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

Sonstein, Stephen A / Silva, Honorio / Jones, Carolynn T / Bierer, Barbara E

2024 Volume 15, Page(s) 1291675

Abstract: Clinical research professionals play a critical role in the design, conduct, and oversight of clinical trials, and they must have the knowledge, skills, and abilities to ensure that trials are conducted ethically, safely, and in accordance with ... ...

Abstract	Clinical research professionals play a critical role in the design, conduct, and oversight of clinical trials, and they must have the knowledge, skills, and abilities to ensure that trials are conducted ethically, safely, and in accordance with regulatory requirements. As clinical research has evolved from being a necessary activity for the development and regulatory approval of new medicines to an accredited academic discipline and, more recently, to a globally recognized profession, the methods of education and training of professionals have also evolved. Initially, on-the-job informal coaching and specialized training organizations led to formalized and accredited academic degree programs and, more recently, to international competency standards and competency maintenance through continuous professional development. The Joint Task Force (JTF) for Clinical Trial Competency is a multidisciplinary, international group of experts who came together to aggregate and refine competency standards for clinical research professionals, first published in 2014. The 8 domains and 49 specific core competencies of the JTF Framework have become a globally recognized standard upon which education and training programs, role descriptions, and upward mobility criteria for professionals are now based. The JTF meets regularly and, through its workgroups, continues to evolve in response to the changing needs of the profession. The JTF is committed to continuous improvement to ensure that clinical research professionals have the competence necessary to conduct safe, ethical, and high-quality clinical research.
Language	English
Publishing date	2024-01-18
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2587355-6
ISSN	1663-9812
ISSN	1663-9812
DOI	10.3389/fphar.2024.1291675
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Article ; Online: Clinical Trial Site Perspectives and Practices on Study Participant Diversity and Inclusion.

MacLennan, Demi L / Plahovinsak, Jennifer L / MacLennan, Rob J / Jones, Carolynn T

Clinical pharmacology and therapeutics

2023 Volume 113, Issue 3, Page(s) 670–679

Abstract: Clinical trial participant populations fail to adequately represent target populations that drugs are intended to serve. Improving racial and ethnic diversity of clinical trial participants is essential for generalizable, quality clinical research ... ...

Abstract	Clinical trial participant populations fail to adequately represent target populations that drugs are intended to serve. Improving racial and ethnic diversity of clinical trial participants is essential for generalizable, quality clinical research results and ensuring social and medical equity. Site-level clinical research professionals (CRPs) have unique insights on diversity improvement strategies for clinical trial enrollment. A survey was distributed to current CRPs working at clinical research sites in the United States to describe current practices and perceptions of the impact these practices have on participant diversity. Subsequently, descriptive quantitative analysis and inductive content analysis were performed. For the practices surveyed, there are discrepancies between frequency of use and perceived impact on diversity enrollment. Common current practices include phone-based or telemedicine study visits, electronic/digital data collection, and participant compensation. However, we report travel reimbursement and services, translated documents and translator services, and adequate participant compensation as most impactful on diverse enrollment. A multistakeholder approach is necessary to enhance diversity and inclusion (D&I) of study participants. Besides large-scale solutions such as countering community distrust, actionable steps are needed by sponsors and study sites to improve D&I of trial participants. Study leadership at the sponsor, contract research organization (CRO), and site-level should create diversity plans prior to study start, and CRO and sponsor budgets should consider D&I strategies during study planning. Planning should incorporate strategies to improve D&I including adequate participant compensation, translated documents and translator services, and travel reimbursements.
MeSH term(s)	Humans ; United States ; Research Design ; Surveys and Questionnaires ; Cultural Diversity
Language	English
Publishing date	2023-01-11
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	123793-7
ISSN	1532-6535 ; 0009-9236
ISSN (online)	1532-6535
ISSN	0009-9236
DOI	10.1002/cpt.2817
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Article: Joint Task Force for Clinical Trial Competency and Clinical Research Professional Workforce Development.

Sonstein, Stephen A / Jones, Carolynn T

Frontiers in pharmacology

2018 Volume 9, Page(s) 1148

Abstract: Clinical research workforce development efforts have focused on both increasing the size of the workforce of investigators and professionals working in the clinical research enterprise, but also the education and training of those individuals to ensure ... ...

