference for the classroom experience, that a combination of online and classroom
was advisable. Amy suggested a combination so that she could go back and reference the
information. She stressed the importance of completing online trainings beforehand because it
provided a foundation.
Herminie also recommended the online and in person training while pointing out that
the classroom format offered ?a different perspective [where you] can interact with others and
learn, or listen [to] their experience.? Janie agreed that a combination of different approaches
which addressed different learning styles was best. She pointed out classroom learning offered
an ?opportunity for confirmation of what you?ve learned? while seeking the wisdom of an
instructor and peers.
Advocating for timing of training: Marcy encouraged that online training to be
completed as close as possible to the classroom component. Amy recommended developing a
basic foundation of knowledge online first and engaging in classroom learning to acquire more
in-depth. She recommended breaking the classroom course up into two discreet courses to
minimize overload. Janie felt new coordinators would not benefit much from early interaction
due to a lack of experience and recommended ?phasing it in over time.? Amy valued obtaining
baseline information early to inform subsequent experience. Marcy recommended sponsoring
a novice coordinator at the training. She suggested that only after a significant period of gaining
experience would the novice be able to assimilate some of the training offered in the two-day
intensive. Beth had taken much of mandatory training, but ?felt like a lot of the live interactive
training was much more beneficial to her as a coordinator at 14 months than it might?ve been
Promoting Leadership and Advocacy: This group of participants, by nature of their
experience, were involved in leadership and advocacy to varying degrees. During the training,
Janie, an administrator, realized that her unit was weak in areas that had ramifications for how
resources were utilized. She recognized areas where she could change her coordinators?
practice. In particular, she felt that engaging her staff earlier in the development process would
help them ?begin to prepare a little sooner." Maria linked leadership and advocacy to
communication. She observed that it was incumbent upon individual coordinators to
communicate the value of research coordinator work within the institution and beyond. For
Maria, this process entailed finding a common cause and communicating the intrinsic value of
the research coordinator role to overcome a ?very deep resentment? in the clinical areas that
interfaced with research.
Dealing with conflict: Maria explained that sometimes nurses and therapists who
seemingly cared about the patients thought that research coordinators were experimenting with
the patients. As a result, coordinators were compelled to take the time to explain why
translational research was being conducted. Unfortunately, co-worker ignorance was an
impediment to patient recruitment. As Maria opined ?just a simple comment to the parent?
from co-workers caused potential recruits to take a very negative view of the research study.
Perhaps more conversation and team meetings were needed to clarify the role of research
coordinators. Such meetings might reaffirm that all health employees work for a common
purpose. Unclear from this portion of the group was what co-workers Maria referring to such
as staff, nurses, or other healthcare workers.
Herminie identified another topic of concern -- how to address the undervaluing of the
coordinator?s role and professional stature. She pointed out that participants come for trainings,
being edified and raised up in self-esteem, but then return to a work setting only to find that
leadership does not understand their re-envisioned role. She suggested that there had to be a
change in ?the mentality? of the leadership. Roberto agreed and recommended that a ?better
culture of understanding why? research procedures are often very rigid in their execution were
needed. He cited timed blood draws as an example and stated that cultural grounding ?on why
we?re doing this that way? would alleviate angst and confusion.
One of the training goals was to enhance participants? willingness to speak up. The
majority of research coordinators who took part in this FG achieved this goal. Maria explained
that she could now express herself better. Additionally, she specified a need to change her
communication with the sponsors of studies she coordinated. After training, she felt
empowered and stated, ?I believe now that coordinators have more power than I thought
before.? The training caused participants to see the purposefulness of their roles in a new light.
They discussed ways to improve their own and fellow study coordinators? skills. Improved
practice held the potential for impact on resource utilization, to foster better organization with
greater attention to project details and to avert extra work.
Changing Self-Perceptions: Participants reported how beliefs about the work of a
research coordinator changed as a result of the training. Charisse and Maria reported feeling
happier about their jobs. Maria discovered that her job was more important than she previously
thought. Charisse now appreciated that her work was something very good and planned to
?implement whatever I learned here? when she returned to her campus. Maria also felt more
confident and was satisfied just by knowing she was? not doing anything wrong.?
During training, Janie and Maria learned that there were aspects of their job that they
needed to do better. Janie confessed that her group lacked strength in some areas that impacted
resource utilization. She opined that she could improve as an administrator and that there were
areas where she could influence improvement in her coordinators? practices. By doing so, she
suggested that the research coordinators could make enhanced choices earlier in their studies.
