Objectives/Goals: Clinical trial success requires recruiting and retaining diverse participants. The ER&R Certificate Program trains clinical research professionals (CRPs) in equity, diversity, and inclusion (EDI), addressing biases, and integrating regulatory knowledge with practical skills to foster inclusive research practices. Methods/Study Population: An interdisciplinary Steering Committee, supported by Duke CTSI and DOCR, developed and implemented an engagement, recruitment, and retention certificate program (ER&R) for CRPs. With expert-led instruction, including e-learning, group sessions, and hands-on activities, ER&R integrates EDI into participant engagement practices. Participants complete 7 core courses and at least 3 elective courses, reflecting their unique responsibilities. Program evaluation uses the Kirkpatrick model to assess participant learning, competency, and EDI integration into clinical research. Since launch, the program has expanded to include clinical research trainees from Durham Technical Community College. All elements of the program were designed to allow for sharing across academic medical institutions. Results/Anticipated Results: A total of 202 CRPs and trainees have participated since launch (2020), including 17 trainee participants from Durham Technical Community College (2022–2024). Post-program evaluations showed significant growth in recruitment and retention self-efficacy. An early evaluation of the first 2 cohorts (n = 59) included a self-assessment across defined competencies showing marked increases in comfort across all learning objectives, with notable gains in: Community and Stakeholder Engagement, Recruitment on a Shoestring Budget, Community-Engaged Research Initiatives, and Social Marketing. Participants valued the program’s focus on EDI and sought more practical strategies and peer collaboration. 50 additional institutions have engaged with our implementation consultations and program repository. Discussion/Significance of Impact: Barriers to equitable ER&R exist at the individual, study, and system levels. Addressing these requires more intentional engagement practices. The ER&R certificate program is an innovative model for integrating equity principles with practical and required knowledge and skills training for participant-facing research professionals.

Objectives/Goals: Clinical research professional (CRP) managers often struggle to onboard effectively in the rapid timelines necessary. We developed a competency-based, standardized, onboarding program using a 3-factor adult learning approach and designed to be easily adaptable, broadly shared, and readily implemented across a variety of research environments. Methods/Study Population: The Duke competency-based onboarding program for CRPs was developed through an iterative process with input from research community members. Initially, 97 courses were mapped to clinical research competencies using the Joint Taskforce for Clinical Trial Competency framework to identify training gaps and establish a structured learning framework. The onboarding program includes three key components: role specific Express Start modules (self-paced e-learning), Onboarding Learning Plans (a customizable timeline for competency-mapped trainings), and Engagement Activity Packets (guides for manager-driven applied learning in specific competency areas). An additional cohort-based mentorship program (RPN+) includes 4 months of mentored group learning and seminars designed for new professionals. Results/Anticipated Results: Since launch in 2021, 521 new employees have registered an Onboarding Learning Plan representing more than 55% of new CRPs. Additionally, nearly 85% of new CRPs have completed the Express Start role-specific online modules. 54% of new CRPs have enrolled in RPN+ (launched in 2022) and have included members from 22 of 24 clinical research units. Users have reflected the range of clinical research staff roles at Duke, with the majority being clinical research coordinators. A significant predominance of participants found the programs beneficial and would recommend to others. Since launch, program materials have been shared with 64 external groups and institutions via 91 requests. Discussion/Significance of Impact: Duke’s CRP onboarding program addresses organizational, technical, and social aspects through Express Start, Onboarding Learning Plans, and the RPN+ mentoring program. Aligned with the JTFCTC framework, and designed for broad implementation, it successfully promotes competency-based growth and optimizes time for both managers and employees.

