Now is the time to fix the clinical research workforce crisis.

The clinical and translational research enterprise is recognized by many as the "evidence generation system." While there have been several calls to revolutionize this enterprise to more effectively deliver the fruits of biomedical science to patients and society, significant issues across the clinical research workforce are pervasive. Perhaps the most visible sign is the widening gap between supply and demand for competent staff. Underpinning this, is a perfect storm of complex issues. Now reaching crisis point, this problem is far bigger than a staffing issue and ultimately jeopardizes the "engine" of drug and device development. With the current perilous state of the workforce, proposed enterprise fixes are likely to languish far out of reach, given that even "business as usual" is under threat. In fact, a glaring disconnect is evident between the visionary discourse on how to revolutionize the clinical research enterprise and the sober recognition that operationalization of any such vision rests on the shoulders of a workforce that's in dire straits. In this article, we provide a brief forensic analysis of the workforce problem and an initial indication of where solutions may lie.

Rural-urban differences in health behaviors and outcomes among older, overweight, long-term cancer survivors in the RENEW randomized control trial.

PURPOSE: Rural cancer survivors (RCS) have poorer health outcomes and face multiple challenges-older age, and limited transportation, education, income, and healthcare access. Yet, RCS are understudied. The Reach-out to ENhancE Wellness(RENEW) trial, a home-based, diet and exercise intervention among 641 breast, prostate, and colorectal cancer survivors addressed many of these challenges. METHODS: We examined whether rural and urban participants differed in their response to the RENEW intervention (e.g., physical functioning, quality-of-life, intakes of fruits and vegetables (F&V) and saturated fat, body mass index(BMI), physical activity, and adverse events). RESULTS: Rural versus urban survivors report significantly more favorable mean (SE) changes in physical functioning [- 0.66 (1.47) v - 1.71 (1.00)], physical health [+ 0.14 (0.71) v - 0.74 (0.50)], and fewer adverse events [1.58 (0.08) v 1.64 (0.06)]. Rural versus urban survivors reported smaller increases in F&Vs [+ 1.47 (0.23) v + 1.56(0.16); p = 0.018], and lower percentages achieved goal behavior for endurance exercise and intakes of F&Vs and saturated fat. CONCLUSIONS: The RENEW intervention reduced declines in physical health and functioning among RCS to a significantly greater extent than for urban cancer survivors. All survivors significantly improved intakes of F&V and saturated fat, and endurance exercise; however, lower percentages of rural versus urban survivors met goal suggesting that more intensive interventions may be needed for RCS.

Effects of diet and exercise on weight-related outcomes for breast cancer survivors and their adult daughters: an analysis of the DAMES trial.

PURPOSE: Few trials have aimed to promote diet and exercise behaviors in both cancer survivors and their family members and examine their associations with weight-related outcomes. We conducted a secondary analysis to examine associations between change in diet and exercise behaviors and weight-related outcomes for overweight breast cancer survivors and their overweight adult daughters in the Daughters And MothErS Against Breast Cancer (DAMES) randomized trial. METHODS: The DAMES trial assessed the impact of two iteratively tailored, mailed print diet and exercise interventions against standard brochures over a 12-month period. This analysis examined change in diet and exercise behaviors and weight-related variables from baseline to post-intervention for the 50 breast cancer survivors and their adult daughters randomized to the intervention arms. To reduce the potential for type II error in this pilot, p values <0.10 were considered statistically significant. RESULTS: For mothers, change in diet quality was uniquely related to change in BMI (ß = -0.12, p = 0.082), weight (ß = -0.12, p = 0.060), and waist circumference (ß = -0.38, p = 0.001), whereas change in caloric intake was related to waist circumference (ß = 0.21, p = 0.002). For daughters, change in caloric intake was related to change in waist circumference (ß = 0.12, p = 0.055). However, change in diet quality was not associated with weight-related outcomes in daughters. Additionally, change in exercise was not associated with weight-related outcomes in mothers or daughters. CONCLUSIONS: Findings support mail-based and other tailored interventions for weight loss in this population, with an emphasis on diet quality for breast cancer survivors and caloric intake for their adult daughters.