Maria recognized that she needed to improve communication with the research sponsor. She
explained that her institution?s studies needed to adhere to certain conditions but that physicians
did not always comply. She surmised that by discussing this issue with physicians earlier rather
than waiting that they could increase patient enrollment. Janie explained the importance of
drilling down on the type of information needed for source documentation. To minimize
queries, she decided to meet with her team prior to budget negotiation and help ensure that
everyone was capturing the appropriate data.
Maria?s sense of belonging to a career was enhanced as a result of the classroom
training. She also felt more empowered. No longer was she going to simply accept others?
resistance or lack of knowledge about research coordinator work. She felt that she had the
prerogative to communicate with others especially staff and principal investigators, about the
importance of strictly following a protocol.
Janie pointed out that one of the best practices she garnered from the classroom was a
checklist that helped coordinators use protocols so that they could locate the necessary data
that would be used to generate reports. She was grateful for the opportunity to learn from others.
She also appreciated acquiring new practices that she could implement at her institution. As
she surmised, ?there?s no price that you can put on that opportunity.?
Increasing confidence: Discussions about self-confidence revolved around exploring
enhanced abilities. Participants described ways in which their abilities to perform as a research
coordinator were enhanced. Maria shared her feelings about her job, saying that she found her
job being more important than she previously believed and said, ?I am happier? I was kind of
getting depressed before, but not anymore.? She also gained insight that solidified that she
fulfilled her job responsibilities. Charisse also reported gaining more confidence and stated that
she was doing something good, and had become a happier person. She planned to implement
new knowledge in her work. Janie stated that her previous knowledge was reaffirmed. She
described how training helped her develop a rationale for administrative decisions. Amy also
saw the training as a ?good refresher.? Although her confidence remained unchanged, she
enjoyed hearing different perspectives from other participants.
Marcy described feeling reinforced about the budget and that she was able to ?tackle
these things one at a time.? Roberto expressed similar perspectives. He broadened his view and
understanding of the budgeting processes and obtained concrete behavioral strategies to guide
his actions ?in situations where you don?t necessarily know how.? Amy summed up the
reflections of her colleagues by saying, ?I think it?s always nice to get that confirmation that?,
you?re on the right track, because it can get very overwhelming with all the little details that
you have to know.? Overall, participants received validation and confirmation of the
rightdoing. Along with gaining new knowledge about their job, they felt that their confidence was
bolstered and that their abilities were reinforced.
Articulating images of a research coordinator: During the course of the classroom
training participants realized the vitality of their role in the research enterprise. Despite Maria?s
recognition of some very deep resentment within the clinical enterprise, she and others
discovered that in many ways this circumstance was directly related to the quality of their work.
They came to understand that they could become advocates of professionalizing research
coordination and could teach others why their role was essential. Janie felt that the class setting
encouraged participants to ask questions about things where they had doubts. She also stated
that it inspired conversation and sharing experiences where they could promote change in their
institutions about how others viewed their role. Janie also thought that classroom sharing
allowed participants to acquire a portfolio of best practices to take back to their home
institutions. Participants began to appreciate that they were the nexus of the research enterprise.
Roberto wished that there was a better culture of understanding about the nature of clinical
research. However, like the others, he began to recognize their responsibility in changing the
institutional culture and researchers? perceptions. Charisse stated the classroom sessions helped
her realize that she was doing some regulatory aspects of her job incorrectly. Now that she had
new information she planned to go back and adjust everything that needed correction.
Re-Assessing Skills: During the FG, participants reflected upon their own skills as a
research coordinator. Owing to the new knowledge acquired, participants were positioned to
anticipate some things differently than they did prior to the training. Marcy confessed that there
were some administrative processes that she had been hesitant to implement. She described
how the trainer?s logical framework helped her acquire new tools and skills for working on the
budget. Following the training, she felt that she could more easily ?tackle these things one at a
Janie described several areas where she ascribed her own weaknesses and was looking
forward to changing her practice and the practice of her coordinators such as (a) evaluating
studies upfront, (b) identifying certain aspects of the study, and (c) being prepared for the first
patient. These actions could help her, and her team, avoid multiple queries. She began to
question her particular group?s practices related to data entry. Janie asked, ?Why weren?t we
capturing that data in the way that they wanted?? She found that there was a discrepancy
between what the coordinators were asked to do while recording standing blood pressure versus
a sitting blood pressure, or when the blood pressure had to be taken five minutes before the
patient was given the drug. Failure to follow the standard practice, meant that her team had
ignored important protocol details. As a result, they had to do additional work to resolve these
Roberto explained that because of new understanding about budget negotiation he had
a better idea of where to put certain elements into the budget. He also described how the
classroom sessions reinforced daily activities that research coordinators do. He felt that he was
able to do a better job developing new protocols.
