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"clinical research workforce"
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Education and training of clinical research professionals and the evolution of the Joint Task Force for Clinical Trial Competency
by
Silva, Honorio
,
Sonstein, Stephen A.
,
Bierer, Barbara E.
in
academic programs in clinical research
,
Accreditation
,
clinical research professional
2024
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.
Journal Article
Reimagining the joint task force core competency framework for rural and frontier clinical research professionals conducting hybrid and decentralized trials
by
Johnson, Elizabeth A.
,
Kiesow, Becky
,
Besel, Jamie M.
in
clinical research professional
,
clinical trial enrollment
,
Clinical trials
2023
Introduction: Clinical research professionals (i.e., clinical research assistants, clinical research nurses, clinical research coordinators, etc.), as outlined by the Joint Task Force (JTF) Core Competency Framework, are highly trained to support the breadth of clinical trial operations and manage participant care. Clinical research professionals are uniquely equipped with a scope of practice that permits product administration, participant assessments, and data management. As clinical trials grow in complexity and their management expands beyond traditional, site-based operations models to decentralized and/or hybrid models, the need becomes great to ensure adequate staffing. However, rural hospitals frequently lack the research staff or patient recruiters that would allow them to support decentralized clinical trials across a sizeable rural geographic demographic. Methods: This paper examines the contributory factors of the clinical research professional workforce contraction and response efforts at professional and organizational levels within a large, Magnet-designated healthcare system in the rural northwestern United States. Perspectives are shared on adapting the Core Competency Framework to reflect the unique strengths and opportunities towards decentralized trials in rural regions of the United States and areas of priority for workforce cultivation and retention. A descriptive survey was used to gather initial data identifying the current research perspectives of healthcare workers working across a rural community. Participants were asked to complete questions about the JTF Competency domains and behavior-based questions. Analysis: Both competency and behavior-based questions were asked and related to roles. These were then cross-referenced using a Rasmussen Ladder system. Descriptive statistics were conducted for sample characteristics, self-reported competency domain questions, and behavior questions. Results and discussion: Survey findings suggest that although healthcare workers and clinical research teams interact, they are unlikely to ask their patients to participate in research. Based on the limited response rate, results suggest that better education throughout the rural community could benefit from decentralized research efforts. Increased use of technology was also highlighted as an area of interest.
Journal Article
Trends in turnover and turbulence at a large academic medical center before and during COVID-19: Analyzing structured clinical research professional roles
by
Gaudaur, Heather
,
Deeter, Christine
,
Snyder, Denise C.
in
clinical research professionals
,
Clinical research workforce
,
Costs
2025
High workforce turbulence has plagued clinical research, becoming intensified during the COVID-19 pandemic, especially for patient-facing workers. In a time of great uncertainty and risk among healthcare workers, researchers included, the pandemic also brought increased demand for research studies in volume, speed, and complexity, triggering elevated staff turnover. This has posed significant hurdles for employers, especially research sites, where retaining skilled patient-facing clinical research professionals (CRPs) is pivotal for sustaining medical innovation. Lack of job standardization and advancement pathways has been noted to play an important role both in turnover and contributes to the inability to accurately measure workforce trends. To address these factors, Duke University adopted a competency-based job classification system for CRPs in 2016.
Since that adoption of competency-based jobs, employee-level staffing data for all CRPs have been tracked monthly, creating a master data file from September 2016 through June 2024. This study updates previous analyses, evaluating turnover and turbulence rates, and demographic changes in the CRP workforce over this period.
Over the last six years, the Duke CRP workforce remained relatively stable. Voluntary turnover rates fluctuated, peaking at 19.1% in FY 2021 during the COVID-19 pandemic, and have steadily declined each year since then.
Despite national workforce challenges exacerbated by the pandemic, our data indicate that proactive measures to standardize clinical research jobs and assess the resultant well-defined site-based employee data may have mitigated extremes in workforce turnover at Duke University. Turbulence rates, while stabilizing, signal areas for further study.
Journal Article
Disseminating for impact: creating curriculum activities for translational dissemination for the clinical and translational research workforce
by
Keim-Malpass, Jessica
,
Johnston, Karen C.
