Clinical Research Coordinators (CRCs) are key members of research teams who ensure rigorous conduction of clinical studies and quality standard compliance. Yet, their roles and responsibilities are still not well defined, and formal recognition of their professional profile is lacking in Italy. This survey of Italian healthcare institutions collected data on centers’ research activities number of CRCs and tasks they performed and explored factors associated with CRC employment.

Cross-sectional study using a brief questionnaire. Data were analyzed by means of graphical representations, histogram, scatter, and polar plots. Multivariable linear regression was specified to test the association between the number of CRCs and a subset of factors.

Data collection took place from February to December 2020. 62/143 institutions (43.4%) responded. Median number of ongoing studies reported by centers was 65 (IQR 29–205); of these, median of sponsored and interventional studies was 32 and 35, respectively. Median number of CRCs employed at each center was 6 (IQR 2–9). The frequency with which activities were reported to be performed by CRCs overlapped with those of Data Managers. Linear multivariable regression analysis revealed a statistically significant association between the number of employed CRCs and the number of sponsored studies (P = 0.01), but not with the total number of studies, geographical location, or institution type.

The association between industry funding and the number of CRCs observed in this study should be further explored to understand the direction of this relationship and to verify whether this may influence compliance with quality standards.

The lack of diversity in health research participation has serious consequences for science as well as ethics. While there is growing interest in solving the problem, much of the work to date focuses on attitudes of distrust among members of underrepresented communities. However, there is also a pressing need to understand existing barriers within the cultural and structural context of researchers and research staff.

This study adopted a sequential exploratory mixed-methods design to allow for a focused examination of barriers to inclusive research recruitment among researchers and staff. Barriers first identified from an initial quantitative investigation (web-based survey; n = 279) were further explored through qualitative methods (key informant interviews; n = 26). Participants were investigators and research team members in both phases of the study.

The survey revealed a paradoxical disconnect between participants’ reported belief in the abstract value of diversity in research participation (87.1% important/extremely important) and belief in it as an important goal in their own specific research (38.3% important/extremely important). Interviews reveal that researchers and staff perceive many barriers to the recruitment of members of underrepresented groups and hold a general view of diversity in research as an impractical, even unattainable, goal.

It is crucial that principal investigators not only understand the consequences of the continued exclusion of marginalized groups from research but also implement strategies to reverse this trend and communicate with research staff on the issue. While individual bias does play a role (ex: a priori assumptions about the willingness or ability of members of underrepresented groups to participate), these behaviors are part of a larger context of systemic racism.

The National Institutes of Health launched the NIH Centers for Accelerated Innovation and the Research Evaluation and Commercialization Hubs programs to develop approaches and strategies to promote academic entrepreneurship and translate research discoveries into products and tools to help patients. The two programs collectively funded 11 sites at individual research institutions or consortia of institutions around the United States. Sites provided funding, project management, and coaching to funded investigators and commercialization education programs open to their research communities.

We implemented an evaluation program that included longitudinal tracking of funded technology development projects and commercialization outcomes; interviews with site teams, funded investigators, and relevant institutional and innovation ecosystem stakeholders and analysis and review of administrative data.

As of May 2021, interim results for 366 funded projects show that technologies have received nearly $1.7 billion in follow-on funding to-date. There were 88 start-ups formed, a 40% Small Business Innovation Research/Small Business Technology Transfer application success rate, and 17 licenses with small and large businesses. Twelve technologies are currently in clinical testing and three are on the market.

Best practices used by the sites included leadership teams using milestone-based project management, external advisory boards that evaluated funding applications for commercial merit as well as scientific, sustained engagement with the academic community about commercialization in an effort to shift attitudes about commercialization, application processes synced with education programs, and the provision of project managers with private-sector product development expertise to coach funded investigators.

A national survey characterized training and career development for translational researchers through Clinical and Translational Science Award (CTSA) T32/TL1 programs. This report summarizes program goals, trainee characteristics, and mentorship practices.

A web link to a voluntary survey was emailed to 51 active TL1 program directors and administrators. Descriptive analyses were performed on aggregate data. Qualitative data analysis used open coding of text followed by an axial coding strategy based on the grounded theory approach.

Fifty out of 51 (98%) invited CTSA hubs responded. Training program goals were aligned with the CTSA mission. The trainee population consisted of predoctoral students (50%), postdoctoral fellows (30%), and health professional students in short-term (11%) or year-out (9%) research training. Forty percent of TL1 programs support both predoctoral and postdoctoral trainees. Trainees are diverse by academic affiliation, mostly from medicine, engineering, public health, non-health sciences, pharmacy, and nursing. Mentor training is offered by most programs, but mandatory at less than one-third of them. Most mentoring teams consist of two or more mentors.

