Navigating the challenges of clinical trial professionals in the healthcare sector.

Clinical trials (CTs) are essential for medical advancements but face significant challenges, particularly in professional training and role clarity. Principal investigators, clinical research coordinators (CRCs), nurses, clinical trial pharmacists, and monitors are key players. Each faces unique challenges, such as maintaining protocol compliance, managing investigational products, and ensuring data integrity. Clinical trials' complexity and evolving nature demand specialized and ongoing training for these professionals. Addressing these challenges requires clear role delineation, continuous professional development, and supportive workplace environments to improve retention and trial outcomes. Enhanced training programs and a collaborative approach are essential for the successful conduct of clinical trials and the advancement of medical research.

[Evaluation of Pharmacy Students' Understanding of Clinical Trials and Research through Questionnaires Before and After the Hospital Practical Training].

A questionnaire survey was conducted to evaluate practical training and improve education on clinical trial and research. This survey was based on the results of questionnaire before and after the practical training undertaken by 240 pharmaceutical students (Kanto region; 1 university, Tokai region; 2 university, Kinki region; 9 university) at Mie University Hospital between 2011 and 2022. In the questionnaire before practical training, lectures in university (n=219, 91%) were the main source of information on clinical trials and research. Fifty-two students (22%) correctly answered the contents of phase 1-4 trials. As an occupation that can perform clinical research coordinator (CRC)'s work, only 7 students (3%) answered that "all medical and non-medical professionals" can perform the CRC's duties. Regarding the understanding of terms related to clinical trials and research, more than 90% of the students understood the meaning of "subjects," "informed consent," and "placebo" even before practical training. Otherwise, even after practical training, students' understanding of "reimbursement," "follow-up period," "audit," or "direct access" was less than 80%. Practical training improved the understanding of terms such as clinical trial (Wilcoxon signed-rank test, p<0.001), clinical research phase 1-4 trials (Wilcoxon signed-rank test, p<0.001), interest in clinical trials and research (McNemar-Bowker test, p<0.001), and understanding of CRC's work (McNemar-Bowker test, p<0.001). We will improve the content of practical training and bequeath the knowledge and importance of drug discovery and development to the next generation.

What PIs want when hiring a clinical research coordinator.

Introduction: Clinical research coordinators (CRCs) play a key role in supporting the translational research enterprise, with responsibilities encompassing tasks related to the design, implementation, and evaluation of clinical research trials. While the literature explores CRC competencies, job satisfaction, and retention, little attention has been given to the role of the PI working with Human Resources (HR) in the CRC hiring and onboarding processes. We investigated the priorities, decision-making processes, and satisfaction levels of principal investigators (PIs) and hiring managers in CRC hiring. Methods: An online survey consisting of open-ended and fixed-choice questions to gather information on desired CRC qualifications and competencies, factors influencing hiring decisions, and overall satisfaction with selected candidates was administered. The survey utilized a Task/Competency Checklist developed from job descriptions and the literature. Respondents were asked to rank the importance of factors such as CRC skill set, years of experience, educational background, and budget constraints. Results: Results indicated that the skill set of the applicant was the most frequently cited factor influencing the hiring decision, followed by years of experience. Education and budget constraints were of lesser importance. Most respondents reported a satisfaction rating of 50% or greater with their new hires, although some participants expressed challenges related to institutional training requirements, the performance of entry-level CRCs, and the qualifications of experienced candidates. Conclusion: The hiring cycle involves HR-PI collaboration for a clear job description, effective onboarding processes, and accessible professional development opportunities to enhance PI and employee satisfaction and CRC retention.

Digital badges in academia: An educational tool for the clinical research coordinator.

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

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

Introduction: 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). Methods: 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. Results: 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. Conclusions: 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.

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.

