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Abstract Introduction: The proportion of physician-investigators involved in biomedical research is shrinking even as the need for high-quality, interdisciplinary research is growing. Building the physician-investigator workforce is thus a pressing concern. Flexible, “light-weight” training modalities can help busy physician-investigators prepare for key stages of the research life cycle and personalize their learning to their own needs. Such training can also support researchers from diverse backgrounds and lighten the work of mentors. Materials and Methods: The University of Pittsburgh’s Institute for Clinical Research Education designed the Stackables Microcredentials in Clinical and Translational Research (Stackables) program to provide flexible, online training to supplement and enhance formal training programs. This training utilizes a self-paced, just-in-time format along with an interactive, storytelling approach to sustain learner engagement. Learners earn badges for completing modules and certificates for completing “stacks” in key competency areas. In this paper, we describe the genesis and development of the Stackables program and report the results of a pilot study in which we evaluated changes in confidence in key skill areas from pretest to posttest, as well as engagement and perceived effectiveness. Results: Our Stackables pilot study showed statistically significant gains in learner confidence in all skill areas from pretest to posttest. Pilot participants reported that the module generated high levels of engagement and enhanced their skills, knowledge, and interest in the subject. Conclusions: Stackables provide an important complement to formal coursework by focusing on discrete skill areas and allowing learners to access the training they need when they need it.

The University of California (UC) Davis Clinical and Translational Science Center has established the “Join the Team” model, a Clinical Research Coordinator workforce pipeline utilizing a community-based approach. The model has been extensively tested at UC Davis and demonstrated to generate a viable pathway for qualified candidates for employment in clinical research. The model combines the following elements: community outreach; professional training materials created by the Association for Clinical Research Professionals and adapted to the local environment; financial support to trainees to encourage ethnic and socioeconomic diversity; and internship/shadowing opportunities. The program is tailored for academic medical centers (AMCs) in recognition of administrative barriers specific to AMCs. UC Davis’s model can be replicated at other locations using information in this article, such as key program features and barriers faced and surmounted. We also discuss innovative theories for future program iterations.

Abstract Introduction: There are two main schools of thought about statistical inference: frequentist and Bayesian. The frequentist approach relies solely on available data for predictions, while the Bayesian approach incorporates both data and prior knowledge about the event of interest. Bayesian methods were developed hundreds of years ago; however, they were rarely used due to computational challenges and conflicts between the two schools of thought. Recent advances in computational capabilities and a shift toward leveraging prior knowledge for inferences have led to increased use of Bayesian methods. Methods: Many biostatisticians with expertise in frequentist approaches lack the skills to apply Bayesian techniques. To address this gap, four faculty experts in Bayesian modeling at the University of Michigan developed a practical, customized workshop series. The training, tailored to accommodate the schedules of full-time staff, focused on immersive, project-based learning rather than traditional lecture-based methods. Surveys were conducted to assess the impact of the program. Results: All 20 participants completed the program and when surveyed reported an increased understanding of Bayesian theory and greater confidence in using these techniques. Capstone projects demonstrated participants’ ability to apply Bayesian methodology. The workshop not only enhanced the participants’ skills but also positioned them to readily apply Bayesian techniques in their work. Conclusions: Accommodating the schedules of full-time biostatistical staff enabled full participation. The immersive project-based learning approach resulted in building skills and increasing confidence among staff statisticians who were unfamiliar with Bayesian methods and their practical applications.

Abstract Introduction: Clinical research requires a competent workforce of clinical research professionals (CRPs) who are well-trained to perform varied and complex tasks within their roles. The Joint Task Force for Clinical Trial Competency (JTF) framework established essential domains for conducting high-quality clinical research that can guide professional development of CRPs. The Research Professionals Network (RPN) Workshops were established in 2017 to focus on developing ongoing inter-institutional, peer-led, JTF-centric continuing education for CRPs. Four institutions and their affiliates are part of the collaboration. Methods: Workshop participant survey data and other metrics were collected over four academic years. Both quantitative and qualitative analyses were performed to assess participant experience and identify relevant themes. Results: Participants demonstrated overall high satisfaction with the workshops and significantly value the interpersonal, inter-institutional collaboration made possible through the workshops. Conclusions: These inter-institutional RPN Workshops have evolved into a Community of Practice, which can be expanded into future opportunities.