Group trajectory analysis helps to identify older cancer survivors who benefit from distance-based lifestyle interventions.

BACKGROUND: The number of older cancer survivors is increasing as more adults survive to older ages. The objectives of this study were to examine trajectories of physical activity (PA) and physical function (PF) over a 2-year lifestyle counseling study and to identify characteristics of the trajectory groups. METHODS: This was a secondary analysis of Reach Out to Enhance Wellness, a randomized controlled trial of home-based lifestyle counseling. The 641 participants were older (≥65 years), overweight (body mass index [BMI], 25 to <40 kg/m(2)), long-term community-dwelling survivors (>5 years) of breast, prostate, and colorectal cancer from Canada, the United Kingdom, and the United States (21 states) who had been randomly assigned to an immediate intervention or a 12-month-wait-listed control arm. The main outcome measures were PA and PF trajectory group membership. RESULTS: Three PA groups and 5 PF trajectory groups were observed. The baseline BMI (P < .001) and self-efficacy for performing strength (P < .0001) and endurance exercises (P < .0002) were the strongest predictors of achieving the highest amount of PA and the most favorable functional trajectory over 2 years. Individuals with low baseline self-efficacy, no PA, and a Short Form 36 PF subscale score < 65 did not benefit from the intervention. CONCLUSIONS: This study identified characteristics of survivors who benefited from home-based interventions and suggested alternative approaches for survivors requiring more structured and intensive interventions to promote behavioral changes.

Cancer survivors' uptake and adherence in diet and exercise intervention trials: an integrative data analysis.

BACKGROUND: The health benefits of diet and exercise interventions for cancer survivors are well documented. However, little is known regarding demographic and medical predictors of survivors' willingness to participate in diet and exercise intervention trials, study enrollment, intervention adherence, and study completion. To assist in interpreting the generalizability of trial findings and to improve the design of future trials, this study examined predictors of these process measures. METHODS: An integrative data analysis was performed on data from 3 of the largest home-based diet and exercise intervention trials for cancer survivors (n = 23,841). Demographic and medical factors (ie, sex, race, age, time since diagnosis, and cancer type) were examined as predictors of willingness to participate, study enrollment, intervention adherence, and study completion in the pooled sample. A 99% confidence interval was used to determine statistical significance. RESULTS: Across trials, 11.1% of contacted survivors were willing to participate, and 5.7% were eligible and enrolled. Among enrollees, 53.4% demonstrated ≥75% adherence to the intervention, and 91.1% completed the study. Race (Caucasian vs others), age, time since diagnosis, and cancer type predicted survivors' willingness to participate (P < .01). All examined predictors were associated with the likelihood of study enrollment (P < .01). No significant predictors of intervention adherence or study completion were found among study enrollees (P ≥ .01). CONCLUSIONS: Cancer survivors' demographic and medical characteristics predicted their interest and participation in diet and exercise intervention trials. These findings have implications for the generalizability of results and can help to guide procedures used in future trials to enhance patient representation.

Daughters and Mothers Against Breast Cancer (DAMES): main outcomes of a randomized controlled trial of weight loss in overweight mothers with breast cancer and their overweight daughters.

