Education and training of clinical and translational study investigators and research coordinators: A competency-based approach

Calvin-Naylor, Nancy; Jones, Carolynn Thomas; Wartak, Michelle M.; Blackwell, Karen; Davis, Jonathan M.; Divecha, Ruthvick; Ellerbeck, Edward F.; Kieburtz, Karl; Koziel, Margaret J.; Luzuriaga, Katherine; Maddox, Jennifer; Needler, Nancy A.; Murphy, Susan L.; Pemberton, Kieran; Radovich, Catherine; Rubinstein, Eric; Selker, Harry P.; Tenaerts, Pamela; Unsworth, Kelly; Wilson, Kay; Wright, Jonelle E.; Barohn, Richard J.; Shanley, Thomas P.

doi:10.1017/cts.2016.2

Cited by 57 publications

(62 citation statements)

References 10 publications

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“…Professional groups elsewhere in clinical research are working to define the roles and competencies of individuals working in specific areas, including physician investigators, nurses, investigational site staff as well as other professions involved in regulatory affairs, project management, translational science and comparative effectiveness (Koren et al, 2011;Jones et al, 2012;Sonstein et al, 2014;The Global Health Network, 2016;Calvin-Naylor et al, 2017;ACRP, 2019).…”

Section: Intended Use Of the Core Competencies In Pharmaceutical Medimentioning

confidence: 99%

Evolution of the Development of Core Competencies in Pharmaceutical Medicine and Their Potential Use in Education and Training

et al. 2020

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The evolution of postgraduate vocational education and training in pharmaceutical medicine is described alongside the growth of this scientific-medical discipline and profession for the development of new medicines. Over the past 50 years, whilst the training of competent professionals for their work has been paramount, this has paralleled the need to engage with the rapid and complex changes in R&D technologies, patient and healthcare system needs, and the ethical and regulatory obligations applied to the development of medicines throughout their lifecycle. The move from unstructured training to formal programs with syllabus, curricula and assessments for certification, has been accompanied by educational changes to outcomes-based, learner-centered, competency-based programs. The evolution of education and training along with the development of the set of 57 core competencies for professional practitioners in pharmaceutical medicine are described within the competence framework of seven domains: discovery of medicines and early development; clinical development and clinical trials; medicines regulation; drug safety and surveillance; ethics and subject protection; healthcare marketplace; communication and management. The application of the core competencies in a harmonized, international platform of education and training in medicines development at the undergraduate, postgraduate and continuing professional development levels would invigorate the potential for having a competent workforce with the intent to provide faster access to better and appropriate medicines for patients worldwide.

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Section: Intended Use Of the Core Competencies In Pharmaceutical Medimentioning

confidence: 99%

Evolution of the Development of Core Competencies in Pharmaceutical Medicine and Their Potential Use in Education and Training

et al. 2020

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“…Perceptions of competence were measured by asking CRCs to indicate their perceived level of competence on each of the eight core domains developed by the JTF for Clinical Trial Competency [24,25,32]. The list of eight domains represents researchers' efforts to acknowledge and incorporate a number of previous efforts to identify a comprehensive set of broad categories of knowledge, skills, and attitudes considered essential to function within the field of clinical research.…”

Section: Perceptions Of Competencementioning

confidence: 99%

Career orientation and perceived professional competence among clinical research coordinators

Rojewski

Choi

Hill

et al. 2019

J. Clin. Trans. Sci.

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Introduction:This study identified underlying career orientation types of clinical research coordinators (CRCs) using cluster analysis. Select career (satisfaction, engagement, and planning) and competency-related (perceived competence) information was used to identify four distinct career orientation types.Method:A web-based survey was administered to CRCs employed in one of four research institutions affiliated with a National Institutes of Health-funded Clinical and Translational Research Award (CTSA) in the southeastern USA. Each respondent completed a survey containing questions about personal background, individual attributes, perceived professional competence, and career orientation.Results:The first CRC type (35.2%) possessed a positive, knowledge-seeking orientation, characterized by high career-related scores but a conservative assessment of perceived competence. The second CRC type (18.6%) represented an optimistic and confident career orientation reflected in moderate to high scores on each of the four identifying factors. The third CRC type (27.6%) reflected an inconsistent career orientation highlighted by lowered perceived competence. The final CRC type (18.6%) reflected a disengaged orientation characterized by negative responses to all career and competence factors.Conclusion:Understanding the career orientation of CRCs can be helpful to institutional administrators and clinical investigators as they seek to support the professional development of CRCs through tailored training efforts or work-related supports. Knowledge of career orientation may also inform individual CRCs as they manage their personal career paths by assessing current levels of functioning, career-related strengths or weaknesses, and training needs.

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“…It may be necessary to partner with subject matter experts who understand CBE when navigating the competency mapping process. There are multiple evidence-based competency frameworks applicable to CTR education and training (NCATS, 2011;Calvin-Naylor et al, 2017;Sonstein et al, 2018). Table 2 shows training opportunities that have been mapped to one domain of an established CTR competency framework (Joint Task Force, 2018).…”

Section: Integrate Competency Framework Into Evaluation Planningmentioning

confidence: 99%

“…A key strategic goal of these CTSAs regards their development of the entire clinical and translational workforce through dedicated research training programs (NCATS, 2017). Clinical Translational Research (CTR) training programs are providing highly valued instruction on relevant research skills and so demands for rigorous evaluations that demonstrate their impact on the research workforce also continue to grow (Bonham et al, 2012;Calvin-Naylor et al, 2017).…”

Section: Introductionmentioning

confidence: 99%

Guidelines for Evaluating Clinical Research Training using Competency Assessments

Samuels¹,

Ianni²,

Chung³

et al. 2019

MedEdPublish

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Effective training programs in clinical and translational research (CTR) are critical to the development of the research workforce. The evolution of global CTR competencies frameworks motivates many CTR institutions to align their training offerings with these professional standards. Guidelines for integrating competency-based frameworks and assessments into rigorous program evaluations are needed in order to promote the quality and impact of these training programs. These guidelines provide practical suggestions for how to ensure that subjective and objective assessments of CTR knowledge and skill can be effectively integrated in the evaluations used to improve these essential training programs. The approach presented here necessarily involves the systematic and deliberate incorporation of these particular types of assessments into comprehensive evaluation plans. While these guidelines are broadly applicable to the work of those charged with developing, administering and evaluating CTR training programs, they have been specifically designed for use by program directors.

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Education and training of clinical and translational study investigators and research coordinators: A competency-based approach

Cited by 57 publications

References 10 publications

Evolution of the Development of Core Competencies in Pharmaceutical Medicine and Their Potential Use in Education and Training

Evolution of the Development of Core Competencies in Pharmaceutical Medicine and Their Potential Use in Education and Training

Career orientation and perceived professional competence among clinical research coordinators

Guidelines for Evaluating Clinical Research Training using Competency Assessments

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