CTSA TL1 programs are distinct from other NIH-funded training programs in their focus on clinical and translational research, cross-disciplinary approaches, emphasis on team science, and integration of multiple trainee types. Trainees in nearly all TL1 programs were engaged in all phases of translational research (preclinical, clinical, implementation, public health), suggesting that the CTSA TL1 program is meeting the mandate of NCATS to provide training to develop the clinical and translational research workforce.

In an era of complex, multi-institutional, team-based science, there is little guidance for the successful creation of effective, collaborative, multisite training programs.

We designed, implemented, and evaluated a multi-institutional Tobacco Regulatory Science (TRS) fellowship representing a scalable program that may be customized for other research areas.

Using a mixed-methods approach, we analyzed program evaluations from trainees enrolled in the first 7 years of the American Heart Association (AHA) Tobacco Regulation and Addiction Center (A-TRAC) fellowship (2014–2021). We also reported the program outcomes, including published TRS manuscripts, independent grant funding, Food and Drug Administration (FDA) Docket comments submitted on TRS topics, TRS oral and poster presentations, research awards, and promotions in the TRS field.

Thirty-five unique trainees (49% [n = 17] female, 29% [n = 10] Black) from eight institutions within the A-TRAC network participated in the fellowship since its inception. The trainees reported 74 TRS publications, 78 TRS oral or poster presentations, 25 FDA Docket comment submissions, and 13 funded grant awards. Participant evaluations indicated six areas of programmatic strength: 1) blended instruction medium with webinars and in-person meetings, 2) curricular emphasis on theories of experiential learning, 3) focus on career and professional development, 4) integrated mentorship model, 5) culture of feedback and feedforward to foster successful learning, and 6) focus on recruiting diverse participants. The A-TRAC model stresses experiential education, feedback and feedforward, and peer learning.

Our resource-effective, needs-driven program is a reproducible model for institutions interested in developing multisite, virtual research education programs in the era of team science.

Mentorship is critical for faculty success, satisfaction, and engagement. However, many faculty, particularly underrepresented racial/ethnic (UR) faculty, lack access to high-quality mentoring. In an effort to improve mentoring for all faculty, we developed and implemented a formally structured faculty mentor training program (FMTP) across UC San Diego Health Sciences, which included institutional support, mentorship training, and department/division mentorship programs.

FMTP impact was evaluated using three primary outcome variables: mentoring quality, mentoring behaviors, and institutional climate. Participants’ self-assessed mentoring competencies were measured using validated instruments.

A total of 391 (23%) of Health Sciences faculty participated in FMTP. Participation rate was higher for women than men (30% versus 17%) and highest for UR faculty (39%). FMTP was implemented in 16 of 19 departments. Self-reported mentoring improved for FMTP participants with mentoring quality (p = 0.009) and meeting mentees’ expectations (p = 0.01) continuing to improve for up to 2 years after training. However, participants were unsure if they were meeting UR mentees’ expectations. FMTP participants were significantly more satisfied with mentoring quality (p < 0.001) compared to non-participants, with the greatest increase in satisfaction reported by UR faculty (38–61%). UR faculty reported improved overall morale (51–61%) and a perception that the environment was supportive for UR faculty (48–70%).

The implementation of a system-wide formal structured FMTP was associated with improved faculty satisfaction, quality of mentoring, and institutional climate, especially for UR faculty.

The success of any clinical research team is dependent on hiring individuals with the experience and skill set needed for a specific research project. Strategies to improve the ability of human resource (HR) recruiters to screen and advance qualified candidates for a project will result in improved initiation and execution of the project.

HR recruiters play a critical role in matching research applicants to the posted job descriptions and presenting a list of top candidates to the PI/hiring manager for interview and hiring consideration.

Creating guidelines to screen for applicant qualification based on resumes when clinical research positions have multiple levels of expertise required is a complex process of discovery, moving from subjective rationale for rating individual resumes to a more structured less biased evaluation process. To improve the hiring process of the research workforce, we successfully developed guidelines for categorizing research coordinator applications by level from beginner to advanced.

Through guideline development, we provide a framework to reduce bias and improve the matching of applicant resumes to job levels for improved selection of top candidates to advance for interviewing. Improved applicant to job matching offers an advantage to reduce hiring time, anticipate training needs, and shorten the timeline to active project engagement. These guidelines can form the basis for initial screening and ultimately matching individual qualities to project-specific needs.