BACKGROUND: Few studies to date have used the cancer diagnosis as a teachable moment to promote healthy behavior changes in survivors of cancer and their family members. Given the role of obesity in the primary and tertiary prevention of breast cancer, the authors explored the feasibility of a mother-daughter weight loss intervention. METHODS: A randomized controlled trial of a mailed weight loss intervention was undertaken among 68 mother-daughter dyads (n = 136), each comprised of a survivor of breast cancer (AJCC stage 0-III) and her adult biological daughter. All women had body mass indices ≥ 25 kg/m(2) and underwent in-person assessments at baseline, 6 months, and 12 months, with accelerometry and exercise capacity performed on a subset of individuals. All women received a personalized workbook and 6 newsletters over a 1-year period that promoted weight loss; exercise; and a nutrient-rich, low-energy density diet. A total of 25 dyads received individually tailored instruction (individual), 25 dyads received team-tailored instruction (TEAM), and 18 dyads received standardized brochures (control). RESULTS: The trial met its accrual target, experienced 90% retention, and caused no serious adverse events. Significant differences in baseline to 12-month changes were observed between individual versus control mothers for body mass index, weight, and waist circumference (WC); significant differences also were observed in the WC of corresponding daughters (P < .05). Significant differences were found between individual versus control and team versus control dyads for WC (P = .0002 and .018, respectively), minutes per week of physical activity (P = .031 and .036, respectively), and exercise capacity (P = .047 for both). CONCLUSIONS: Significant improvements in lifestyle behaviors and health outcomes are possible with tailored print interventions directed toward survivors of cancer and their family members. For greater impact, more research is needed to expand this work beyond the mother-daughter dyad.

Accuracy of 30-day recall for components of sexual function and the moderating effects of gender and mood.

INTRODUCTION: Despite the ubiquity of 1-month recall periods for measures of sexual function, there is limited evidence for how well recalled responses correspond to individuals' actual daily experiences. AIM: To characterize the correspondence between daily sexual experiences and 1-month recall of those experiences. METHODS: Following a baseline assessment of sexual functioning, health, and demographic characteristics, 202 adults from the general population (101 women, 101 men) were recruited to complete daily assessments of their sexual function online for 30 days and a single recall measure of sexual function at day 30. MAIN OUTCOME MEASURES: At the baseline and 30-day follow-ups, participants answered items asking about sexual satisfaction, sexual activities, interest, interfering factors, orgasm, sexual functioning, and use of therapeutic aids during the previous 30 days. Participants also completed a measure of positive and negative affect at follow-up. The main outcome measures were agreement between the daily and 1-month recall versions of the sexual function items. RESULTS: Accuracy of recall varied depending on the item and on the gender and mood of the respondent. Recall was better (low bias and higher correlations) for sexual activities, vaginal discomfort, erectile function, and more frequently used therapeutic aids. Recall was poorer for interest, affectionate behaviors (e.g., kissing), and orgasm-related items. Men more than women overestimated frequency of interest and masturbation. Concurrent mood was related to over- or underreporting for six items addressing the frequency of masturbation and vaginal intercourse, erectile function, and orgasm. CONCLUSIONS: A 1-month recall period seems acceptable for many aspects of sexual function in this population, but recall for some items was poor. Researchers should be aware that concurrent mood can have a powerful biasing effect on reports of sexual function.

Diet and exercise intervention adherence and health-related outcomes among older long-term breast, prostate, and colorectal cancer survivors.

BACKGROUND: Diet and exercise interventions for cancer survivors result in health benefits; however, few studies have examined health outcomes in relation to adherence. PURPOSE: We examined associations between adherence to components of a diet-exercise intervention and survivors' physical and mental health. METHODS: A randomized controlled trial tested a telephone and mailed print intervention among 641 older, overweight, long-term survivors of breast, prostate, and colorectal cancer. Dietary and exercise behaviors were assessed at 14 time points throughout the year-long intervention; health outcomes were examined postintervention. RESULTS: Telephone session attendance had significant indirect relationships with health outcomes through intervention-period exercise and dietary behavior. Attendance showed positive indirect relationships with physical function (ß = 0.11, p < 0.05), basic and advanced lower extremity function (ß = 0.10, p < 0.05/ß = 0.09, p < 0.05), and mental health (ß = 0.05, p < 0.05), and a negative indirect relationship with body mass index (ß = -0.06, p < 0.05). CONCLUSIONS: Session attendance is vital in facilitating improvement in health behaviors and attendant outcomes (Clinicaltrials.gov number NCT00303875).

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.

A Method for Efficient De-identification of DICOM Metadata and Burned-in Pixel Text.