The Advancing the Science of Mentorship: Future Directions for Sustainable Implementation and Evaluation of Mentorship Education for the Clinical and Translational Science Workforce conference was held in Madison, Wisconsin, in April 2023. The conference provided an engaging and scholarly forum for clinical and translational researchers from diverse backgrounds and career stages (including leaders at Clinical and Translational Science Award (CTSA) hubs and affiliated institutions) with a professional interest and commitment to improving and diversifying workforce development and fostering a climate of inclusive excellence through best practices in mentorship. Outcomes from the conference include an online resource and a new Community of Practice.

Digital badges can provide condensed competency-based knowledge enabling individuals a chance to explore specialized careers in clinical research. A digital badge can be an efficient pathway to introduce clinical research job roles and educate a larger diverse workforce for clinical research coordinator positions at AMCs. The New Jersey Alliance for Clinical and Translational Science (NJ ACTS) developed a digital badge with potential to broaden exposure to training opportunities for CRCs and improve their prospects for a career at Rutgers. This paper describes the development of a digital badge introducing individuals to the clinical research profession, especially for those who aspire to become a CRC. The badge was designed to include five domains (Scientific Concepts and Research Design, Ethical and Participant Safety Considerations, Clinical Study Operations and Site Management, and Data Management and Informatics). Participants assessed the badge for accuracy and presentation level. The results demonstrated that the competencies were met, and content was appropriate for someone with limited knowledge of clinical research. Survey results along with the Difficulty Index and Discrimination Index calculated for quiz questions supported the badge rank as foundational. Research is ongoing to evaluate the value of the badge to job acquisition, performance, and career growth.

Translation of critical and broadly impactful health advancements is stymied by insufficient scientific scrutiny of barriers and roadblocks in the process. The Clinical & Translational Science Award (CTSA) funding opportunity announcement released in July 2021 makes clear the distinction between translational research and translational science (TS) and urges a shift from the former to the latter. This represents a significant shift in the overall scientific direction of the CTSA program and necessitates corresponding shifts in CTSA hub operations. To better support TS, the Team Science Core of the Duke CTSA hub designed and facilitated a virtual retreat for hub personnel that (1) enabled organizational learning about TS and (2) identified anticipated challenges and opportunities. A post-retreat survey was utilized to assess the degree to which the retreat met its stated goals. Our survey received a 62% response rate; 100% of respondents would recommend the session to others. Respondents also reported gains in all areas assessed, with evidence for greater understanding of TS and increased perspective of the value and relevance of TS. In this paper, we provide a roadmap for designing and implementing facilitated TS retreats, which we argue is a key step in TS capacity building through workforce development.

Clinical research professionals (CRPs) are essential contributors to clinical and translational research endeavors, encompassing roles such as research nurses, research coordinators, data managers, and regulatory affairs specialists. This paper reports on the implementation of a novel training program for the CRPs, the Co-mentoring Circles Program, developed by the University of Florida Health Clinical Research Professionals Consortium, and proposes an initial logic model of CRP workforce development informed by the observations, participant feedback, and the established Translational Workforce Logic Model. The co-mentoring program was delivered through an online didactic curriculum and bi-monthly meetings over nine months, from January to September 2022. The formative evaluation identified the factors that support CRP workforce development through knowledge acquisition and professional relationship building. Finally, this paper proposes a logic model of CRP workforce development, including financial and human inputs, didactic and co-mentoring activities, workforce outputs, outputs related to workforce and clinical research study progress, and resulting impacts of increased national capacity for translational research and increased rate of research translation.

Formal mentoring programs are increasingly recognized as critical for faculty career development. We describe a mentoring academy (MA) developed for faculty across tracks (i.e., researchers, clinicians, educators) within a "school of health" encompassing schools of medicine and nursing. The program is anchored dually in a clinical and translational science center and a school of health. The structure includes the involvement of departmental and center mentoring directors to achieve widespread uptake and oversight. A fundamental resource provided by the MA includes providing workshops to enhance mentoring skills. Initiatives for junior faculty emphasize establishing and maintaining strong mentoring relationships and implementing individual development plans (IDPs) for career planning. We present self-report data on competency improvement from mentor workshops and data on resources and barriers identified by junior faculty (n = 222) in their IDPs. Mentors reported statistically significantly improved mentoring competency after workshop participation. Junior faculty most frequently identified mentors (61%) and collaborators (23%) as resources for goal attainment. Top barriers included insufficient time and time-management issues (57%), funding limitations (18%), work-life balance issues (18%), including inadequate time for self-care and career development activities. Our MA can serve as a model and roadmap for providing resources to faculty across traditional tracks within medical schools.