Overall, the participants indicated a clear preference for a combination of onsite
classroom instruction in real time along with online learning. However, this preference was
qualified by the nature of the taught material, timing of training and level of expertise.
Participants suggested that they be required to complete online learning prior to onsite
classroom training for certain content, such as statistics. Providing participants with a primer
of essential statistical terms prior to the face-to-face class might have aided their understanding.
However, since the statistical competency required for coordinators is rudimentary, taking a
semester-length online course in statistics is unnecessary. For other content such as developing
a budget and learning how to obtain informed consent, they advised that their first exposure
should be onsite classroom instruction. They pointed out that training opportunities, whether
online or onsite classroom be tailored according to the longevity, or length of time as a research
coordinator. These findings highlight that not all learning environments meet the needs of all
As clinical research leadership searches for the penultimate solution directed at
ensuring that all coordinators are trained, the study findings provide some guidance.
Curriculum developers need to be mindful of the audience for whom instruction is intended.
Perhaps they will need to create a different menu of options for audiences, rather than assume
that a single set of modules or types of training platforms can satisfy learners? needs.
Participants recommended specific ideas relative to when training is offered such as (a) offering
training over time, (b) providing baseline information at the onset of employment, and (c)
offering training modules only after a significant period of work experience. These suggestions
highlight the importance of planning training alongside the skills obtained during the early
years (up to ten) of being a research coordinator and later (over ten) when a coordinator was
likely more skilled. Attention to who is providing the training will also need to be considered.
The authors acknowledge that an enthusiastic presenter who used interactive learning activities
is more likely to entice most participants compared to a presenter who simply delivers a lecture
about the content.
In considering the findings, identifying preferences for instruction and the kinds of
teaching preferred there may be a situational bias. The FGs were convened immediately after
two days of classroom experience while the comparative online experience was received at
variable intervals up to one month prior. Participants expressed a clear preference for what
might be characterized as a ?socially mediated experience,? represented as in-class and
liveinteractive or more directly, person-to-person training. This ?in-the-presence-of? instructors,
teachers and other students, allowed participants to ask questions and promote conversation.
The value placed on sharing experiences points to a social phenomenological relation between
experience and experience, or rather what as RD Laing coined, a field of ?inter-experience?
(Laing, 1968, p. 2)
. As shown in this study, inter-experience fostered the ability to socially
engage with others, to form meaningful, positive mentoring and to build networks in ways that
transcended the implicit limitations of online training with its sociotechnical context of resting
in one?s intra-experience.
On-line learning was often characterized as a chore. Although participants took online
modules, they did not necessarily pay attention to either the details or the facts. At times, they
simply went through the motions of completing modules. The live training emphasized a
degree of social reinforcement that was not available online, especially given the
noninteractivity that characterizes the CITI program.
Clinical Research Coordination is a complicated social activity. How individuals make
sense of personal and group behavior is socially constructed in ways that
describe as integration of group norms, characteristics, values, and ideals into one?s self.
Reinforcement in observing was demonstrated in particular by participant?s characterization of
their visceral response to the role play activities that ensued during the informed consent. Social
reinforcement plays a crucial role in conveying the values essential to the responsible conduct
of research. The group process may also have solidified emergent bonds among individuals
The use of qualitative methods and a grounded theory approach in particular revealed
participants? multilayered experiences and responses to two very different learning platforms.
The use of a codebook offers researchers another method that can be reliably implemented
when care is taken by the research team to corroborate findings at each step of the analytical
process. Qualitative inquiry illustrated the nuanced responses and explication of participant
experiences that otherwise remain unknown. The online platform dedicated to knowledge
acquisition occurred in an environment that lacked opportunity for bi-directional interactions.
It offered dissemination of information in a one-way transmission from program to learner.
The in-class, on-site learning, offered interactions, contextualized by the give and take between
instructors and peers. This learning environment permitted asking questions, sharing
experiences and role-playing, while allowing confirmation of professional roles and identities.
This approach also fostered an application of theory to practice with real time clarification and
opportunities to see how concepts and thinking were modelled by instructors. Clearly, this level
of insight would have been unavailable from an analysis of survey results. The novelty of FGs
offers a deepened appreciation of participant experiences that pointed out that training
preference is not a binary. The FG experience fostered an assimilation of learning among the
group, while accelerating self-realization and promoting new meaning among individuals. The
situational, contextual and learner centric phenomena revealed in this study might provide
guidance in the development of future training. Program developers, however, are advised to
carefully consider learners? needs in relationship to type of skill, level of experiences, timing
of training, and multiple pathways for achieving those desired outcomes.