De-identification of DICOM images is an essential component of medical image research. While many established methods exist for the safe removal of protected health information (PHI) in DICOM metadata, approaches for the removal of PHI "burned-in" to image pixel data are typically manual, and automated high-throughput approaches are not well validated. Emerging optical character recognition (OCR) models can potentially detect and remove PHI-bearing text from medical images but are very time-consuming to run on the high volume of images found in typical research studies. We present a data processing method that performs metadata de-identification for all images combined with a targeted approach to only apply OCR to images with a high likelihood of burned-in text. The method was validated on a dataset of 415,182 images across ten modalities representative of the de-identification requests submitted at our institution over a 20-year span. Of the 12,578 images in this dataset with burned-in text of any kind, only 10 passed undetected with the method. OCR was only required for 6050 images (1.5% of the dataset).

Methods for building a staff workforce of quantitative scientists in academic health care.

Collaborative quantitative scientists, including biostatisticians, epidemiologists, bio-informaticists, and data-related professionals, play vital roles in research, from study design to data analysis and dissemination. It is imperative that academic health care centers (AHCs) establish an environment that provides opportunities for the quantitative scientists who are hired as staff to develop and advance their careers. With the rapid growth of clinical and translational research, AHCs are charged with establishing organizational methods, training tools, best practices, and guidelines to accelerate and support hiring, training, and retaining this staff workforce. This paper describes three essential elements for building and maintaining a successful unit of collaborative staff quantitative scientists in academic health care centers: (1) organizational infrastructure and management, (2) recruitment, and (3) career development and retention. Specific strategies are provided as examples of how AHCs can excel in these areas.

Improving eSource Site Start-Up Practices.

Background: eSource software that copies patient electronic health record data into a clinical trial electronic case report form holds promise for increasing data quality while reducing data collection, monitoring and source document verification costs. Integrating eSource into multicenter clinical trial start-up procedures could facilitate the use of eSource technologies in clinical trials. Methods: We conducted a qualitative integrative analysis to identify eSource site start-up key steps, challenges that might occur in executing those steps, and potential solutions to those challenges. We then conducted a value analysis to determine the challenges and solutions with the greatest impacts for eSource implementation teams. Results: There were 16 workshop participants: 10 pharmaceutical sponsor, 3 academic site, and 1 eSource vendor representatives. Participants identified 36 Site Start-Up Key Steps, 11 Site Start-Up Challenges, and 14 Site Start-Up Solutions for eSource-enabled studies. Participants also identified 77 potential impacts of the Challenges upon the Site Start-Up Key Steps and 70 ways in which the Solutions might impact Site Start-Up Challenges. The most important Challenges were: (1) not being able to identify a site eSource champion and (2) not agreeing on an eSource approach. The most important Solutions were: (1) vendors accepting electronic data in the FHIR standard, (2) creating standard content for eSource-related legal documents, and (3) creating a common eSource site readiness checklist. Conclusions: Site start-up for eSource-enabled multi-center clinical trials is a complex socio-technical problem. This study's Start-Up Solutions provide a basic infrastructure for scalable eSource implementation.

Long-term outcomes of the FRESH START trial: exploring the role of self-efficacy in cancer survivors' maintenance of dietary practices and physical activity.

BACKGROUND: This study examined whether changes in self-efficacy explain the effects of a mailed print intervention on long-term dietary practices of breast and prostate cancer survivors. The relationship between change in self-efficacy and long-term physical activity (PA) also was examined. METHODS: Breast and prostate cancer survivors (N = 543) from 39 US states and two Canadian provinces participated in the FRESH START intervention trial. Participants were randomly assigned to receive a 10-month program of mailed print materials on diet and PA available in the public domain or a 10-month program of tailored materials designed to increase fruit and vegetable (F&V) intake, decrease fat intake, and/or increase PA. Changes in self-efficacy for F&V intake and fat restriction were analyzed as potential mediators of the intervention's effects on diet at 2-year follow-up. Because we previously found that change in self-efficacy for PA did not vary by group assignment, the relationship between change in self-efficacy and PA at 2-year follow-up was examined across study conditions. RESULTS: Results suggest that change in self-efficacy for fat restriction partially explained the intervention's effect on fat intake (mean indirect effect = -0.28), and change in self-efficacy for F&V consumption partially explained the intervention's effect on daily F&V intake (mean indirect effect = .11). Change in self-efficacy for fat restriction partially accounted for the intervention's impact on overall diet quality among men only (mean indirect effect = 0.60). Finally, change in self-efficacy for PA predicted PA at 2-year follow-up. CONCLUSIONS: Findings suggest that self-efficacy may influence long-term maintenance of healthy lifestyle practices among cancer survivors.