In 2016, Duke reconfigured its clinical research job descriptions and workforce to be competency-based, modeled around the Joint Taskforce for Clinical Trial Competency framework. To ensure consistency in job classification amongst new hires in the clinical research workforce, Duke subsequently implemented a Title Picker tool. The tool compares the research unit’s description of job responsibility needs against those standardized job descriptions used to map incumbents in 2016. Duke worked with human resources and evaluated the impact on their process as well as on the broader community of staff who hire clinical research professionals. Implementation of the tool has enabled Duke to create consistent job classifications for its workforce and better understand who composes the clinical research professional workforce. This tool has provided valuable workforce metrics, such as attrition, hiring, etc., and strengthened our collaboration with Human Resources.

Inadequate training in the interpersonal skills of conducting informed consent conversations has long been noted as a challenge for clinical research recruitment and retention. To address this critical gap, Tufts Clinical and Translational Science Institute developed regular trainings for clinical research coordinators and other research staff on the practical skills of communicating informed consent using community members as simulated patients for role-playing exercises. In this paper, we assess the reach and effectiveness of these trainings and describe the impact of employing community stakeholders as simulated patients. We found that by embedding community members in the trainings, clinical research coordinators get to hear diverse perspectives, experience a range of patient responses, and learn from the lived experience of the communities that research tries to serve. Utilizing community members as trainers also helps to dismantle traditional power dynamics by demonstrating the organization’s commitment to inclusiveness and community engagement. Based on these findings, we suggest that training on informed consent include more simulated consent exercises that feature interaction with community members who can provide real-time feedback to coordinators.

Clinicians who are interested in becoming principal investigators struggle to find and complete training that adequately prepares them to conduct safe, well-designed clinical and translational research. Degree programs covering these skills require a significant time investment, while online trainings lack engagement and may not be specific to local research contexts. Staff at Tufts Clinical and Translational Science Institute sought to fill the gap in junior investigator training by designing an eight-module, noncredit certificate program to teach aspiring clinician-investigators about good clinical practice, clinical research processes, and federal and local regulatory requirements. The first iteration of this program was evaluated using pre- and posttest questionnaires and by gathering clinician learner feedback in a focus group. Based on the pre- and posttest questionnaires, learners experienced an increase in self-efficacy and confidence related to clinical research competencies. Feedback from learners also highlighted important program strengths, including an engaging program format, a manageable time commitment, and an emphasis on identifying crucial research resources. This article describes one approach to creating a meaningful and efficient clinical trial training program for clinicians.

Introduction: The proportion of physician-investigators involved in biomedical research is shrinking even as the need for high-quality, interdisciplinary research is growing. Building the physician-investigator workforce is thus a pressing concern. Flexible, "light-weight" training modalities can help busy physician-investigators prepare for key stages of the research life cycle and personalize their learning to their own needs. Such training can also support researchers from diverse backgrounds and lighten the work of mentors., Materials and Methods: The University of Pittsburgh's Institute for Clinical Research Education designed the Stackables Microcredentials in Clinical and Translational Research (Stackables) program to provide flexible, online training to supplement and enhance formal training programs. This training utilizes a self-paced, just-in-time format along with an interactive, storytelling approach to sustain learner engagement. Learners earn badges for completing modules and certificates for completing "stacks" in key competency areas. In this paper, we describe the genesis and development of the Stackables program and report the results of a pilot study in which we evaluated changes in confidence in key skill areas from pretest to posttest, as well as engagement and perceived effectiveness., Results: Our Stackables pilot study showed statistically significant gains in learner confidence in all skill areas from pretest to posttest. Pilot participants reported that the module generated high levels of engagement and enhanced their skills, knowledge, and interest in the subject., Conclusions: Stackables provide an important complement to formal coursework by focusing on discrete skill areas and allowing learners to access the training they need when they need it., Competing Interests: None., (© The Author(s) 2024.)

The University of California (UC) Davis Clinical and Translational Science Center has established the "Join the Team" model, a Clinical Research Coordinator workforce pipeline utilizing a community-based approach. The model has been extensively tested at UC Davis and demonstrated to generate a viable pathway for qualified candidates for employment in clinical research. The model combines the following elements: community outreach; professional training materials created by the Association for Clinical Research Professionals and adapted to the local environment; financial support to trainees to encourage ethnic and socioeconomic diversity; and internship/shadowing opportunities. The program is tailored for academic medical centers (AMCs) in recognition of administrative barriers specific to AMCs. UC Davis's model can be replicated at other locations using information in this article, such as key program features and barriers faced and surmounted. We also discuss innovative theories for future program iterations., Competing Interests: None., (© The Author(s) 2024.)