The training played a significant role in changing participants? self-perceptions by
validating their experiences. Research coordinators obtained an education-based framework
for the variety of work related actions they were performing. The anticipation anxiety they have
felt prior to the training decreased, while they became more confident after learning that they
were performing their jobs in an appropriate fashion. This growing confidence led to being
proactive in planning future steps in their professional development and the ability to recognize
knowledge gaps. The training had an impact on coordinators? leadership abilities. While
discussing the ideal research coordinator, they vocalized their zone of proximal development
in the leadership realm.
One additional area of interest holds implications for future study. During discussion
about feeling undermined by co-workers it was difficult to discern if the referent group was
nurses or other healthcare workers. However, in Jones et al., they point out the need for further
research and policy statements on the delegation and supervision of clinical research activities
from the PIs to clinical research nurses and other clinical research staff
(Jones, Hastings, &
. In particular, they recommend clarifying the scope of practice among RNs and
non-nurse research personnel. Titles including, Clinical Research Associate (CRA) or Clinical
Research Coordinator (CRC), applied to nurses in clinical research are also used for non-nurses
who coordinate or support clinical research
(Association of Clinical Research Professionals,
2017a, 2017b; Hastings, Fisher, & McCabe, 2012)
. Certification for these titles do not require
registered nurse licensure. Since researchers pointed out long-standing role conflict between
nurse and non-nurses who coordinate or support clinical research, this area might warrant
Limitations of the study were the use of one FG per experiential level. The overall
findings are not generalizable. They are contextualized by the individuals who participated and
are situated at a particular point in time. The questions asked are necessarily restricted by
available response time, to permit individual participants an opportunity to answer each
question. The methodological rigor of this study rests with verifiability, creditability,
dependability, and transferability of findings, processes that are synonymous with validity,
reliability, internal validity, and generalizability. Missing from this study is an assessment of
the actual learning that occurred during the workshop. A pretest and a posttest based upon the
actual content of the workshop would enable a quantitative comparison to the qualitative
expressions in the paper.
Focus groups with novice and experienced research coordinators revealed their
preference for a combination of onsite classroom instruction in real time along with online
learning. This preference was qualified by the nature of the taught material, timing of training
and level of expertise. Study findings highlight that not all learning environments meet
participants? learning needs. Clinical Research Coordination is a complicated social activity.
How individuals make sense of personal and group behavior is socially constructed.
Qualitative inquiry illustrated the nuanced responses and explication of participant experiences
that otherwise remain unknown. The findings advise that optimal training be tailored to
participants? needs while considering their work experience, how technology can aid learning
and offering content that is most urgently needed.
Linda S. Behar-Horenstein, PhD is Distinguished Teaching Scholar & Professor in the
Colleges of Dentistry, Education, & Pharmacy, Director, CTSI Educational Development &
Evaluation, and Co-Director, HRSA Faculty Development in Dentistry at the University of
Florida. Correspondence regarding this article can be addressed directly to: .
JoNell Efantis Potter, PhD is Associate Professor, Department of
ObstetricsGynecology & Pediatrics, Director, Division of Research & Special Projects, Chief, Women's
HIV Service, Vice-Chair IRB Committee C, Human Subjects Research Office, Co-Director,
Alianza Program, Miami Clinical & Translational Science Institute, and Associate Director,
Clinical Translational Research Center in the Miller School of Medicine at the University of
Miami. Correspondence regarding this article can also be addressed directly to:
Alena Prikhidko is a Doctoral Candidate in the College of Education at the University
of Florida. Correspondence regarding this article can also be addressed directly to:
Stephanie Swords, MA, CCRP is the Program Director - Study Coordinator
Apprenticeship and Mentoring Program (SCAMP) & Research Coordinator Support Service
(RCSS) at the Johns Hopkins University's Institute for Clinical and Translational Research.
Correspondence regarding this article can also be addressed directly to: .
Stephen Sonstein is Professor and Program Director for Clinical Research
Administration at the Eastern Michigan University's School of Health Sciences.
Correspondence regarding this article can also be addressed directly to: .
H. Robert Kolb, RN BS CCRC is the Assistant Director for the Clinical Research
Translational Workforce Directorate and Research Participant Advocate / Consultant for
Regulatory Knowledge, Research Support and Service Center at the University of Florida'
CTSI. Correspondence regarding this article can also be addressed directly to: .
Research reported in this publication was supported by the University of Florida
Clinical and Translational Science Institute, which is supported in part by the NIH National
Center for Advancing Translational Sciences under award number UL1TR001427. The content
is solely the responsibility of the authors and does not necessarily represent the official views
of the National Institutes of Health.
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