Objectives/Goals: The primary objectives of this project were to create a user-friendly website that • Shares details of ongoing studies in an easily searchable and filterable format. • Provides lay summaries of study results. • Highlights our volunteer registry. • Offers a platform for community engagement and feedback on research interests. Methods/Study Population: The website, developed using DRUPAL 10 and launched in June 2024, was created with input from faculty, staff, research participants, and community partners. It targets potential participants, community members, providers, and other Academic Medical Centers. The development process included focus groups to identify design and feature needs, design iterations and usability testing, and an external accessibility review. Study information is automatically updated from the Study Information Portal (SIP) in OnCore and a custom REDCap survey. Features include a research volunteer registry, study results in lay terms, educational content about research, and multiple ways for community engagement. The site supports English and Spanish and follows best practices for accessibility. Results/Anticipated Results: Community feedback on the site has been very positive, with positive comments about ease of navigation and the improved appearance of the website. It is still early, but we have seen a notable increase in enrollment in the Volunteer Registry since the launch of the website. We track referral sources for the registry, and to date, we have seen 98 individuals enrolled who were directed to us through the website since it launched. This equates to an average of 5 people a week, more than any other referral source. This rate increases to almost 7 per week if we look solely at the period since we started the promotion of the website in early August. As the site awareness expands, we will also be getting feedback from individual studies and are tracking email communication generated from the site as well. Discussion/Significance of Impact: The development of this website represents a significant step toward improving community engagement in clinical research at Duke. By providing a centralized platform for study information, results, and community feedback, we aim to foster a more informed and involved participant base, ultimately enhancing the impact and reach of our research.

The potential for physicians, clinicians, and health professionals to contribute to the advancement of medical therapies through clinical research is significant. Yet, a lack of exposure to, or practical training in, the conduct of clinical research can inhibit health profession trainees from considering research careers, thus perpetuating the already limited influx of new talent. To enhance the sustainability of career pathways into research for all trainees, including those from traditionally underrepresented communities, trainees must experience early exposure to research concepts through robust training and hands-on opportunities. In 2015, the Duke Office of Clinical Research created a Research Immersion elective for Duke’s Master in Biomedical Sciences program, which prepares students for additional health professional training. The course trained students through didactic and practical experiences, with a unique interprofessional mentorship team including both principal investigator and clinical research professional mentors. Following eight cohorts of iterative course optimization, students’ confidence increased in all 24 research competencies assessed. A cross-sectional analysis of post-course outcomes in May 2024 revealed 40.4% of students had continued in research after the program and 60.6% had continued their health professions education. We attributed this success to applied learning and clear expectations and guidelines to support the mentor-student relationship.

While clinical research intends to improve health outcomes for all, access to research participation is often limited and inequitable. Geographic proximity is a recognized barrier, thus, systemic infrastructure solutions through federal programs including General Clinical Research Centers and Clinical and Translational Science Awards have sought to improve accessibility. Even with such support, academic medical centers often have limited clinical research-dedicated space apart from shared exam rooms in difficult-to-navigate hospitals or clinics. In 2019, the Duke University School of Medicine looked beyond its medical center campus to identify free-standing sites within Durham communities for participant study visits. Catalyzed by the COVID-19 pandemic, Duke Research at Pickett, a 22 000-square-foot building with a laboratory, 30 exam rooms, and on-site parking, opened in October 2020 to support vaccine and treatment trials. Upon the lifting of many COVID-19 restrictions, and in partnership with the Research Equity and Diversity Initiative (READI) Community Advisory Council, the building was transformed to encourage community gatherings, education, and training programs. To date, Duke Research at Pickett has hosted 2692 participants in 78 research trials and 14 community-engaged activities.

OBJECTIVES/GOALS: Identify causes for clinical research professional turnover Define data collection methods for exit interviews Provide institutions with resources to collect and analyze exit interviews Employ strategies to maximize the impact of exit interviews on retention METHODS/STUDY POPULATION: The Clinical Research Professional Taskforce (CRPT) exit interview Subgroup has met monthly since January 2023. Action items were agreed to and minutes were kept and reviewed at subsequent virtual working meetings. All members were given opportunity to speak and contribute. After a landscape analysis, conducted via survey, five institutions agreed to provide examples of their exit interview questions. Members spoke at length about goals, methods, collection techniques, institutional involvement, lessons learned and practical applications that could become best practices. RESULTS/ANTICIPATED RESULTS: The Subgroup aggregated all questions into categories and developed sample questions incorporating all data without using any word for word. In order to allow for quantitative assessment and standardized reporting the Subgroup formulated questions to be responded to utilizing a Likert scale with free text fields for select questions where further information is needed. The Subgroup developed best practices describing decision-making metrics, understanding reasons for turnover and reporting data back to leadership. Practical aspects such as method and time of survey collection, anonymity, and training staff are also included. DISCUSSION/SIGNIFICANCE: We are hopeful that sample questions and best practices will be helpful and widely utilized. Understanding the causes and impacts of CRP turnover are critical to meeting the current needs of clinical research. Further work is being done to calculate the cost of turnover to make the business case.