Abstract Introduction: Dissemination and implementation (D&I) science is not a formal element of the Clinical Translational Science Award (CTSA) Program, and D&I science activities across the CTSA Consortium are largely unknown. Methods: The CTSA Dissemination, Implementation, and Knowledge Translation Working Group surveyed CTSA leaders to explore D&I science-related activities, barriers, and needed supports, then conducted univariate and qualitative analyses of the data. Results: Out of 67 CTSA leaders, 55.2% responded. CTSAs reported directly funding D&I programs (54.1%), training (51.4%), and projects (59.5%). Indirect support (e.g., promoted by CTSA without direct funding) for D&I activities was higher – programs (70.3%), training (64.9%), and projects (54.1%). Top barriers included funding (39.4%), limited D&I science faculty (30.3%), and lack of D&I science understanding (27.3%). Respondents (63.4%) noted the importance of D&I training and recommended coordination of D&I activities across CTSAs hubs (33.3%). Conclusion:These findings should guide CTSA leadership in efforts to raise awareness and advance the role of D&I science in improving population health.

Abstract 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.

The University of Pittsburgh (Pitt) Clinical and Translational Science Institute (CTSI) and the nonprofit Bidwell Training Center co-developed a new program for translational workforce diversification and development to foster diversity and inclusion in clinical research. The STricklAnd Research Training (START) program provides students in the Medical Assistant program at Bidwell a career path in clinical research. We created a 12-hour didactic package that covers responsible conduct of human subjects research and good clinical practice as an add-on to existing vocational curriculums. Students have the option of completing a clinical research-related externship at Pitt, which includes mentoring, shadowing, and protocol-specific training on a study team whose intention is to hire them as a clinical research assistant. Those who accept a position at Pitt receive continued mentorship, education, and professional development through Pitt CTSI. In the first three cohorts, two of which had access to research externships at Pitt, 92% of students successfully completed the instruction in clinical research. We plan to expand START to new venues to train and hire local community members from diverse backgrounds who can bring their lived experience to research programs.

Abstract Background: Adequate equitable recruitment of underrepresented groups in clinical research and trials is a national problem and remains a daunting challenge to translating research discoveries into effective healthcare practices. Engagement, recruitment, and retention (ER&R) training programs for Clinical Research Professionals (CRPs) often focus on policies and regulations. Although some training on the importance of diversity and inclusion in clinical research participation has recently been developed, there remains a need for training that couples critical equity, diversity, and inclusion (EDI) concepts with skill development in effective recruitment and retention strategies, regulations, and best practices. Approach and methods: We developed the ER&R Certificate program as a holistic approach to provide Duke University CRPs the opportunity to build competency in gap areas and to increase comfort in championing equitable partnerships with clinical research participants. The thirteen core and elective courses include blended learning elements, such as e-learning and wiki journaling prompts, to facilitate meaningful discussions. Pre- and post-assessments administered to CRP program participants and their managers assessed program impact on CRP skills in ER&R tasks and comfort in equitable, diverse, and inclusive engagement of clinical research participants. Results and discussion: Results from the first two cohorts indicate that CRPs perceived growth in their own comfort with program learning objectives, especially those centered on participant partnership and EDI principles, and most managers witnessed growth in competence and responsibility for ER&R-related tasks. Results suggest value in offering CRPs robust training programs that integrate EDI and ER&R training.

Academic discovery in biomedicine is a growing enterprise with tens of billions of dollars in research funding available to universities and hospitals. Protecting and optimizing the resultant intellectual property is required in order for the discoveries to have an impact on society. To achieve that, institutions must create a multidisciplinary, collaborative system of review and support, and utilize connections to industry partners. In this study, we outline the efforts of Case Western Reserve University, coordinated through its Clinical and Translational Science Collaborative (CTSC), to promote entrepreneurial culture, and achieve goals of product development and startup formation for biomedical and population health discoveries arising from the academic ecosystem in Cleveland. The CTSC Office of Translation and Innovation, with the university’s Technology Transfer Office (TTO), helps identify and derisk promising IP while building interdisciplinary project teams to optimize the assets through key preclinical derisking steps. The benefits of coordinating funding across multiple programs, assuring dedicated project management to oversee optimizing the IP, and ensuring training to help improve proposals and encourage an entrepreneurial culture, are discussed in the context of a case study of therapeutic assets, the Council to Advance Human Health. This case study highlights best practices in academic innovation.