Abstract	Clinical research workforce development efforts have focused on both increasing the size of the workforce of investigators and professionals working in the clinical research enterprise, but also the education and training of those individuals to ensure the quality of study performance to improve the public's health. A major contribution to these efforts has been the establishment of core competencies for clinical research professionals by the Joint Task Force for Clinical Trial Competency. This article reviews the development of the clinical research core competencies, their wide adoption and influence on job descriptions, education, training, and academic accreditation.
Language	English
Publishing date	2018-10-16
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2587355-6
ISSN	1663-9812
ISSN	1663-9812
DOI	10.3389/fphar.2018.01148
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Article ; Online: Development and evaluation of a clinical research nursing module for undergraduate nursing schools: expanding Clinical Research Nurses' outreach.

Capili, Bernadette / Baker, Laura / Thangthaeng, Nopporn / Legor, Kristen / Larkin, Mary E / Jones, Carolynn T

Journal of research in nursing : JRN

2022 Volume 27, Issue 1-2, Page(s) 68–77

Abstract: Background: Clinical Research Nurses (CRNs) care for study participants and manage clinical research studies; yet the CRN practice role is rarely covered in undergraduate nursing curricula in the United States. Despite a burgeoning need for CRNs, the ... ...

Abstract	Background: Clinical Research Nurses (CRNs) care for study participants and manage clinical research studies; yet the CRN practice role is rarely covered in undergraduate nursing curricula in the United States. Despite a burgeoning need for CRNs, the pipeline of clinical research nurse positions remains sparse. The International Association of Clinical Research Nurses's (IACRN) strategic goal to "engage with nursing schools to heighten awareness and inclusion of the CRN role competencies in nursing education" prompted the development of an educational lecture module to be disseminated to nursing schools. This project is a pilot launch of the module. Methods: A task force of IACRN was formed to develop educational materials that could be used as outreach to undergraduate nursing schools. The content included a slide presentation covering an overview of clinical research, the CRN practice, three embedded videos showing CRN and study participant perspectives, and coverage of the care of participants of research by staff nurses. Due to COVID-19 we revised our live lecture approach using either a live synchronous webinar presentation, or an embedded asynchronous course module with YouTube videos for course learning management systems. We presented the content to 408 nursing students attending three academic programs. To evaluate effectiveness and satisfaction, an anonymous, post-presentation survey using web-based Qualtrics Results: Content and delivery of the module was positively evaluated. There was an improvement in knowledge in each topic. Evaluation responses showed that the content could likely or very likely improve care for their patients (87.4%) and improve patient education for patients in clinical trials (95%). Conclusions: Delivering a synchronous or asynchronous module about the CRN practice role to nursing students in academic nursing programs is valuable to increasing awareness of the care of patients in clinical trials, the CRN role, and future professional development.
Language	English
Publishing date	2022-04-01
Publishing country	England
Document type	Journal Article
ZDB-ID	2173772-1
ISSN	1744-988X ; 1744-9871
ISSN (online)	1744-988X
ISSN	1744-9871
DOI	10.1177/17449871211070972
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Article ; Online: Nurses in clinical trials: perceptions of impact on the research enterprise.

Jones, Carolynn T / Griffith, Catherine A / Fisher, Cheryl A / Grinke, Kathleen A / Keller, Rosemary / Lee, Hyacinth / Purdom, Michelle / Turba, Elyce

Journal of research in nursing : JRN

2022 Volume 27, Issue 1-2, Page(s) 50–65

Abstract: Background: Clinical Research Nurses practice across a wide spectrum of roles and settings within the global research enterprise. Clinical Research Nurses working with clinical trials face a dual fidelity in their role, balancing integrity of the ... ...

Abstract	Background: Clinical Research Nurses practice across a wide spectrum of roles and settings within the global research enterprise. Clinical Research Nurses working with clinical trials face a dual fidelity in their role, balancing integrity of the protocol and quality care for participants. Aims: The purpose of this study was to describe Clinical Research Nurses' experiences in clinical trials, educational preparation, and career pathways, to gain a deeper understanding of clinical research nursing contributions to the clinical research enterprise. Methods: An internet-based survey was conducted to collect demographic data and free text responses to four open-ended queries related to the experience of nurses working in clinical trials research, educational preparation, and role pathways. Qualitative content analysis was used to analyze free text responses. The study was guided by the Clinical Research Nursing Domain of Practice and Duffy's Quality Caring Model of relationship centered professional encounters. Results: Forty clinical research nurses responded to the open-ended questions with themes related to dual fidelity to study participants and protocols, relationships and nursing care, interdisciplinary team membership and contributing to science, emerging from the data. Gaps in educational preparation and professional pathways were identified. Conclusion: This study provides insights to unique clinical research nurse practice contributions in the clinical trial research enterprise within a context of Duffy's Quality Caring Model.
Language	English
Publishing date	2022-04-01
Publishing country	England
Document type	Journal Article
ZDB-ID	2173772-1
ISSN	1744-988X ; 1744-9871
ISSN (online)	1744-988X
ISSN	1744-9871
DOI	10.1177/17449871211073757
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Article ; Online: Concerning rates of laboratory-confirmed antifungal-resistant onychomycosis and tinea pedis: An online survey of podiatrists, United States.