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.

Quality clinical research is essential for health care progress and is the mission of academic health centers. Yet ensuring quality depends on an institution’s ability to measure, control, and respond to metrics of trial performance. Uninformed clinical research provides little benefit to health care, drains institutional resources, and may waste participants' time and commitment. Opportunities for ensuring high-quality research are multifactorial, including training, evaluation, and retention of research workforces; operational efficiencies; and standardizing policies and procedures. Duke University School of Medicine has committed to improving the quality and informativeness of our clinical research enterprise through investments in infrastructure with significant focus on optimizing research management system integration as a foundational element for quality management. To address prior technology limitations, Duke has optimized Advarra’s OnCore for this purpose by seamlessly integrating with the IRB system, electronic health record, and general ledger. Our goal was to create a standardized clinical research experience to manage research from inception to closeout. Key drivers of implementation include transparency of research process data and generating metrics aligned with institutional goals. Since implementation, Duke has leveraged OnCore data to measure, track, and report metrics resulting in improvements in clinical research conduct and quality.

OBJECTIVES/GOALS: To address investigator frustration and appropriate oversight for student interns performing clinical research activities, we created infrastructure to support matchmaking with clinical research teams and onboarding of student interns, thereby allowing for more meaningful internship experiences with access to clinical research systems. METHODS/STUDY POPULATION: Internship requests may be initiated by a student, an affiliated institution, or an investigator. Requests are triaged accordingly. Affiliation agreements define the parameters for these placements. Unaffiliated institutions may request an agreement by contacting CRISP; otherwise, unaffiliated interns will be classified as visiting scholars with restricted access. If a student is from an affiliated institution, the Clinical Research Internship Portal (CRISP) is used to collect and track information regarding the internship. CRISP provides: Matchmaking for student interns with placements Compilation of onboarding documentation Tools (e.g., learning agreements) for student intern supervisors Professional development workshop series for all student interns RESULTS/ANTICIPATED RESULTS: Launched in 2021, CRISP is a relative newcomer to the Duke research training landscape, but preliminary impact may be measured by the following metrics: Affiliated institutions: 8 agreements in place, 4 pending 25 student interns from 7 institutions placed across 11 departments/institutes 7-session professional development series garnering positive feedback from interns and supervisors Improved access to clinical and research systems aligned with clinical research activities Enhanced oversight and tracking of student interns across Duke enterprise Expansion of program to include internal and external student interns CRISP has engaged invested parties within and outside of Duke to ensure robust oversight of these valuable training opportunities and to create new pathways into our workforce. DISCUSSION/SIGNIFICANCE: Streamlining intern placements has lessened pain points related to including students in our research environment, both for investigators and institutional partners. Future plans include expanding the number of affiliation agreements, creating an interface to quickly triage intern requests, and scaling up the professional development series.

OBJECTIVES/GOALS: In March 2019, Duke updated recruitment guidelines and adopted an “Engagement” policy that requires patients to ‘opt-out’ of communications regarding potential research participation. This created an opportunity to evaluate recruitment for ongoing clinical studies pre and post implementation. METHODS/STUDY POPULATION: Implementation of the new policy required new training for study teams, modification to recruitment plans, and expansion of ongoing efforts to improve direct-to-patient messaging through EPIC/MyChart tools. The impact of this new policy on overall recruitment was monitored and characterized both prior to and after implementation of the policy. Customized MyChart messages have been generated for over 22 studies, with a total of 41,386 messages sent to potential participants. RESULTS/ANTICIPATED RESULTS: Only a small number of study teams have modified their recruitment plans with transition to the new policy. This may be related to lack of understanding about policy implementation, potential recruitment opportunities, required training, resource limitations, etc. However, our case study, TMIST, had an 48% improvement in average enrollment within the first 2 months of implementation, and an almost 40% improvement in recruitment efficiency. Since becoming an “opt-out” institution, 11 study teams have implemented direct-to-patient recruitment via the MyChart patient portal. One unintended consequence we’ve noted is several different study invitations to potential participants within some patient populations. DISCUSSION/SIGNIFICANCE OF IMPACT: The new policy allows study teams to engage in direct-to-patient outreach, leading to an increase in enrollment for some studies. Incorporation of direct-to-patient messaging strategies can be a cost and resource saving measure to improve recruitment. The need to recruit similar populations demonstrated that strategic, thoughtful approaches are needed.