Abstract Background: Identification of evidence-based factors related to status of the clinical research professional (CRP) workforce at academic medical centers (AMCs) will provide context for National Center for Advancing Translational Science (NCATS) policy considerations and guidance. The objective of this study is to explore barriers and opportunities related to the recruitment and retention of the CRP workforce. Materials and Methods: Qualitative data from a series of Un-Meeting breakout sessions and open-text survey questions were analyzed to explore barriers and recommendations for improving AMC CRP recruitment, retention and diversity. Results: While certain institutions have established competency-based frameworks for job descriptions, standardization remains generally lacking across CTSAs. AMCs report substantial increases in unfilled CRP positions leading to operational instability. Data confirmed an urgent need for closing gaps in CRP workforce at AMCs, especially for attracting, training, retaining, and diversifying qualified personnel. Improved collaboration with human resource departments, engagement with principal investigators, and overcoming both organizational and resource challenges were suggested strategies, as well as development of outreach to universities, community colleges, and high schools raising awareness of CRP career pathways. Discussion: Based on input from 130 CRP leaders at 35 CTSAs, four National Institute of General Medical Sciences’ Institutional Development Award (IDeA) program sites, along with industry and government representatives, we identified several barriers to successful recruitment and retention of a highly trained and diverse CRP workforce. Results, including securing institutional support, champions, standardizing and adopting proven national models, improving local institutional policies to facilitate CRP hiring and job progression point to potential solutions.

Formal mentoring programs are increasingly recognized as critical for faculty career development. We describe a mentoring academy (MA) developed for faculty across tracks (i.e., researchers, clinicians, educators) within a “school of health” encompassing schools of medicine and nursing. The program is anchored dually in a clinical and translational science center and a school of health. The structure includes the involvement of departmental and center mentoring directors to achieve widespread uptake and oversight. A fundamental resource provided by the MA includes providing workshops to enhance mentoring skills. Initiatives for junior faculty emphasize establishing and maintaining strong mentoring relationships and implementing individual development plans (IDPs) for career planning. We present self-report data on competency improvement from mentor workshops and data on resources and barriers identified by junior faculty (n = 222) in their IDPs. Mentors reported statistically significantly improved mentoring competency after workshop participation. Junior faculty most frequently identified mentors (61%) and collaborators (23%) as resources for goal attainment. Top barriers included insufficient time and time-management issues (57%), funding limitations (18%), work–life balance issues (18%), including inadequate time for self-care and career development activities. Our MA can serve as a model and roadmap for providing resources to faculty across traditional tracks within medical schools.

Abstract Background: The University of Wisconsin Institute for Clinical and Translational Research hub supports multiple pilot award programs that engage cross-disciplinary Translational Teams. To support those teams, our Team Science group aims to offer a learning experience that is accessible, active, and actionable. We identified Collaboration Planning as a high-impact intervention to stimulate team-building activities that provide Translational Team members with the skills to lead and participate in high-impact teams. Methods: We adapted the published materials on Collaboration Planning to develop a 90-minute facilitated intervention with questions in 10 areas, presuming no previous knowledge of Science of Team Science (SciTS) or team-science best practices. Attendees received a short follow-up survey and submitted a written collaboration plan with their first quarterly progress report. Results: Thirty-nine participants from 13 pilot teams from a wide range of disciplines engaged in these sessions. We found that teams struggled to know who to invite, that some of our questions were confusing and too grounded in the language of SciTS, and groups lacked plans for managing their information and communications. We identified several areas for improvement including ensuring that the process is flexible to meet the needs of different teams, continuing to evolve the questions so they resonate with teams, and the need to provide resources for areas where teams needed additional guidance, including information and data management, authorship policies, and conflict management. Conclusions: With further development and testing, Collaboration Planning has the potential to support Translational Teams in developing strong team dynamics and team functioning.

Abstract Introduction: Community Advisory Boards (CABs) are typically comprised of adult community members who provide feedback on health-related, adult-focused research. Few, if any, CABs comprised of youth participants exist. In 2019, a Midwest medical center recruited a diverse group of 18 11–17-year-old community members to a Pediatric Advisory Board (PAB) to provide feedback on the recruitment and involvement of minors in research. Methods: Semi-structured interviews with n = 12 PAB members were conducted to understand their experiences and views on participating in the PAB. Parents (n = 7) were interviewed separately to assess the congruence of views on PAB membership between parents and their children. Interview transcripts were qualitatively analyzed to identify iterative themes. Results: PAB members thought the PAB addressed an unmet need of soliciting feedback from youth to develop age-appropriate study materials and to understand potential concerns of young participants. While PAB members expressed interest in the research topics presented by researchers, a few members indicated barriers to full participation, including lack of self-confidence, anxiety, and discomfort sharing opinions in a group setting. Parents supported their child’s PAB participation and hoped it would help them build confidence in developing and sharing their opinions in ways that were meaningful for them, which PAB members largely reported occurring over their period of involvement. Conclusion: Findings from a novel Midwest PAB indicated benefits to PAB members. While contributing to pediatric research planning by providing feedback on recruiting youth and improving study protocols, they gained confidence in providing opinions on biomedical research and developed their scientific literacy.