Benedict, Kaitlin / Gold, Jeremy A W / Jones, Carolynn T / Tushla, Lisa A / Lipner, Shari R / Joseph, Warren S / Tower, Dyane E / Elewski, Boni / Pappas, Peter G

Health science reports

2023 Volume 6, Issue 11, Page(s) e1694

Language	English
Publishing date	2023-11-24
Publishing country	United States
Document type	Journal Article
ISSN	2398-8835
ISSN (online)	2398-8835
DOI	10.1002/hsr2.1694
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Article ; Online: Interventional cardiologists: Beware and be aware: An updated report of radiation-induced cutaneous cancers.

Eagan, John T / Jones, Carolynn T / Roubin, Gary S

Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions

2017 Volume 91, Issue 3, Page(s) 475–477

Abstract: We describe 5 years of follow-up of a previously reported case of disabling ionizing radiation (IR)-related cutaneous cancer in a high-volume interventional cardiologist. This case illustrates the cycle of exposure, disease, remission, and re-exposure ... ...

Abstract	We describe 5 years of follow-up of a previously reported case of disabling ionizing radiation (IR)-related cutaneous cancer in a high-volume interventional cardiologist. This case illustrates the cycle of exposure, disease, remission, and re-exposure that demonstrates the cause-and-effect relationship between radiation exposure and cutaneous cancer. Prior cautions for working in environments with radiation exposure emphasized strict adherence to the ALARA principle and called for improved radiation protection equipment. New studies stress that radiation exposure should be as near to zero as possible and place a call for research and technologies that mitigate the use of IR for all interventionists.
MeSH term(s)	Carcinoma, Basal Cell/etiology ; Carcinoma, Basal Cell/pathology ; Carcinoma, Basal Cell/therapy ; Carcinoma, Squamous Cell/etiology ; Carcinoma, Squamous Cell/pathology ; Carcinoma, Squamous Cell/therapy ; Humans ; Male ; Melanoma/etiology ; Melanoma/pathology ; Melanoma/therapy ; Middle Aged ; Neoplasms, Radiation-Induced/etiology ; Neoplasms, Radiation-Induced/pathology ; Neoplasms, Radiation-Induced/therapy ; Occupational Exposure/adverse effects ; Occupational Health ; Radiation Dosage ; Radiation Exposure/adverse effects ; Radiography, Interventional/adverse effects ; Radiologists ; Risk Factors ; Skin Neoplasms/etiology ; Skin Neoplasms/pathology ; Skin Neoplasms/therapy ; Treatment Outcome
Language	English
Publishing date	2017-10-16
Publishing country	United States
Document type	Case Reports
ZDB-ID	1459995-8
ISSN	1522-726X ; 1522-1946
ISSN (online)	1522-726X
ISSN	1522-1946
DOI	10.1002/ccd.27258
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Zs.A 1226: Show issues

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Jg. 1995 - 2021: Lesesall (1.OG)
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Article ; Online: Indices of Clinical Research Coordinators' Competence.

Hornung, Carlton A / Ianni, Phillip A / Jones, Carolynn T / Samuels, Elias M / Ellingrod, Vicki L

Journal of clinical and translational science

2019 Volume 3, Issue 2-3, Page(s) 75–81

Abstract: Introduction: There is a clear need to educate and train the clinical research workforce to conduct scientifically sound clinical research. Meeting this need requires the creation of tools to assess both an individual's preparedness to function ... ...