OBJECTIVES/SPECIFIC AIMS: 1.Assess changes in clinical research workforce landscape at Duke 2.Optimize and evaluate efficacy of a tier advancement process for clinical research career progression at Duke 3.Implement CRP engagement as a change management mechanism for workforce innovation METHODS/STUDY POPULATION: We evaluated 857 clinical research positions at Duke to understand changes in the workforce (demographics, numbers in each position and tier) since implementing the tier advancement process in 2016. To understand the efficacy of the tier assessment process, data from a subset of this population (n=84) who underwent the advancement process was examined for success rate. Individual employees and their managers were surveyed to understand their perception of the advancement process and identify areas for improvement. We also describe implementation of multiple mechanisms of community engagement to manage expectations around the tier advancement process and to provide opportunities for employees to self-manage their career planning, including portfolio planning and leadership opportunities. RESULTS/ANTICIPATED RESULTS: Whereas the clinical research workforce has grown by 5.5% since tiering began (2016, n=810; 2018 n=857). Nearly 13% of that growth has been in managerial or senior positions (2016, n=111; 2018 n=127). Distributions across job classifications changed only slightly, representing realignment of positions with study-level responsibilities over department-level responsibilities. Notably, clinical research nurses (CRNC & CRNC Sr.) was the only category including tiered and non-tiered positions to drop overall numbers between 2016 (n = 136) and 2018 (n=115), representing a shift in the workforce from research nurses to research coordinators. General demographics (gender, age) remained largely the same. A total of 359 positions have been hired during this time frame, nearly half of which were entry-level positions (175/359): 47 of these positions represent expansion of the workforce. Of 359 new hires since 2016, 271 currently still work in one of the research roles. Of the 84 employees who underwent the tier advancement process, 84% (43/51) succeeded in tier 2 advancement, 70% (14/20) succeeded in tier 3 advancement (CRC, CRNC, and regulatory coordinators), and 77% (10/13) of research program leaders (RPLs) succeeded in achieving tier two, which is the highest tier for this group. Fifty-five employees (65%) and 32 managers responded to a voluntary feedback survey. Overall confidence in the process improved in both groups from 2016 to 2018, most notably with managers. Both groups indicated a 10 hour reduction (employees = 35hr, 2016 and 25hr 2018; managers 25hr, 2016 and 15hr 2018) in time required to complete the tier advancement process. DISCUSSION/SIGNIFICANCE OF IMPACT: The use of objectively-assessed competencies is an important step in the development of a workforce. By 1) maintaining alignment with industry standards for competencies, 2) upholding high standards, and 3) offering a consistent approach to career growth, Duke is working to develop and maintain a workforce that supports high quality research. Since the implementation of standardized job classifications and competency-based tier advancement, the positions have undergone rigorous competency-based needs evaluation. This leads to better matched jobs to study needs as well as increased standardization across the clinical research workforce. We believe that the subtle workforce shifts represent alignment of our positions with the business needs of our clinical research enterprise. Additionally, approximately 15% of our clinical research workforce has taken advantage of the opportunity to advance their own careers. We have made significant improvements in the following tier advancement processes: standardization of assessments, scoring guides, and modes; changes from LMS to a REDCap delivery of the knowledge assessments; streamlined the utilization of electronic documentation; and additional guidance for employees and managers regarding portfolio inclusions. These improvements have increased satisfaction and acceptance with the advancement process and were made possible through strategic communication across the workforce. Regular town hall meetings and focus group feedback sessions have included the clinical research community in discussions of WE-R initiatives and provided a much-needed feedback loop for process improvement and change management. Moreover, inclusion of WE-R discussion in our Research Professional Network events has provided opportunities to discuss career advancement strategies as well as volunteer opportunities to grow and demonstrate leadership competencies.