Clinical research coordinators are increasingly tasked with a multitude of complex study activities critical to scientific rigor and participant safety, though more than half report not receiving appropriate training. To determine the reproducibility of an established clinical research workforce orientation program, collaborative partners across Clinical and Translational Science Award institutions seeded core principles and structure from Mayo Clinic’s Clinical Research Orientation program within Penn State University and the University of Mississippi Medical Center from 2019 to 2021. Training concepts were established and tied to those domains deemed critical by the Joint Task Force for Clinical Trial Competency for the conduct of clinical research at the highest levels of safety and quality possible. Significant knowledge and confidence gains and high overall program satisfaction were reported across participants and partner sites, despite programs being required to pivot from traditional, in-person formats to entirely virtual platforms as a result of the COVID-19 pandemic. The successful standardization and translation of foundational clinical research training has important efficiency and efficacy implications for research enterprises across the USA.

Implementation science offers a compelling value proposition to translational science. As such, many translational science stakeholders are seeking to recruit, teach, and train an implementation science workforce. The type of workforce that will make implementation happen consists of both implementation researchers and practitioners, yet little guidance exists on how to train such a workforce. We—members of the Advancing Dissemination and Implementation Sciences in CTSAs Working Group—present the Teaching For Implementation Framework to address this gap. We describe the differences between implementation researchers and practitioners and demonstrate what and how to teach them individually and in co-learning opportunities. We briefly comment on educational infrastructures and resources that will be helpful in furthering this type of approach.

Underrepresentation of Black biomedical researchers demonstrates continued racial inequity and lack of diversity in the field. The Black Voices in Research curriculum was designed to provide effective instructional materials that showcase inclusive excellence, facilitate the dialog about diversity and inclusion in biomedical research, enhance critical thinking and reflection, integrate diverse visions and worldviews, and ignite action. Instructional materials consist of short videos and discussion prompts featuring Black biomedical research faculty and professionals. Pilot evaluation of instructional content showed that individual stories promoted information relevance, increased knowledge, and created behavioral intention to promote diversity and inclusive excellence in biomedical research.

Research collaboration is an essential research skill that promotes diversity and inclusion in research and requires comprehensive curriculum and instructional methods to provide early-stage trainees with low-risk, scaffolded experiences of collaborative research practice. Strategic Team Science is an instructional method that introduces biomedical science trainees to an inclusive way of thinking, capitalizes on the diversity of individual capabilities, and provides scaffolded experience of cross-disciplinary collaboration. Pilot results show that guided dialogues around Strategic Team Science increase research self-efficacy and interdisciplinary research orientation. Scaffolded collaboration dialogues allow students from diverse disciplines to engage actively and share ideas equitably.

Introduction: Clinical research requires a competent workforce of clinical research professionals (CRPs) who are well-trained to perform varied and complex tasks within their roles. The Joint Task Force for Clinical Trial Competency (JTF) framework established essential domains for conducting high-quality clinical research that can guide professional development of CRPs. The Research Professionals Network (RPN) Workshops were established in 2017 to focus on developing ongoing inter-institutional, peer-led, JTF-centric continuing education for CRPs. Four institutions and their affiliates are part of the collaboration., Methods: Workshop participant survey data and other metrics were collected over four academic years. Both quantitative and qualitative analyses were performed to assess participant experience and identify relevant themes., Results: Participants demonstrated overall high satisfaction with the workshops and significantly value the interpersonal, inter-institutional collaboration made possible through the workshops., Conclusions: These inter-institutional RPN Workshops have evolved into a Community of Practice, which can be expanded into future opportunities., Competing Interests: This work was presented in part during a session of the Association of Clinical and Translational Science Annual Meeting on April 19, 2022., (© The Author(s) 2024.)

The Advancing the Science of Mentorship: Future Directions for Sustainable Implementation and Evaluation of Mentorship Education for the Clinical and Translational Science Workforce conference was held in Madison, Wisconsin, in April 2023. The conference provided an engaging and scholarly forum for clinical and translational researchers from diverse backgrounds and career stages (including leaders at Clinical and Translational Science Award (CTSA) hubs and affiliated institutions) with a professional interest and commitment to improving and diversifying workforce development and fostering a climate of inclusive excellence through best practices in mentorship. Outcomes from the conference include an online resource and a new Community of Practice., Competing Interests: There are no conflicts of interest., (© The Author(s) 2024.)

