Clinical Research Professionals Research Articles

A Novel Model of Inter-institutional, Peer-led, Competency-based, Interactive Workshops for Continuing Education and Professional Development of Clinical Research Professionals

A Novel Model of Inter-institutional, Peer-led, Competency-based, Interactive Workshops for Continuing Education and Professional Development of Clinical Research Professionals

132 Modernizing Onboarding for Clinical Research Professionals: An Interactive and Adoptable Approach

OBJECTIVES/GOALS: The Clinical Research Professionals (CRP) at Cincinnati Children’s Hospital Medical Center (CCHMC) identified and addressed gaps in a static on boarding material by transforming it into an interactive, centralized, and customizable REDCap checklist to better meet researcher needs across the institution. METHODS/STUDY POPULATION: The CRP On boarding Checklist is a tool designed to assist clinical researchers in their onboarding process at CCHMC. This tool helps CRPs determine the required/recommended trainings available to assist with skill-building and establishing job role competency. CRP supervisorsand subject matter experts were included incontent revisions, format, and transition to a RED Capsurvey. The new checklist is interactive, targets training requirements by job function, and clearly labels mandatory training. A companion document allows new CRPs to create and track their own individualized training plan. RESULTS/ANTICIPATED RESULTS: The revised CRP On boarding Checklist was launched in April 2022 and announced via email communication. Alive demonstration was presented to all CRPs during the May 2022 CRP Monthly Meeting. The checklist and companion document are linked to the internal CRP website, which is accessible institutionally. Sincelaunch, almost 100 new and internally transferring CRPs have utilized the online tool to guide their training needs. The checklist is intended to reflect real-time changes in educational offerings. In addition to feedback and change requests from the CRP community, the checklist is updated as necessary and routinely reviewed on a biannual basisby the CRP Education Committee. DISCUSSION/SIGNIFICANCE: The creation and maintenance of the CRP Onboarding Checklist is a modern and accessible way for CRPs and supervisors to explore role-applicable training and take active roles in the on boarding process. The RED Capformat allows easy sharing and adoptability to other institutions via data dictionary.

145 Enhancing team science education and training through discussions, examples and vignettes tailored to Clinical Research Professionals (CRPs)

OBJECTIVES/GOALS: To describe team science training that can be tailored to specific audiences, in this case, Clinical Research Professionals (CRP) using discipline-specific vignettes, and to highlight the benefits of audience-specific training in team science. METHODS/STUDY POPULATION: Translational science teams are comprised of members from various disciplines. All members can benefit from team science training. Our education team has incorporated discipline-specific training into educational offerings. This project focuses on education tailored to CRPs and their role in clinical research. Historically, team science training has been focused on faculty and trainees. The exclusion of CRPs can limit the impact of this training. We’ve created workshops specifically geared toward CRPs. This presentation demonstrates how we tailor team science training to CRPs by using relevant examples and real-world vignettes to highlight concepts. RESULTS/ANTICIPATED RESULTS: The team science workshops conducted specifically for CRPs have been well received. CRPs have been eager to engage with team science-related material. The number of team science workshops requested by CRP groups is continuing to increase. We will share both quantitative and qualitative evaluation results from several team science workshops conducted to-date. The inclusion of scenarios that relate to common situations encountered by CRPs has been especially helpful in demonstrating team science concepts they have personally experienced. DISCUSSION/SIGNIFICANCE: Helping CRPs directly apply team science concepts to their work is very valuable for improving high-functioning team behavior. CRPs can use new knowledge and skills to enhance efficiency and reduce stress and burnout. The impact of team science is maximized when all members of the team are trained.

113 Creation of an undergraduate certificate program in clinical and translational science following a six-step curriculum development process