Abstract	Introduction: There is a clear need to educate and train the clinical research workforce to conduct scientifically sound clinical research. Meeting this need requires the creation of tools to assess both an individual's preparedness to function efficiently in the clinical research enterprise as well as tools to evaluate the quality and effectiveness of programs that are designed to educate and train clinical research professionals. Here we report the development and validation of a competency self-assessment entitled the Competency Index for Clinical Research Professionals, version II (CICRP-II). Methods: CICRP-II was developed using data collected from clinical research coordinators (CRCs) participating in the "Development, Implementation and Assessment of Novel Training In Domain-Based Competencies" project at four clinical and translational science award (CTSA) hubs and partnering institutions. Results: An exploratory factor analysis identified a two-factor structure: the first factor measures self-reported competence to perform routine clinical research functions while the second factor measures competence to perform advanced clinical functions. We demonstrate the between groups validity by comparing CRCs working in different research settings. Discussion: The excellent psychometric properties of CICRP-II, its ability to distinguish between experienced CRCs at research intensive CTSA hubs and CRCs working in less intensive community-based sites coupled with the simplicity of alternative methods for scoring respondents make it a valuable tool for gauging an individual's perceived preparedness to function in the role of CRC as well as an equally valuable tool to evaluate the value and effectiveness of clinical research education and training programs.
Language	English
Publishing date	2019-07-24
Publishing country	England
Document type	Journal Article
ISSN	2059-8661
ISSN (online)	2059-8661
DOI	10.1017/cts.2019.381
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Article ; Online: Description of Cryptococcosis Following SARS-CoV-2 Infection: A Disease Survey Through the Mycosis Study Group Education and Research Consortium (MSG-19).

Walker, Jeremey / McCarty, Todd / McGwin, Gerald / Ordaya, Eloy E / Vergidis, Paschalis / Ostrosky-Zeichner, Luis / Mammadova, Mehriban / Spec, Andrej / Rauseo, Adriana M / Perfect, John / Messina, Julia / Vilchez, Gabriel / McMullen, Rachel / Jones, Carolynn T / Pappas, Peter G

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

2023 Volume 78, Issue 2, Page(s) 371–377

Abstract: Background: Invasive fungal infections have been described throughout the COVID-19 pandemic. Cryptococcal disease after infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been reported in several isolated case reports and 1 ... ...

Abstract	Background: Invasive fungal infections have been described throughout the COVID-19 pandemic. Cryptococcal disease after infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been reported in several isolated case reports and 1 larger case series. We sought to describe cryptococcal infections following SARS-CoV-2 through establishing a database to investigate underlying risk factors, disease manifestations, and outcomes. Methods: We created a crowdsourced call for cases solicited through the Mycoses Study Group Education and Research Consortium, the Centers for Disease Control and Prevention Emerging Infectious Diseases Network, and infectious diseases Twitter groups. Data were collected in a web-based and secure REDCap survey without personal identifiers. Results: Sixty-nine cases were identified and submitted by 29 separate institutional sites. Cryptococcosis was diagnosed a median of 22 days (interquartile range, 9-42 days) after SARS-CoV-2 infection. Mortality among those with available follow-up was 72% (26/36) for the immunocompetent group and 48% (15/31) for the immunocompromised group (likelihood ratio, 4.01; P = .045). We observed a correlation between disease manifestation (central nervous system infection, proven/probable disseminated disease, and respiratory) and mortality (P = .002). Conclusions: The mortality rate of 59% for patients with cryptococcosis following SARS-CoV-2 is higher than that of modern Cryptococcus cohorts. There was an association between immunocompromised status and cryptococcal disease manifestations as well as mortality. Moreover, our series emphasizes the need for clinical and laboratory assessment of opportunistic infections beyond 30 days when concerning symptoms develop.
MeSH term(s)	Humans ; COVID-19 ; Pandemics ; SARS-CoV-2 ; Cryptococcosis/drug therapy ; Cryptococcus
Language	English
Publishing date	2023-09-15
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, P.H.S.
ZDB-ID	1099781-7
ISSN	1537-6591 ; 1058-4838
ISSN (online)	1537-6591
ISSN	1058-4838
DOI	10.1093/cid/ciad551
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Zs.A 1505: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Issues for recruitment and retention of clinical research professionals at academic medical centers: Part 1 - collaborative conversations Un-Meeting findings.

Knapke, Jacqueline M / Snyder, Denise C / Carter, Karen / Fitz-Gerald, Meredith B / Fritter, Jessica / Kolb, H Robert / Marchant, Mark / Mendell, Angela / Petty, Megan / Pullum, Cherese / Jones, Carolynn T

Journal of clinical and translational science

2022 Volume 6, Issue 1, Page(s) e80

Abstract: 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 ... ...

Abstract	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.
Language	English
Publishing date	2022-06-03
Publishing country	England
Document type	Journal Article
ISSN	2059-8661
ISSN (online)	2059-8661
DOI	10.1017/cts.2022.411
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