IntroductionResearch coordinators (RCs) are vital to the clinical research enterprise, ensuring research is conducted ethically, results are scientifically sound and human research subjects are protected. Given the absence of a prior systematic inquiry, we sought to understand the ways in which Clinical & Translational Science Award-funded academic health centers support RCs.MethodsOur survey asked questions about existing coordinator networks and where none existed, collected data on the characterization of resources and services provided to support RCs (outside of salary).ResultsFindings show 4 mechanisms support RCs: identification of the workforce, professionalization of the position, dissemination of information, and offering of services.ConclusionAn academic health center that wishes to deliver research training and services to their RC workforce will need identification and communication structures in place before supportive activities can be effectively implemented.

Digital badges can provide condensed competency-based knowledge enabling individuals a chance to explore specialized careers in clinical research. A digital badge can be an efficient pathway to introduce clinical research job roles and educate a larger diverse workforce for clinical research coordinator positions at AMCs. The New Jersey Alliance for Clinical and Translational Science (NJ ACTS) developed a digital badge with potential to broaden exposure to training opportunities for CRCs and improve their prospects for a career at Rutgers. This paper describes the development of a digital badge introducing individuals to the clinical research profession, especially for those who aspire to become a CRC. The badge was designed to include five domains (Scientific Concepts and Research Design, Ethical and Participant Safety Considerations, Clinical Study Operations and Site Management, and Data Management and Informatics). Participants assessed the badge for accuracy and presentation level. The results demonstrated that the competencies were met, and content was appropriate for someone with limited knowledge of clinical research. Survey results along with the Difficulty Index and Discrimination Index calculated for quiz questions supported the badge rank as foundational. Research is ongoing to evaluate the value of the badge to job acquisition, performance, and career growth., Competing Interests: None., (© The Author(s) 2024.)

Translation of critical and broadly impactful health advancements is stymied by insufficient scientific scrutiny of barriers and roadblocks in the process. The Clinical & Translational Science Award (CTSA) funding opportunity announcement released in July 2021 makes clear the distinction between translational research and translational science (TS) and urges a shift from the former to the latter. This represents a significant shift in the overall scientific direction of the CTSA program and necessitates corresponding shifts in CTSA hub operations. To better support TS, the Team Science Core of the Duke CTSA hub designed and facilitated a virtual retreat for hub personnel that (1) enabled organizational learning about TS and (2) identified anticipated challenges and opportunities. A post-retreat survey was utilized to assess the degree to which the retreat met its stated goals. Our survey received a 62% response rate; 100% of respondents would recommend the session to others. Respondents also reported gains in all areas assessed, with evidence for greater understanding of TS and increased perspective of the value and relevance of TS. In this paper, we provide a roadmap for designing and implementing facilitated TS retreats, which we argue is a key step in TS capacity building through workforce development., Competing Interests: None., (© The Author(s) 2024.)

Clinical research professionals (CRPs) are essential contributors to clinical and translational research endeavors, encompassing roles such as research nurses, research coordinators, data managers, and regulatory affairs specialists. This paper reports on the implementation of a novel training program for the CRPs, the Co-mentoring Circles Program, developed by the University of Florida Health Clinical Research Professionals Consortium, and proposes an initial logic model of CRP workforce development informed by the observations, participant feedback, and the established Translational Workforce Logic Model. The co-mentoring program was delivered through an online didactic curriculum and bi-monthly meetings over nine months, from January to September 2022. The formative evaluation identified the factors that support CRP workforce development through knowledge acquisition and professional relationship building. Finally, this paper proposes a logic model of CRP workforce development, including financial and human inputs, didactic and co-mentoring activities, workforce outputs, outputs related to workforce and clinical research study progress, and resulting impacts of increased national capacity for translational research and increased rate of research translation., Competing Interests: Authors have no conflicts of interest to disclose., (© The Author(s) 2024.)

Introduction The National Clinical and Translational Science Award (CTSA) Consortium 2.0 has developed common metrics as a collaborative project for all participating sites. Metrics address several important aspects and functions of the consortium, including workforce development. The first workforce development metrics to be proposed for all CTSA hubs include the proportion of CTSA-supported trainees and scholars with sustainable careers in translational research and the diversity and inclusiveness of programs. Methods and results The University of Utah Center for Clinical and Translational Science (CCTS), a CTSA hub, has been actively engaged in mentoring translational scientists for the last decade. We have developed programs, processes, and institutional policies that support translational scientists, which have resulted in 100% of our KL2 scholars remaining engaged in translational science and in increasing the inclusion of individuals under-represented in medicine in our research enterprise. In this paper, we share details of our program and what we believe are evidence-based best practices for developing sustainable translational research careers for all aspiring junior faculty members. Conclusions The University of Utah Center for Clinical and Translational Science has been integral in catalyzing interactions across the campus to reverse the negative trends seen nationally in sustaining clinician scientists. Our programs and processes can serve as a model for other institutions seeking to develop translational scientists.

