Self-assessed Competencies of Clinical Research Professionals and Recommendations for Further Education and Training

Sonstein, Stephen A.; Samuels, Elias; Aldinger, Carmen; White, Sarah; Bierer, Barbara E.

doi:10.1007/s43441-022-00395-z

Cited by 7 publications

(5 citation statements)

References 30 publications

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“…The CRC workforce reported a relatively lower level of perceived competency in Domain 3, investigational products development and regulation, and Domain 1scientific concepts and research designwhile they perceived relatively higher competency in Domain 5study and site management. A similar competency pattern among CRCs was also found in a recent study [33].…”

Section: Number Of Visits To Empactsupporting

confidence: 88%

Conceptualization, development, and early dissemination of eMPACT^TM: A competency-based career navigation system for translational research professionals

Choi,

Kwon,

Rojewski

et al. 2023

J. Clin. Trans. Sci.

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Introduction: Purposeful training and ongoing career support are necessary to meet the evolving and expanding roles of clinical research professionals (CRP). To address the training and employment needs of clinical research coordinators (CRCs), one of the largest sectors of the CRP workforce, we designed, developed, and implemented an online career navigation system, eMPACT TM (eMpowering Purposeful Advancement of Careers and Training). Methods: A design-based research method was employed as an overarching approach that frames iterative design, development, and implementation of educational interventions. The five major phases of this projectconceptualization, task analysis for measurement development, algorithms development, algorithms validation, and system evaluationpresented specific goals and relevant methods. Results: The results reported how the eMPACT TM system was conceptualized, developed, and validated. The system allowed CRCs to navigate tailored training and job opportunities by completing their task competencies and career goals. The data sets could, in turn, support employees' and training coordinators' informed decisions about organizational training needs and recruitment. The early dissemination results showed steady growth in registered CRCs and diversity in users' ethnicity and job levels. Conclusions: The eMPACT TM service showed the possibility of supporting CRCs' individual career advancement and organizational workforce enhancement and diversity. Long-term research is needed to evaluate its impact on CRC workforce development, explore key factors influencing workforce sustainability, and expand eMPACT TM service to other CRP sectors.

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Section: Number Of Visits To Empactsupporting

confidence: 88%

Conceptualization, development, and early dissemination of eMPACT^TM: A competency-based career navigation system for translational research professionals

Choi,

Kwon,

Rojewski

et al. 2023

J. Clin. Trans. Sci.

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“…The assessment tool had high Cronbach’s alpha demonstrating a high level of internal consistency. Moreover, these data from our program demonstrate acquisition of competence in the areas of scientific concepts and research design and investigational product development, areas that have been shown to be deficits in the field ( 20 ).…”

Section: Discussionmentioning

confidence: 78%

“…research(18, 19). Our study presents a potential program evaluation tool for usefulness in assessing whether our competency-based academic program is meeting the JTF Competency needs of students targeting clinical research professional roles.…”

mentioning

confidence: 99%

The competency index for clinical research professionals: a potential tool for competency-based clinical research academic program evaluation

Jones,

Liu,

Hornung

et al. 2024

Front. Med.

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BackgroundAccreditation of graduate academic programs in clinical research requires demonstration of program achievement of Joint Task Force for Clinical Trial Competence-based standards. Evaluation of graduate programs include enrollment, student grades, skills-based outcomes, and completion rates, in addition to other measures. Standardized measures of competence would be useful.MethodsWe used the Competency Index for Clinical Research Professionals (CICRP), in a separate-sample pretest-posttest study to measure self-confidence or self-efficacy in clinical research competency comparing cohorts of students entering and completing a master’s degree program in clinical research across three semesters (summer 2021 – spring 2022). CICRP is a 20-item Likert scale questionnaire (0 = Not at all confident; 10 = extremely confident).ResultsThe study sample of 110 students (54 in the entry course, 56 in the exit course) showed overall 80.9% entered the program with only a baccalaureate degree and 55.5% had no prior experience in managing clinical trial research. Cronbach alpha for the instrument showed a high level of content validity (range 0.93–0.98). Median CICRP item rating range at entry was [1, 6] and at exit [7, 10]. Mean CICRP total score (sum of 20 items) at entry was 72.7 (SD 41.9) vs. 167.0 (SD 21.1) at exit (p < 0.001). Mean total score at program entry increased with increasing years of clinical trial management experience but attenuated at program exit.ConclusionThis is the first use of the CICRP for academic program evaluation. The CICRP may be a useful tool for competency-based academic program evaluation, in addition to other measures of program excellence.