OBJECTIVES/GOALS: Academic research centers often struggle to recruit and retain a diverse and competent clinical and translational science (CTS) workforce. Specifically, the clinical research professional (CRP) career pathway is not well known to undergraduate students and other individuals outside of academic medicine despite various potential career routes. METHODS/STUDY POPULATION: To address these workforce challenges, the CRP Task Force at the University of Cincinnati (UC) aims to train a competent and diverse CRP workforce through targeted educational programming in the UC undergraduate population. Using a six-step curriculum development process that included: 1) performing a needs assessment, 2) determining content, 3) writing goals and objectives, 4) selecting the educational strategies, 5) implementing the curriculum, and 6) evaluating the curriculum, we designed an undergraduate certificate program in CTS. RESULTS/ANTICIPATED RESULTS: The needs assessment included both internal and external data gathering to inform curriculum development and program decisions. Content was determined using the CRP Competency Framework 2.0, and program learning outcomes were written with both the competency framework and local workforce needs in mind. Educational strategies were selected based upon optimization of available resources and local expertise with an emphasis on interactive didactics complemented by experiential learning. Implementation is underway and evaluation will follow once students begin enrolling. DISCUSSION/SIGNIFICANCE: We anticipate an increase in numbers of well-qualified, diverse applicants who pursue CRP careers locally and regionally. In addition, we expect that the certificate program will build competency earlier in CRP staff, improving job satisfaction and retention as a result of a stronger foundation from which to build their professional skills.

114 Reimagining Entryways: Innovative Apprenticeship Models for New Clinical Research Professionals

OBJECTIVES/GOALS: 1. Standardize pathways, training and evaluations 2. Expose apprentices to a variety of research experiences 3. Remove barriers to hiring early talent 4. Expand opportunities for underrepresented minority applicants to obtain clinical research professional positions METHODS/STUDY POPULATION: Collaborators connected by the Clinical Research Professional Taskforce ACTS SIG conducted a landscape analysis survey to identify aspects of CRP Apprentice models and formed a Subgroup. Members will share plans for multiple apprenticeship programs, including specific training modalities and skill sets used to prepare apprentices for a successful clinical research professional career. Methods across institutions include: • Increasing awareness of the profession • Facilitating talent identification for managers • Making the business case for funding and staffing • Implementing work-based learning for fundamental competency development Survey results from CRP institutions demonstrated apprenticeships are value added to teaching how to conduct research. RESULTS/ANTICIPATED RESULTS: The landscape survey of Apprentice programs revealed multiple models in use. The newly formed Apprentice subgroup is engaging in analysis and actively working to build a standardized repository of competency-aligned, research courses and experiences for apprentices. Results will help make the business case for starting or growing programs. Subgroup members have focused on a shared goal of expanding opportunities for underrepresented minority applicants, with current outreach efforts that are extending awareness of the CRP profession. We anticipate a continuous strengthening of connections between institutions to share a variety of models to implement, develop shared tools (e.g., proficiency tests), and share existing tools to standardize pathways and training for CRP apprenticeships. #_msoanchor_1 DISCUSSION/SIGNIFICANCE: Academic Medical Centers (AMCs) need novel strategies to support clinical research portfolios.Innovative Apprenticeship Models improve efficiency and sustainability of the clinical research professional (CRP) workforce to train the next generation of CRPs in an effective and timely way.

125 Insights from a Process Improvement Co-op in the Development of an Informed Consent Professional Certificate (ICPC) Course

OBJECTIVES/GOALS: The objectives of the ICPC Course were 1) to define elements needed to 'build' a solid framework for the creation of an effective informed consent document; 2) to examine various regulatory references and their importance in the context of the informed consent process; and 3) to review helpful tips and best practices of the informed consent process. METHODS/STUDY POPULATION: This 7-week course was a multi-disciplinary effort by the Miami CTSI, the Regulatory and Monitoring Support Office and the Human Subjects Research Office (HSRO), as part of their co-op partnership. The CTSI’s Network of Clinical Research Professionals (NCRP) (over 1995 members and established to offer and enhance education, training, and overall career development and networking for the U’s diverse research workforce) served as the target audience. The lead HSRO official was the course content developer and served as instructor. The Director of the HSRO served as the certificate & program coordinator. Additionally, this course indirectly fulfilled part of the requirements of the Institution’s AAHRPP re-accreditation. RESULTS/ANTICIPATED RESULTS: 70 persons attended all sessions and received their certificate. A post-course survey was deployed (n=70). 69 respondents were extremely satisfied with course content; 67 were likely to recommend the course to a colleague. Feedback highlights include: appreciation for time taken to organize/offer the course; presenter knowledge and preparation; and that case studies/examples were up-to-date and applicable. As an added incentive to participate in the course, both the School of Nursing and the Medical School provided CEU credits and the Society of Clinical Research Associates (SOCRA) accepted documentation of candidate participation in continuing education programs for recertification. DISCUSSION/SIGNIFICANCE: Based on a need identified through a multi-disciplinary process, a successful Informed Consent Professional Certificate Course was created and implemented. Respondents indicate extremely high satisfaction with the course and felt it was very relevant and applicable to their practice.