OBJECTIVES/SPECIFIC AIMS: Describe the framework for tier advancement of research professionals. Describe the various forms of assessments of competencies. How competencies are used to provide transparency into professional development opportunities. Discuss the results of the first tier advancement opportunity for research staff. METHODS/STUDY POPULATION: These processes were developed at Duke, an academic medical center with over 2000 active clinical research protocols and 300 new clinical trials per year. Roughly 500 employees are categorized into tiered classifications, allowing them opportunities for advancement through competency testing. Approximately 10% opted for tier testing, and their results will be shared. RESULTS/ANTICIPATED RESULTS: Competency assessments were developed for all 42 of Duke’s research professional competencies, some using 2 modalities of testing. Almost 12% of the research professionals classified in tiered positions opted to attempt the tier advancement process. Of those, 37 completed, and the vast majority reached their desired tier. Results by competency will be provided. DISCUSSION/SIGNIFICANCE OF IMPACT: The use of objectively assessed competencies is an important step in the development of a workforce. By (1) maintaining alignment with industry standards for competencies, (2) holding staff to a high bar, and (3) offering a consistent approach to career growth, Duke is working to develop and maintain a workforce that supports high quality research.

OBJECTIVES/SPECIFIC AIMS: Describe the process used to develop job descriptions and how this translates into consistent hiring practices. Describe how competencies are used to provide transparency into professional development opportunities. Discuss planned incorporation of competencies into efforts to train the clinical research workforce. METHODS/STUDY POPULATION: These processes were developed at Duke, an academic medical center with over 2000 active clinical research protocols and 300 new clinical trials per year. Over 1000 employees were evaluated for mapping into clinical research positions, with 685 mapping into new research positions (makeup of workforce to be depicted). RESULTS/ANTICIPATED RESULTS: Prior to this initiative, the clinical research workforce was not well-defined. Through the mapping process, employees were mapped from over 80 different positions into 10 (figure), resulting in a workforce that allows for visible career ladders and greater opportunity for development. As the initiative evolves and grows to include competency-driven performance evaluations, training modules, and assessments, we anticipate the ability to see the relationship between the competencies and high-quality clinical research support. DISCUSSION/SIGNIFICANCE OF IMPACT: The use of competencies in the context of workforce development is not new, yet in clinical research, they provide a much-needed framework for an ever-evolving profession. This comprehensive use of competencies throughout a workforce development initiative is key to ensuring strong support of high-quality clinical research.

OBJECTIVES/SPECIFIC AIMS: Our objectives are to provide opportunities for graduate students, clinical interns, and postdoctoral fellows in traditional training programs to have immersive experiences in clinical research conduct from a CRP perspective. In addition, we aimed to address common causes of job dissatisfaction by providing professional development and networking opportunities for the existing CRP workforce. METHODS/STUDY POPULATION: In collaboration with the CTSA workforce development group, the Duke Office of Clinical Research hosted a site visit for 19 PhD scientists interested in nontraditional career pathways and a short lecture series on project management careers in clinical research. Additionally, we crafted specific clinical research training electives for 20 masters students and 10 dietetic interns. Finally, in collaboration with UNC-CH, we combined Research Professional Networks to provide a pilot joint professional development event for 109 CRPs from both schools. RESULTS/ANTICIPATED RESULTS: The number of Masters students enrolling in the CRP elective grew from 7 students in year 1 to 13 students currently enrolled. A retro-pre/postprogram adapted CRAI survey was issued following program completion. Students self-reported increases in competence across all 24 skills measured. Largest increases were seen in areas specific to CRP roles such as consenting patients, understanding the IRB, and reviewing key study documents. A baseline culture survey issued at the joint Duke/UNC CRP event garnered a 65% response rate and indicated that the principal gaps in professional training are in communications, teamwork, leadership, and professionalism. Moreover, respondents indicated that creating a sense of community and providing networking opportunities were the most important outcomes for future CRP collaborations. Future evaluations of both of these programs will allow us to tailor training to be most effective in strengthening our CRP workforce. DISCUSSION/SIGNIFICANCE OF IMPACT: These initiatives lay the groundwork for the development of a robust training pipeline into CRP careers. Future initiative will apply lessons learned toward creating internship programs aimed at improving diversity and inclusion within these careers. In addition, by addressing the professional development needs of the existing workforce, we create a sustainable environment for well-trained professionals. By evaluating these primary initiatives, we can better define the critical elements that must be included in CRP educational, development, and support programs and subsequently apply these to ultimately improve the clinical and translational research being conducted in academic research settings.