Vocational training for pediatric clinical research coordinators: current status and demand analysis / 中华医学教育探索杂志

Objective:To investigate the current status of vocational training for pediatric clinical research coordinators (CRC), and discuss the construction of base-based pediatric CRC training, and to promote the ability of pediatric CRCs.Methods:From July 25 to October 16, 2023, an anonymous self-designed questionnaire survey was conducted through the Wenjuanxing platform to investigate the current situation of pediatric CRC vocational training and base training needs. The data were collated using Excel. Categorical data were described as numbers and percentages.Results:A total of 328 usable questionnaires were returned. Only 7.62% (25 people) believed that existing CRC training was sufficient and could meet actual work needs; 4.88% (16 people) responded that there was no training; 46.34% (152 people) believed that the training was insufficient to support actual work needs; 87.50% (287 people) believed that continuous CRC training was needed; 46.95% (154 people) preferred experienced CRCs for teaching, who should have at least 3 years of CRC work experience; and 46.95% (154 people) preferred a duration of 3 months for CRC training. The preferred training methods were: practice under the direction of experienced CRCs (90.85%, 298 people), step-by-step teaching of practical skills (88.41%, 290 people), case analysis and discussion (87.20%, 286 people), process simulation (83.23%, 273 people), and lecture-based teaching (76.52%, 251 people). The preferred post-training assessment methods were: case analysis (76.52%, 251 people), operation simulation (74.09%, 243 people), process simulation (73.17%, 240 people), written examination (66.16%, 217 people), and interview (63.72%, 209 people).Conclusions:The current pediatric CRC training is not enough to meet actual work needs. It is urgent to develop and promote a CRC training system that can meet work needs, laying the foundation for the construction of pediatric clinical research ecology in China.

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.

Ascertainment of malformations in pregnancy registries: Lessons learned in the North American AED Pregnancy Registry.

BACKGROUND: Pregnancy registries, designed to assess the safety of medications and vaccines for the exposed mother and fetus, have been developed since the 1990s. Malformations present in the exposed liveborn or stillborn infant or fetuses in elective terminations are the outcome of greatest concern. The experiences of the North American AED (antiepileptic drug) Pregnancy Registry (NAAPR) can be used to identify the challenges and limitations of a pregnancy registry in identifying congenital malformations. METHODS: The NAAPR enrolls pregnant women who are taking one or more AEDs for any medical condition, but primarily to prevent seizures, and an unexposed comparison group. Participants are interviewed by clinical research coordinators (CRCs) at enrollment, later in pregnancy and postpartum. Malformations are identified in the mother's reports and her infant's medical records through age 12 weeks. A teratologist, blinded to exposure status, evaluates each potential malformation identified. RESULTS: Among 10,982 pregnancies enrolled between 1997 and 2022, 282 malformations were identified in the 9677 AED-exposed and 15 among the 1305 unexposed infants. Isolated malformations, such as cleft palate, accounted for 84% of the malformations identified. Increased frequencies of oral clefts and myelomeningocele were associated with exposure to several different AEDs. Copies of reports from many diagnostic studies were not obtained and very few pregnancy losses had autopsies. CONCLUSIONS: The evaluation of the AED-exposed infants in a pregnancy registry is indirect. Improvements rely on the rapport established with the mothers by the CRCs and the mothers' willingness to assist in obtaining information from her infants' physicians.

Clinical research coordinators' role in knowledge translation activities in rehabilitation: a mixed methods study.

BACKGROUND: Clinical research coordinators (CRCs) facilitate the interaction between researchers and knowledge users in rehabilitation centres to promote and sustain evidence-informed practices. Despite their presence in rehabilitation settings in Quebec for over 20 years, little is known about their profiles and knowledge translation (KT) activities nor how they can best enact their role. This study explored CRCs' roles and perspectives on the barriers, enablers, and strategies for improving KT activities in rehabilitation settings. METHODS: We conducted a multi-centre, participatory sequential mixed methods study. In the descriptive quantitative phase, we collected data via an online survey to determine CRCs' role in research and KT. In the subsequent qualitative phase, we conducted an in-person focus group to elicit CRCs' perspectives regarding factors influencing their work in KT, and potential solutions for overcoming these challenges. We used a descriptive and an inductive content analysis approach for the data analysis. The data synthesis was inspired by the Promoting Action on Research Implementation in Health Services framework. RESULTS: All nine CRCs from five partner health regions of a large rehabilitation research centre agreed to participate in the study. The data suggest that CRCs are like knowledge brokers and boundary spanners. As information managers, linkage agents and facilitators, CRCs play a pivot role in diffusion, dissemination, synthesis and tailoring of knowledge to improve evidence informed practices and quality of care in rehabilitation. The factors influencing CRCs' KT activities are mostly linked to the context such as the receptivity of the organization as well as the lack of time and resources, and limited understanding of their roles by stakeholders. Two main suggestions made to enhance CRCs' contribution to KT activities include the harmonisation of expectations between the large research centre and their partner health regions, and better promotion of their role to clinical and research teams. CONCLUSIONS: This study provides valuable insights into the scope of CRCs' role. The results shed light on the challenges that they face and potential solutions to overcome them. The knowledge generated in this study can be used to implement this role with similar duties in rehabilitation settings or other health care domains.