Tackling standardization in clinical research workforce hiring using competency-based job classifications.

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.

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.

Leveraging retooled clinical research infrastructure for Clinical Research Management System implementation at a large Academic Medical Center.

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.

Extant health behaviors and uptake of standardized vs tailored health messages among cancer survivors enrolled in the FRESH START trial: a comparison of fighting-spirits vs fatalists.

OBJECTIVE: Cancer coping styles have been associated with several cancer-related outcomes. We examined whether baseline lifestyle behaviors differed between cancer survivors with fatalistic vs fighting-spirit coping styles, and whether there was differential response to two diet-exercise mailed-print interventions, one standardized and another individually tailored. METHODS: Baseline differences by coping style are presented for 628 breast and prostate cancer survivors who participated in the FRESH START trial, along with multivariable analyses on rates of uptake by coping style and arm assignment for those completing the 2-year trial. RESULTS: At baseline, several differences were observed between fighting-spirits and fatalists, with the former significantly more likely to be white, younger, leaner, more-educated and at risk for depression, and less likely to consume 5+fruits and vegetables (F&V)/day (p-values<0.05). Improvements in physical activity were observed, with fighting-spirits exhibiting the greatest gains from baseline to Year-1, regardless of intervention type; but by Year-2, these differences diminished as fatalists gained ground. Moreover, fatalists who received standardized intervention material also charted steady improvements in F&V intake over the study period; by Year-2, 58.1% of fatalists achieved the 5-a-day goal vs 44.6% of fighting-spirits (p-value<0.05). CONCLUSIONS: Lifestyle behaviors and health message uptake differs by cancer coping style. Although tailored interventions appear most effective and minimize differential uptake, standardized interventions also can improve behaviors, though fighting-spirits may require additional boosters to maintain change.

Long-term physical activity outcomes of home-based lifestyle interventions among breast and prostate cancer survivors.

PURPOSE: Few studies have investigated long-term effects of physical activity (PA) interventions. The goal of this study was to evaluate whether or not increased levels of moderate to vigorous physical activity (MVPA) were maintained by cancer survivors 1 year after receipt of two home-based interventions. METHODS: The FRESH START trial randomized 543 breast and prostate cancer survivors to 1-of-2 mailed print diet and exercise interventions: sequentially-tailored vs. standardized (attention control). Each arm received eight mailings over a 1-year period, with follow-up at 1 and 2 years. This analysis focuses solely on the 400 participants who had suboptimal levels of MVPA at baseline (measured by the 7-Day Physical Activity Recall) and who completed the 2-year study. RESULTS: Median minutes of MVPA at baseline, 1-year and 2-year follow-up in the tailored intervention arm were as follows: 0, 90, and 60 min/week, respectively. The corresponding values in the attention control group were 0, 30, and 30 min/week. Significant improvements in MVPA from baseline to 2-year follow-up were observed in both study arms (p < 0.01). While significant between-arm differences were observed at 1-year follow-up (p < 0.01), there was only the suggestion of a trend (p = 0.08) at 2-year follow-up. CONCLUSIONS: This study provides evidence that mailed-print exercise interventions result in significant and sustainable improvements in MVPA among newly diagnosed cancer survivors that are observed well after the intervention is complete. While tailored interventions, as compared to standardized materials, appear to produce superior improvements in MVPA initially, these differences diminish over time.

Development and evaluation of a novel training program to build study staff skills in equitable and inclusive engagement, recruitment, and retention of clinical research participants.

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.

Issues for recruitment and retention of clinical research professionals at academic medical centers: Part 1 - collaborative conversations Un-Meeting findings.

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.