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“…Professionalizing the workforce is a strategic goal for the clinical research enterprise as shortages in the workforce threaten operations and clinical trial progress ( Freel et al, 2023 ). The basic content for clinical research professional academic curricula, training curricula, job titles, professional advancement, ePortfolios, professional certification, research, team science competencies for CRPs, competency assessments, and international applications are all influenced by the adoption and application of the JTF Framework ( Association of Clinical Research Professionals, 2018 ; Stonier et al, 2020 ; Ivey, 2021 ; Jones et al, 2021 ; Society of Clinical Research Associates ; Sonstein et al, 2022b ; Glaettli et al, 2022 ; Ibrahim et al, 2022 ; Mendell et al, 2023 ). A CTSA working group has conducted a leveled approach to define CRP team science competencies, which provides more granularity to JTF domains 7 and 8 covering Leadership, Professionalism, Communication, and Teamwork ( Mendell et al, 2023 ).…”

Section: Discussionmentioning

confidence: 99%

Education and training of clinical research professionals and the evolution of the Joint Task Force for Clinical Trial Competency

Sonstein,

Silva,

Jones

et al. 2024

Front. Pharmacol.

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Clinical research professionals play a critical role in the design, conduct, and oversight of clinical trials, and they must have the knowledge, skills, and abilities to ensure that trials are conducted ethically, safely, and in accordance with regulatory requirements. As clinical research has evolved from being a necessary activity for the development and regulatory approval of new medicines to an accredited academic discipline and, more recently, to a globally recognized profession, the methods of education and training of professionals have also evolved. Initially, on-the-job informal coaching and specialized training organizations led to formalized and accredited academic degree programs and, more recently, to international competency standards and competency maintenance through continuous professional development. The Joint Task Force (JTF) for Clinical Trial Competency is a multidisciplinary, international group of experts who came together to aggregate and refine competency standards for clinical research professionals, first published in 2014. The 8 domains and 49 specific core competencies of the JTF Framework have become a globally recognized standard upon which education and training programs, role descriptions, and upward mobility criteria for professionals are now based. The JTF meets regularly and, through its workgroups, continues to evolve in response to the changing needs of the profession. The JTF is committed to continuous improvement to ensure that clinical research professionals have the competence necessary to conduct safe, ethical, and high-quality clinical research.

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Self-assessed Competencies of Clinical Research Professionals and Recommendations for Further Education and Training

Cited by 7 publications

References 30 publications

Conceptualization, development, and early dissemination of eMPACT^TM: A competency-based career navigation system for translational research professionals

Conceptualization, development, and early dissemination of eMPACT^TM: A competency-based career navigation system for translational research professionals

The competency index for clinical research professionals: a potential tool for competency-based clinical research academic program evaluation

Education and training of clinical research professionals and the evolution of the Joint Task Force for Clinical Trial Competency

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Self-assessed Competencies of Clinical Research Professionals and Recommendations for Further Education and Training

Cited by 7 publications

References 30 publications

Conceptualization, development, and early dissemination of eMPACTTM: A competency-based career navigation system for translational research professionals

Conceptualization, development, and early dissemination of eMPACTTM: A competency-based career navigation system for translational research professionals

The competency index for clinical research professionals: a potential tool for competency-based clinical research academic program evaluation

Education and training of clinical research professionals and the evolution of the Joint Task Force for Clinical Trial Competency

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Product

Resources

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Conceptualization, development, and early dissemination of eMPACT^TM: A competency-based career navigation system for translational research professionals

Conceptualization, development, and early dissemination of eMPACT^TM: A competency-based career navigation system for translational research professionals