The Competency of Clinical Research Coordinators: The Importance of Education and Experience

Hornung, Carlton A.; Kerr, Jared; Gluck, William; Jones, Caleb

doi:10.1007/s43441-021-00320-w

Cited by 7 publications

(7 citation statements)

References 9 publications

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“…Positive environments are created through staff being both professional as well as warm and approachable, and by making efforts to show participants that they are appreciated and valued (for example by offering them coffee or lunch). These findings are in line with previous studies on clinical trial organization, in which educated or experienced staff was found highly relevant for the execution of the growing complexity of clinical trial execution [35,36], In our study, there was considerable variation in the positive and negative aspects of trial participation and optimal trial design. However, all participants mentioned the importance of a caring and supporting environment and an empathic research staff.…”

Section: Discussionsupporting

confidence: 92%

Experiences of and recommendations on clinical trial design in Alzheimer’s disease from the participant’s point of view: a mixed-methods study in two clinical trial centers in the Netherlands

et al. 2023

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Introduction In the context of the development of pharmaceutical interventions, expectations and experiences of participants are essential. Their insights may be particularly helpful to address the challenges of recruiting and retaining participants for Alzheimer’s disease (AD) clinical trials. We examined clinical trial participants’ experiences to optimize trial design in Alzheimer’s disease (AD). Method In this mixed-methods study, we included adults who participated in sponsor-initiated AD trials at Brain Research Center, a clinical trial organization in the Netherlands. Participants (N = 71, age 69 ± 6.5, 54%F, 19 cognitively normal (CN), 19 mild cognitive impairment (MCI), and 33 AD dementia) first completed an online survey. Diagnostic group differences were investigated using chi-square tests or one-way ANOVAs. Next, a subsample (N = 12; 8 = CN, 4 = MCI) participated in focus groups to gain in-depth insight into their opinions on optimizing trial design from a participants’ point of view. Audio recordings from focus group interviews were transcribed verbatim and analyzed by thematic content analysis by two independent researchers. Results Most reported motives for enrolment included “to benefit future generations” (89%), followed by “for science” (66%) and “better monitoring” (42%). Frequent suggestions for increasing willingness to participate included a smaller chance to receive placebo (n = 38, 54%), shorter travel times (n = 27, 38%), and sharing individual results of different assessments (n = 57, 80%), as well as receiving trial results (n = 52, 73). Highest visual analogue burden scores (0–100) were found for the lumbar puncture (M = 47.2, SD = 38.2) and cognitive assessments (M = 27.2, SD = 25.7). Results did not differ between diagnostic groups, nor between patient and caregiver participants (all p-values>.05). Two additional themes emerged from the focus groups: “trial design,” such as follow-up visit(s) after participating, and “trial center,” including the relevance of a professional and empathic staff. Conclusion Relevant factors include expectation management and careful planning of high-burden assessments, provision of individual feedback, and prioritizing professionalism and empathy throughout conduct of the trial. Our findings provide insight into participants’ priorities to increase willingness to participate and can be used to optimize trial success.

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Section: Discussionsupporting

confidence: 92%

Experiences of and recommendations on clinical trial design in Alzheimer’s disease from the participant’s point of view: a mixed-methods study in two clinical trial centers in the Netherlands

et al. 2023

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“…These are very much inter‐related. Hornung et al 14 reported that the degree of self‐perceived confidence in performance of advanced tasks, such as regulatory affairs, in recent graduates of formal CRC training programs was equivalent to as much as 5 years of experience in a research‐intensive CTSA and 10 years of experience in community settings. In the Clinical Research Associate Retention Study, 15 lack of professional development was associated with greater likelihood of attrition among associates.…”

Section: Program Developmentmentioning

confidence: 99%

Clinical research resource support for off‐site research coordinators in intensive and specialty care units

Castaneda

Marder

Kashyap

et al. 2023

Clinical Translational Sci

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Clinical Research Coordinators (CRCs) are vital collaborators in a clinical research project. They often are the primary liaisons between investigators and human participants in studies and are involved in every aspect of many protocols, including participant recruitment, care (both usual medical care and specific study‐related monitoring and procedures), data collection, specimen processing, and follow‐up. The Clinical Translational Science Award program, which was created by the National Institutes of Health in 2006, has significantly expanded the venues in which Clinical Research Resource (CRR) – based CRCs are embedded. CRCs functioning in these areas, outside of the research‐focused in‐patient environment of the CRR, are designated as “off‐site” CRCs. Many of these locations, such as intensive care units and emergency departments, require that CRCs interact regularly with healthcare providers whose primary functions are focused on providing optimal patient care rather than research and often involving very complex patients. These off‐site CRCs require additional training and support outside of the usual research‐oriented environment of the CRR. They are required to function within the context of the patient‐care team while fostering implementation of collaborative research. This is a description of such a program specifically geared to off‐site CRCs with the goal of enhancing the quality of research and experiences of CRCs.

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“…Furthermore, assessment of competency acquisition is limited. A short self-assessment for CRP clinical trial competence has been developed and shows potential as pre-test and post-test measures for staff undergoing training, or perhaps as a self-assessment tool during periodic needs assessments for CE [24][25][26]. Additionally, the value of CE should be coupled with evaluation of methods and outcomes [27].…”

Section: Competency-based Education For Crpsmentioning

confidence: 99%

Academic medical center clinical research professional workforce: Part 2 – Issues in staff onboarding and professional development

Knapke

Jenkerson

Tsao

et al. 2022

J. Clin. Trans. Sci.

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Background: Defining key barriers to the development of a well-trained clinical research professional (CRP) workforce is an essential first step in identifying solutions for successful CRP onboarding, training, and competency development, which will enhance quality across the clinical and translational research enterprise. This study aimed to summarize barriers and best practices at academic medical centers related to effective CRP onboarding, training, professional development, identify challenges with the assessment of and mentoring for CRP competency growth, and describe opportunities to improve training and professionalization for the CRP career pathway. Materials/Methods: Qualitative data from a series of Un-Meeting breakout sessions and open-text survey questions were analyzed to explore the complex issues involved when developing high-quality onboarding and continuing education opportunities for CRPs at academic medical centers. Results: Results suggest there are several barriers to training the CRP workforce, including balancing foundational onboarding with role-based training, managing logistical challenges and institutional contexts, identifying/enlisting institutional champions, assessing competency, and providing high-quality mentorship. Several of these themes are interrelated. Two universal threads present throughout all themes are the need for effective communication and the need to improve professionalization of the CRP career pathway. Conclusion: Few institutions have solved all the issues related to training a competent and adaptable CRP workforce, although some have addressed one or more. We applied a socio-technical lens to illustrate our findings and the need for NCATS-funded academic medical centers to work collaboratively within and across institutions to overcome training barriers and support a vital, well-qualified workforce and present several exemplars from the field to help attain this goal.

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The Competency of Clinical Research Coordinators: The Importance of Education and Experience

Cited by 7 publications

References 9 publications

Experiences of and recommendations on clinical trial design in Alzheimer’s disease from the participant’s point of view: a mixed-methods study in two clinical trial centers in the Netherlands

Experiences of and recommendations on clinical trial design in Alzheimer’s disease from the participant’s point of view: a mixed-methods study in two clinical trial centers in the Netherlands

Clinical research resource support for off‐site research coordinators in intensive and specialty care units

Academic medical center clinical research professional workforce: Part 2 – Issues in staff onboarding and professional development

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