117 Applying the Competency Index for Clinical Research Professionals (CICRP) for Educational Program Evaluation

OBJECTIVES/GOALS: To demonstrate the value of the Competency Index for Clinical Research Professional (CICRP) as a tool in program evaluation using a pre- and post- design to evaluate student perceived self-efficacy in clinical trial competencies at program entry and at program completion. METHODS/STUDY POPULATION: Using a separate-sample pre-post study design, we administered the CICRP questionnaire to students in the entry and exit courses of the Master of Clinical Research (MCR) Program during the 2021-2022 academic year, using QualtricsTM (Provo, Utah) survey instrument for use on desktop or mobile device. We included the 20 CICRP competency items asking students to rate their self-efficacy in performing each item using a Likert Scale (from 0-10) (0=not at all confident; 10= extremely confident). Links to the survey were included in the courses for the foundational entry course and for the final culminating project course. RESULTS/ANTICIPATED RESULTS: Overall, 54 students took the CICRP during the entry course and 56 during the exit. Cronbach’s alpha for each assessment ranged from 0.93 to 0.98. Both the Welch’s two-sample t-test and Wilcoxon rank-sum test show very significant differences between the group of students entering the program and leaving the program (p value < 0.001). A significant increase in mean CICRP total score is seen at each experience level between program entry and program exit (p<0.001) A linear regression, adjusting for available covariates, individuals taking the exit course have a mean CICRP total score 92.690 (p value < 0.001) higher than individuals taking the entry course. DISCUSSION/SIGNIFICANCE: Competency indices have been used to measure self-efficacy in translational research scientists, thus the use of CICRP to measure self-efficacy can be useful in assessing whether our competency-based program is meeting the JTF Competency needs of students.

139 Adapting Center for Improvement of Mentored Experiences in Research (CIMER) Mentor Training for Clinical Research Professionals: A Process Description

OBJECTIVES/GOALS: Learn how the National Organization of Research Development Professionals (NORDP) adapted the Center for Improvement of Mentored Experiences in Research (CIMER) NIH-funded evidenced-based mentor training curriculum for research development professionals and how the curriculum will be further adapted for clinical research professionals. METHODS/STUDY POPULATION: NORDP pioneered the adaptation of the CIMER curriculum for professional research staff. In addition to revamping the case studies and ensuring the curriculum was appropriately staff-centric, the NORDP team developed best practices for adapting the curriculum. This approach included four phases: (1) developing expertise in mentor training, (2) adapting curriculum for staff, (3) creating role-specific case studies, and (4) integrating mentor training with institutional or professional association-based mentoring programs. In collaboration with CIMER and units at the University of Minnesota (UMN), the mentor training model for research development will be further adapted for clinical research staff, i.e. coordinators, regulators, facilitators. RESULTS/ANTICIPATED RESULTS: This poster will discuss the preliminary work of adapting the curriculum for clinical research professionals by the UMN’s Departments of Family Medicine and Community Health and Clinical and Translational Science Institute’s Translational Workforce Development team. The anticipated short to mid-term outcomes of this work include: (1) improved research professionals mentoring knowledge and skills, (2) diversity addressed across research roles, (3) reduced staff turnover and associated costs, (4) increased staff job satisfaction and moral, and (5) research culture changed to value mentoring excellence across the academic enterprise. DISCUSSION/SIGNIFICANCE: Research mentoring has traditionally been focused on faculty and trainees. Given the unique skill sets and increasing complexity of research staff roles, mentoring can increase job satisfaction and reduce the overall costs related to turnover, i.e. research productivity, loss of institutional knowledge, hiring costs, etc.