,
Phillips, Jennifer
in
clinical research workforce
,
Collaboration
,
Curricula
2023
There has been an increased focus on the practices associated with dissemination for the translation of research to clinical practice and ultimately, policy. Simultaneously, there has been attention placed on the role of the clinical research workforce in supporting optimal dissemination efforts for impact and societal benefit. Curriculums focused on education opportunities for dissemination for translational scientists have been under-reported. The Translational Science Benefits Model (TSBM) is a framework that has been developed to support assessment of clinical and translational research outcomes that measure impact (both in the clinical and community setting) beyond traditional citations in academic journals/bibliometric activities. The TSBM framework outlines more than 30 different facets of impact and can provide a basis for operationalizing broad impacts of research for translational and clinical scientists. Engagement science offers methods and modalities to work with individual stakeholders, and collaborators in a team science model, and engagement with external scholars and society. This article will describe the use of the TSBM framework and engagement science strategies to develop a translational dissemination framework with novel components for evaluation of dissemination and implementation activities. We propose using the translational dissemination framework to guide the development of an educational curriculum for the clinical research workforce. We outline the educational domains and proposed evaluation criteria essential in implementing this innovative translational dissemination educational content for the clinical and translational research workforce.
Journal Article
KL2 mentored career development programs at clinical and translational science award hubs: Practices and outcomes
by
Scholl, Linda
,
Umans, Jason G.
,
Sorkness, Christine A.
in
clinical and translational research workforce
,
clinical and translational science awards
,
Education
2020
NIH Clinical and Translational Science Awards (CTSAs) include KL2 mentored career development awards for faculty commencing clinical and translational research. A survey of KL2 leaders revealed program practices, curricular elements and compelling data about scholar characteristics and outcomes.
We conducted a literature review, framed the survey construct, and obtained input from across the CTSA consortium. A REDCap survey was emailed in fall 2016 to 61 active programs.
Fifty-five programs (90.2%) responded. Respondents had been funded from 3 to 11 years, including 22 \"mature\" hubs funded for ≥8 years. Program cohort sizes were 56% \"small\", 22% \"medium\", and 22% \"large.\" Hubs offer extensive competency-aligned training opportunities relevant to clinical and translational research, including graduate degrees, mentorship, and grant-writing. Seventy-two percent of hubs report parallel \"KL2-equivalent\" career development programs. All hubs share their training and facilitate intermingling with other early stage investigators. A total of 1,517 KL2 scholars were funded. KL2 awardees are diverse in their disciplines, research projects, and representation; 54% are female and 12% self-identified as underrepresented in biomedical research. Eighty-seven percent of scholars have 2-3 mentors and are currently supported for 2-3 years. Seventy-eight percent of alumni remain at CTSA institutions in translational science. The most common form of NIH support following scholars' KL2 award is an individual career development award.
The KL2 is a unique career development award, shaped by competency-aligned training opportunities and interdisciplinary mentorship that inform translational research pathways. Tracking both traditional and novel outcomes of KL2 scholars is essential to capture their career trajectories and impact on health.
Journal Article
National Institutes of Health addresses the science of diversity
by
Francis S. Collins
,
Valantine, Hannah A
in
Biomedical Research
,
business enterprises
,
Career Choice
2015
The US biomedical research workforce does not currently mirror the nation’s population demographically, despite numerous attempts to increase diversity. This imbalance is limiting the promise of our biomedical enterprise for building knowledge and improving the nation’s health. Beyond ensuring fairness in scientific workforce representation, recruiting and retaining a diverse set of minds and approaches is vital to harnessing the complete intellectual capital of the nation. The complexity inherent in diversifying the research workforce underscores the need for a rigorous scientific approach, consistent with the ways we address the challenges of science discovery and translation to human health. Herein, we identify four cross-cutting diversity challenges ripe for scientific exploration and opportunity: research evidence for diversity’s impact on the quality and outputs of science; evidence-based approaches to recruitment and training; individual and institutional barriers to workforce diversity; and a national strategy for eliminating barriers to career transition, with scientifically based approaches for scaling and dissemination. Evidence-based data for each of these challenges should provide an integrated, stepwise approach to programs that enhance diversity rapidly within the biomedical research workforce.
Journal Article
Workforce Diversity Interactions and Perceptions Among Nurses in a Tertiary Maternity Facility in Qatar: A Sequential Explanatory Mixed‐Methods Study
by
Galvez, Barbara Lyn A.
,
Guino-o, Theresa
,
Salim Ibrahem, Rana Aatif
in
Adult
,
Citizenship
,
Clinical experience
2026
As the world becomes increasingly multicultural, the demand for a diverse nursing workforce rises to provide equitable and high-quality patient care. However, limited research has been conducted on these dynamics within the multicultural healthcare landscape of the Gulf region, especially in Qatar. Therefore, examining Qatar's multicultural workforce and the diversity interaction among nurses is essential to fill this research gap.