In 2016, Duke reconfigured its clinical research job descriptions and workforce to be competency-based, modeled around the Joint Taskforce for Clinical Trial Competency framework. To ensure consistency in job classification amongst new hires in the clinical research workforce, Duke subsequently implemented a Title Picker tool. The tool compares the research unit's description of job responsibility needs against those standardized job descriptions used to map incumbents in 2016. Duke worked with human resources and evaluated the impact on their process as well as on the broader community of staff who hire clinical research professionals. Implementation of the tool has enabled Duke to create consistent job classifications for its workforce and better understand who composes the clinical research professional workforce. This tool has provided valuable workforce metrics, such as attrition, hiring, etc., and strengthened our collaboration with Human Resources., Competing Interests: The authors have no conflicts of interest to declare., (© The Author(s) 2023.)

Inadequate training in the interpersonal skills of conducting informed consent conversations has long been noted as a challenge for clinical research recruitment and retention. To address this critical gap, Tufts Clinical and Translational Science Institute developed regular trainings for clinical research coordinators and other research staff on the practical skills of communicating informed consent using community members as simulated patients for role-playing exercises. In this paper, we assess the reach and effectiveness of these trainings and describe the impact of employing community stakeholders as simulated patients. We found that by embedding community members in the trainings, clinical research coordinators get to hear diverse perspectives, experience a range of patient responses, and learn from the lived experience of the communities that research tries to serve. Utilizing community members as trainers also helps to dismantle traditional power dynamics by demonstrating the organization's commitment to inclusiveness and community engagement. Based on these findings, we suggest that training on informed consent include more simulated consent exercises that feature interaction with community members who can provide real-time feedback to coordinators., Competing Interests: The authors have no conflicts of interest to declare., (© The Author(s) 2023.)

The University of Pittsburgh (Pitt) Clinical and Translational Science Institute (CTSI) and the nonprofit Bidwell Training Center co-developed a new program for translational workforce diversification and development to foster diversity and inclusion in clinical research. The STricklAnd Research Training (START) program provides students in the Medical Assistant program at Bidwell a career path in clinical research. We created a 12-hour didactic package that covers responsible conduct of human subjects research and good clinical practice as an add-on to existing vocational curriculums. Students have the option of completing a clinical research-related externship at Pitt, which includes mentoring, shadowing, and protocol-specific training on a study team whose intention is to hire them as a clinical research assistant. Those who accept a position at Pitt receive continued mentorship, education, and professional development through Pitt CTSI. In the first three cohorts, two of which had access to research externships at Pitt, 92% of students successfully completed the instruction in clinical research. We plan to expand START to new venues to train and hire local community members from diverse backgrounds who can bring their lived experience to research programs., (© The Author(s) 2022.)

Background: Adequate equitable recruitment of underrepresented groups in clinical research and trials is a national problem and remains a daunting challenge to translating research discoveries into effective healthcare practices. Engagement, recruitment, and retention (ER&R) training programs for Clinical Research Professionals (CRPs) often focus on policies and regulations. Although some training on the importance of diversity and inclusion in clinical research participation has recently been developed, there remains a need for training that couples critical equity, diversity, and inclusion (EDI) concepts with skill development in effective recruitment and retention strategies, regulations, and best practices., Approach and Methods: We developed the ER&R Certificate program as a holistic approach to provide Duke University CRPs the opportunity to build competency in gap areas and to increase comfort in championing equitable partnerships with clinical research participants. The thirteen core and elective courses include blended learning elements, such as e-learning and wiki journaling prompts, to facilitate meaningful discussions. Pre- and post-assessments administered to CRP program participants and their managers assessed program impact on CRP skills in ER&R tasks and comfort in equitable, diverse, and inclusive engagement of clinical research participants., Results and Discussion: Results from the first two cohorts indicate that CRPs perceived growth in their own comfort with program learning objectives, especially those centered on participant partnership and EDI principles, and most managers witnessed growth in competence and responsibility for ER&R-related tasks. Results suggest value in offering CRPs robust training programs that integrate EDI and ER&R training., (© The Author(s) 2022.)