Measurement tools and rationality evaluation of clinical research coordinator's work ability and workload / 中国临床药理学与治疗学

AIM：To establish a project management tool to measure the working ability of research coordinators and the workload of clinical trial projects, and optimize medical institutions or clinical trial site management organization (SMO) allocation basis of clinical trial items by collecting the work stress and personal ability values of clinical coordinators. METHODS: Different words in the five major databases were searched and information on the work capacity and workload in the Subei People' s Hospital was collected. In addition, the paper analyzes the characteristics of coordinators working pressure source by SPSS26.0 statistical software and stability coefficient method. RESULTS: The study established the clinical research coordinator's personal ability - assessment tool (CRCPA-AT) and clinical trial project workload - assessment tool (CTPW-AT) to assess the coordinator's working ability and clinical trial workload. The two tools in this study were tested retrospectively in 61 coordinators and 144 clinical trials, 39 (66.1%) coordinators' projects were reasonably allocated, 18 (30.5%) coordinators were in the state of theoretical pressure and 12 (20.3%) coordinators had high actual pressure, which matched with the theoretical pressure. CONCLUSION: In this study, two scoring scales were established to quantify the working ability of the coordinators and the workload of clinical trial projects. Through the verification of the 61 coordinators and its management projects, the Likert5 point scoring method was used to analyze, more than 86.4% of the actual pressure of coordinators was consistent with the theoretical pressure quantified by the tool.

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.

Finding the right candidate: Developing hiring guidelines for screening applicants for clinical research coordinator positions.

Impact: 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. Objective/Goals: 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. Methods/Study Population: 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. Results/Anticipated Results: 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.

Presence and activities of clinical research coordinators at Italian Health Care Institutions: A national cross-sectional survey.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Status quo and countermeasures of job mobility among clinical research coordinator/clinical research associate in Chongqing / 中国药房

OBJECTIVE To investigate the job mo bility of cl inical research coordinators （CRCs） and clinical research associates（CRAs）in Chongqing ，and to explore the feasible methods to improve the job stability of CRCs and CRAs. METHODS Questionnaire survey was conducted to investigate the job mobility of 200 CRCs and CRAs working in 22 drug clinical trial institutions of Chongqing. The contents included basic information ，job mobility ，and reasons for mobility. RESULTS & CONCLUSIONS Totally 178 valid questionnaires were recovered ，with an efficient recovery rate of 89.00％，of which 110 were recovered from CRCs and 68 were recovered from CRAs. Among the surveyed CRCs and CRAs ，the age distribution was mainly 20-30 years old ，accounting for 87.27％ and 82.35％ of the respective population respectively. The overall educational degree of CRAs were slightly higher than those of CRCs. The majors and previous work experience were mainly related to medicine ；the proportion of other non-medicine-related professions who switched to CRCs was higher than that of CRAs. Totally 88.18％ had CRC working experience within 3 years；after having 1-＜3 years of work experience ，50.00％ had worked in 2 or more work units. Totally 64.70％ had CRA working experience within 3 years；after having 1-＜3 years of work experience ，70.37％ had worked in 2 or more work units. CRCs handled 5.38 items of clinical trials and completed 1.22 items on average ；CRAs handled 7.47 items and completes 2.04 items on average. Main reasons of CRCs and CRAs for job-hopping included low salary below expectations，few promotion opportunities ，and too much workload ，accounting for 83.64％/80.88％，45.45％/39.71％，31.82％/ 26.47％，respectively. As an important part of clinical trials ，CRCs and CRAs had high job mobility. It is suggested to establish a unified industry standard ，standardize the management rights and responsibilities of CRCs and CRAs ，optimize the working mode of CRCs and CRAs ，and improve professional identity and sense of belonging ，so as to improve the job stability of relevant