This study explored the experience of nurses and their level of interaction with a diverse workforce in a multicultural healthcare setting.
Sequential exploratory mixed-methods research was conducted at a tertiary maternity facility in Doha, Qatar. In Phase I, a survey was performed with 735 nurses using the Workforce Diversity Questionnaire II, followed by focus group discussions with 10 nurses from April to June 2024.
The findings revealed that nurses rated highly across all domains of workforce diversity interaction. The level of interaction is influenced by age, nationality, clinical experience, diversity of patient interactions, and the length of residency in a diverse community. While there were key barriers, some factors facilitated workforce diversity interaction.
This study recommends the development of training programs that focus on essential competencies for nurses to enhance their performance in diverse work settings. Further investigations are also recommended to assess the impact of these competencies and training programs to patient outcomes and organizational performance.
Journal Article
Engagement in research capability-building: Impact on healthcare workforce attraction and retention in rural and remote Australia – A scoping review protocol
2026
Geographic maldistribution of the health workforce remains a major challenge in Australia, with rural and remote communities experiencing persistent shortages that undermine access to and quality of care. Engagement in research is recognised as a potential mechanism for professional growth, continued learning, and improved workplace environments. Providing opportunities for health workers to participate in research or research capability-building (RCB) may therefore support workforce outcomes such as attraction and retention. This scoping review will identify and map existing evidence on the relationship between research engagement and health workforce outcomes in rural and remote Australia, and to summarise the factors that contribute to successful implementation of such initiatives.
We will conduct a scoping review of published and grey literature from Australia (2000 to present). Searches will be undertaken in CINAHL (EBSCO), Embase (Ovid), Global Health (Ovid), MEDLINE (Ovid), and PubMed, following the PRISMA-ScR 2020 guidelines and the Joanna Briggs Institute methodology for scoping reviews. Additional searches will be conducted through Google, Google Scholar, organisational websites, and snowballing of reference lists from included studies. Search terms will address four core concepts: (i) health professionals; (ii) research and RCB; (iii) workforce outcomes; and (iv) rural and remote Australian settings. Both qualitative and quantitative evidence will be included. Data will be synthesised using descriptive and thematic analysis, combining deductive approaches informed by the socioecological model and inductive approaches. Subgroup analyses will be undertaken where appropriate to provide deeper insights into the findings.
This scoping review will not involve human participants or primary data collection and does not require ethical approval. The results of this review will be published in a peer-reviewed journal.
Journal Article
Nurse staffing and inpatient mortality in the English National Health Service: a retrospective longitudinal study
by
Sigsworth, Janice
,
Zaranko, Ben
,
Sanford, Natalie Jean
in
Adult
,
Clinical outcomes
,
duty hours/work hours
2023
ObjectiveTo examine the impact of nursing team size and composition on inpatient hospital mortality.DesignA retrospective longitudinal study using linked nursing staff rostering and patient data. Multilevel conditional logistic regression models with adjustment for patient characteristics, day and time-invariant ward differences estimated the association between inpatient mortality and staffing at the ward-day level. Two staffing measures were constructed: the fraction of target hours worked (fill-rate) and the absolute difference from target hours.SettingThree hospitals within a single National Health Service Trust in England.Participants19 287 ward-day observations with information on 4498 nurses and 66 923 hospital admissions in 53 inpatient hospital wards for acutely ill adult patients for calendar year 2017.Main outcome measureIn-hospital deaths.ResultsA statistically significant association between the fill-rate for registered nurses (RNs) and inpatient mortality (OR 0.9883, 95% CI 0.9773 to 0.9996, p=0.0416) was found only for RNs hospital employees. There was no association for healthcare support workers (HCSWs) or agency workers. On average, an extra 12-hour shift by an RN was associated with a reduction in the odds of a patient death of 9.6% (OR 0.9044, 95% CI 0.8219 to 0.9966, p=0.0416). An additional senior RN (in NHS pay band 7 or 8) had 2.2 times the impact of an additional band 5 RN (fill-rate for bands 7 and 8: OR 0.9760, 95% CI 0.9551 to 0.9973, p=0.0275; band 5: OR 0.9893, 95% CI 0.9771 to 1.0017, p=0.0907).ConclusionsRN staffing and seniority levels were associated with patient mortality. The lack of association for HCSWs and agency nurses indicates they are not effective substitutes for RNs who regularly work on the ward.
Journal Article