520 Johns Hopkins Institute for Clinical and Translational Research (ICTR) - Research Personnel Onboarding Program

OBJECTIVES/GOALS: In Sep 2022, Johns Hopkins Research Coordinator Support Service launched Research Personnel Onboarding Program. The program on board in experienced individuals in 6-8 weeks, tailoring training plans to Investigator and study needs. It also offers Ongoing Support to enhance sustainability and adaptability. METHODS/STUDY POPULATION: * Assess Principal Investigator (PI)’s need Evaluate study’s need Understand trainee’s background Develop a personalized training plan (∼6-8 weeks) Weekly updates Ongoing mentorship Research staff spend 200+ training hours, depending on their need. Training encompasses various modalities: Interactive 1:1 onboarding sessions, Online, and Instructor-led trainings and sessions cover a wide range of topics, including: * Mandatory JHU/Institutional Review Board trainings * Good Clinical Practice * Regulatory submissions * Screening/Consenting * Monitoring/Auditing * Visit conduct * Clinical skills * Soft Skills Figure 1. Chart shows cumulative onboarding hours that focus on “How” to do tasks Figure 2. Chart shows cumulative training hours that focus on regulations, ethics and “Why” for tasks RESULTS/ANTICIPATED RESULTS: * The program contributed nearly 4000 hrs. of research staff training in the past 1 year * The program received 26 requests from investigators; 14 Completed the onboarding program, 1 Active, 5 Projected (Future start date), and 6 Cancelled (HR issues, lack of fund, or hired a trained staff) * 22 requests opted in the “Ongoing Support” * Ongoing Support, is averaged at 1 hr./month for the first 3-6 months. This indicates program success in empowering independent task performance * Developing REDCap request had significantly reduced meetings and paperwork * Web-Based Clockify invoicing has drastically reduced monthly manually invoicing processing time DISCUSSION/SIGNIFICANCE: * Grow the next generation of clinical research professionals * Centralize and standardize expert onboarding throughout the University * Improve outcomes, enhanced productivity, knowledge sharing, collaboration, and innovation * Decrease frustration and enhance satisfaction of trainees and departments

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

Accreditation 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. We 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). The 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. This 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.

Operational Differences between Product Development Partnership, Pharmaceutical Industry, and Investigator Initiated Clinical Trials.

Medicine development is a lengthy endeavour. Increasing regulatory stringency and trial complexity might lead to reduced efficiency, dwindled output, and elevated costs. However, alternative models are possible. We compared the operational differences between pharmaceutical industry sponsored trials, product development partnership trials, and investigator-initiated trials to identify key drivers of inefficiency in clinical research. We conducted an exploratory mixed-methods study with stakeholders, including clinical trial sponsors, contract research organisations, and investigators. The qualitative component included 40 semi-structured interviews, document reviews of 12 studies and observations through work shadowing in research institutions in Burkina Faso, Mali, and Switzerland. The findings were triangulated with an online survey polling clinical research professionals. The operational differences were grouped under five categories: (i) trial start-up differences including governance and management structure; (ii) study complexity; (iii) site structural and organisational differences; (iv) study conduct, quality approaches, and standard operating procedures; and (v) site capacity strengthening and collaboration. Early involvement of sites in the planning and tailored quality approaches were considered critical for clinical operations performance. Differences between the types of trials reviewed pertained to planning, operational complexities, quality approaches, and support to the sites. Integration of quality-by-design components has the potential to alleviate unnecessary process burden.

Enhancing the clinical research workforce: a collaborative approach with human resources.

Jobs for clinical research professionals (CRPs) have grown increasingly complex over the past 20+ years. This is due largely to additional administrative burden for investigators, study teams, sponsors, Clinical Research Organizations (CROs), and sites, particularly Academic Medical Centers (AMCs). Furthermore, National Institutes of Health (NIH) has reduced capacity to effectively fund research recognizing this is dependent on the overall congressional budget, which creates greater pressure for clinician scientists to secure external support. It is widely known clinical research will continue to become increasingly more complex for clinician scientists. This manuscript explores adoption of a clinical research competency-based job classification framework from the Joint Task Force for Clinical Trial Competency (JTFCTC) across several AMCs and the role of Human Resources (HR) in facilitating this process. This collaboration focuses on fostering successful projects tied to the business case in order to address equity and improve support for the clinical research enterprise.

The Role of Predictive Models in Managing Operation Risk and Workload in Clinical Trial

Changes in the regulatoryenvironment and external factors, such as the recent COVID-19 pandemic, haveforced pharmaceutical companies and Clinical Research Organizations tore-evaluate how they engage with and support investigator sites. This paperdescribes using AI (Artificial Intelligence) based algorithms to model investigatorsite performance and create predictive analytics for workload and risks coupledwith key risk and performance indicators for clinical research professionals atSponsor. It describes how clinical operations can move to an operating modelbased upon dynamic approaches for monitoring studies and participating sites.&amp;nbsp;

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

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.

Supporting clinical research professionals through educational innovations.