Discussion of data problems and improvement measures in clinical trials: Based on CRC work assessment in a grade A tertiary hospital / 中华医学科研管理杂志

Objective:The Clinical Research Coordinator (CRC) is responsible for transcribing and verifying clinical trial data, and making recommendations to research institutions and sponsors on clinical trial data through analyzing and discussing data problems found in CRC work assessment, thereby improving the quality of clinical trials.Methods:Based on the ALOCA+ Principle, this study analyzed the data problems found in CRC assessment based on clinical trial quality conducted in a grade A tertiary hospital in Beijing from November 2018 to December 2021, and discussed improvement measures for clinical trial data problems.Results:Among the clinical trial data problems, data integrity is the most prominent, followed by accuracy.Conclusions:Research institutions and sponsors should improve the data management system and SOP, strengthen the training for clinical trial participants, optimize a trial plan and process design, strengthen supervision and inspection, and establish a risk-based quality control system, etc., so as to make clinical trial data conform to the international ALOCA+ principle and make clinical trial results accurate and reliable.

Construction and practice of CRC management system based on the whole process of clinical trial projects / 中华医学科研管理杂志

Objective:To introduce the construction and practice of the Clinical Research Coordinator(CRC) management system based on the whole process of the clinical trial project in Ninth People′s Hospital of Shanghai Jiao Tong University School of Medicine.Methods:Constructed CRC management system with hospital features, including the management of admission, examination, training, emergency, and evaluation.Results:CRC management system was put into practice, and investigators, sponsors, and drug clinical trial institutions were highly satisfied with clinical trials using this system.Conclusions:With the gradual formation of CRC industry norms and consensus, the standardized management of CRC can promote the development of China′s pharmaceutical industry.

Strengthening the clinical research workforce through a competency-based orientation program: Process outcomes and lessons learned across three academic health institutions.

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

Factors Associated With the Acceleration of Patient Enrollment in Clinical Studies: A Cross-Sectional Study.

Under-recruitment in clinical trials is an issue worldwide. If the number of patients enrolled is lower than expected, based on the required sample size, then the reliability of the study results and their validation tend to be impaired. The current study therefore evaluated factors associated with accelerating patient enrollment using data from an ongoing multicenter prospective cohort study. The researchers encouraged research institutions to accelerate patient enrollment via e-mail, newsletters, telephone calls, and site visits. We analyzed the relationship between several potential factors associated with acceleration of patient enrollment including site visits and patient enrollment in a real clinical study. Data were collected from 106 research institutions that participated in a multicenter prospective cohort study. Results showed that the following parameters differed in terms of patient enrollment and non-enrollment: urban area (47.2 vs. 67.6%, p = 0.04), clinical research coordinator (CRC) participation in data input to electronic data capture (EDC) (41.7 vs. 11.8%, p < 0.01), and site visit (38.9 vs. 11.8%, p < 0.01). A multivariate analysis revealed that patient enrollment was significantly associated with urban area (odds ratio [OR] 0.33, 95% confidence interval [CI] 0.12-0.86, p = 0.02), CRC participation in data input to EDC (OR 5.02; 95% CI 1.49-16.8; p < 0.01), and site visit (OR 4.54, 95% CI 1.31-15.7, p = 0.01). In conclusion, site visits and CRC participation in data input to EDC had a significant effect on patient enrollment promotion. Moreover, hospitals in rural areas were more effective in promoting patient enrollment than those in urban areas.

Virtual coordinator and site training and reorganization of a multisite consortium upon grant renewal: Challenges of the NeuroNEXT network.

The COVID-19 pandemic abruptly forced changes in how to conduct multicenter clinical research. Gone were the days of face-to-face meetings and working together in person. Virtual teams became the norm rather than exception. The Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT: NN) was created with a vision to conduct studies in neurological diseases through partnership with academia, private foundations and industry. 1 A fundamental aspect of the establishment and maintenance of this network was and is the NeuroNEXT virtual coordinator network. We found ourselves well-prepared for methods required of the pandemic because of our prior experience.