Clinical Research Professionals (CRPs) are essential members of the Clinical and Translational Research Workforce. Many academic medical institutions struggle to recruit and retain these vital team members. One strategy to increase job satisfaction and promote the retention of CRPs is through educational initiatives that provide training and professional development. The South Carolina Clinical and Translational Research (SCTR) Institute Workforce Development (WD) team at the Medical University of South Carolina (MUSC) developed several trainings as part of our larger educational portfolio for CRPs. In 2022 WD implemented a digital badge micro-credential for SCTR's Core Clinical Research Training (CCRT) course in collaboration with institution-wide education and technology offices. Beginning in January 2023, individuals were able to earn the CCRT Certified Digital Badge upon successful completion of the CCRT course.

Pilot implementation of a co-mentoring circles program for the clinical research professionals: Evidence for formative evaluation and logic model.

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.

Development and implementation of an on-demand competency-based onboarding program for clinical research professionals in academic medicine.

Over the past 7 years, Duke has implemented competency-based job classifications for clinical research professionals (CRPs) with a defined pathway for career advancement. The workforce is defined specifically as the collection of staff employed across the clinical research enterprise to operationalize clinical research and human participatory protocols through the hands-on conduct of protocol activities including participant enrollment, regulatory coordination, study documentation, data collection and management, and sponsor engagement. The competency framework for this critical workforce laid the foundation for a centrally developed on-demand onboarding program at Duke. The self-paced program is designed to engage learners through competency-based learning modules, guided mentor/manager discussions, and applied learning activities. Consisting of an initial E-Learning orientation to clinical research at Duke, called Express Start, followed by a 90-day role-based Onboarding Learning Plan, our onboarding program includes training in foundational pre-defined core competency areas and customizable learning paths. Associated Engagement Activity Packets for many clinical research competencies encourage mentor and/or manager involvement and hands-on learning for the employee through suggested enrichment activities. The program has been widely adopted for CRPs within the Duke University Schools of Medicine and Nursing, and newly hired CRPs and their managers have expressed satisfaction with these centrally offered tools. In this paper, we describe the methods used to develop and implement our competency-based onboarding program. We will share an evaluation of the program and planned next steps for expanding the suite of onboarding resources.

Reimagining the joint task force core competency framework for rural and frontier clinical research professionals conducting hybrid and decentralized trials.

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.

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

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, eMPACTTM (eMpowering Purposeful Advancement of Careers and Training). 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 project - conceptualization, task analysis for measurement development, algorithms development, algorithms validation, and system evaluation - presented specific goals and relevant methods. The results reported how the eMPACTTM 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. The eMPACTTM 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 eMPACTTM service to other CRP sectors.

Minding the gaps: assessing and addressing clinical research core competencies across a network of Canadian cancer centres.

The Canadian Cancer Clinical Trials Network (3CTN, the Network), established in 2014 to address the decline in academic cancer clinical trials' (ACCT) activity, has successfully achieved incremental year-over-year accrual targets as well as implemented recognized performance measures and supports for improving efficiency and quality of trial activities at member sites across Canada. As part of efforts to address ongoing challenges of staff recruitment, retention, and turnover in academic institutions that have been more recently exacerbated by the pandemic, the Network's Performance Strategy Sub-Committee (PSC) oversaw surveys of site clinical research professionals intended to capture workforce development status and identify knowledge gaps using the Joint Task Force Core Competency Framework (JTF CCF) as the standard basis for assessment. Accountable to the 3CTN Management Committee, the PSC consists of clinical research operations experts across Canada responsible for overseeing implementation and monitoring progress of this initiative. Staff at 3CTN's adult sites evaluated and reported trial personnel core competencies and gaps according to each domain/leveled competency statement of the framework. The most frequently noted competency gaps were in the domains of: Investigational Product Development and Regulation (28%); Scientific Concepts and Research Design (16%); and Study and Site Management (14%). Reported data was compiled and represented in the 3CTN Core Competency Report, developed as a web-based, interactive tool enabling members and stakeholders to filter data to enumerate and quantify workforce competency gaps at their site, within their node of affiliated sites, or across the national Network. Concurrently, an environmental scan and review of education resources was conducted and reviewed by the PSC. Embedded links to curated learning and development resources were incorporated into the report and associated with each domain/leveled competency statement to provide ready access to high-quality learning and development resources where needed. In the remaining years of its current strategic plan, 3CTN will continue to monitor, develop collaborative initiatives to target prioritized clinical research competency gaps and create opportunities for ongoing assessment and reporting by sites to capture changes in workforce core competencies over time.