scholarly journals Education and training of clinical and translational study investigators and research coordinators: A competency-based approach

2017 ◽  
Vol 1 (1) ◽  
pp. 16-25 ◽  
Author(s):  
Nancy A. Calvin-Naylor ◽  
Carolynn Thomas Jones ◽  
Michelle M. Wartak ◽  
Karen Blackwell ◽  
Jonathan M. Davis ◽  
...  
Keyword(s):  
Clinical Research ◽  
New Technologies ◽  
Standardized Assessments ◽  
Translational Study ◽  
Clinical Research Coordinators ◽  
Working Groups ◽  
Competency Based ◽  
Research Workforce ◽  
And Training ◽  
Research Professionals

IntroductionTraining for the clinical research workforce does not sufficiently prepare workers for today’s scientific complexity; deficiencies may be ameliorated with training. The Enhancing Clinical Research Professionals’ Training and Qualifications developed competency standards for principal investigators and clinical research coordinators.MethodsClinical and Translational Science Awards representatives refined competency statements. Working groups developed assessments, identified training, and highlighted gaps.ResultsForty-eight competency statements in 8 domains were developed.ConclusionsTraining is primarily investigator focused with few programs for clinical research coordinators. Lack of training is felt in new technologies and data management. There are no standardized assessments of competence.

scholarly journals Indices of clinical research coordinators’ competence

2019 ◽  
Vol 3 (2-3) ◽  
pp. 75-81 ◽  
Author(s):  
Carlton A. Hornung ◽  
Phillip A. Ianni ◽  
Carolynn T. Jones ◽  
Elias M. Samuels ◽  
Vicki L. Ellingrod ◽  
...  
Keyword(s):  
Clinical Research ◽  
Good Clinical Practice ◽  
Alternative Methods ◽  
Research Education ◽  
Regulatory Affairs ◽  
Clinical Research Coordinators ◽  
Perceived Preparedness ◽  
Using Data ◽  
Research Workforce ◽  
Research Professionals

AbstractIntroduction: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 and 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” (DIAMOND) project at four clinical and translational science award (CTSA) hubs and partnering institutions.Results:An exploratory factor analysis (EFA) identified a two-factor structure: the first factor measures self-reported competence to perform Routine clinical research functions (e.g., good clinical practice regulations (GCPs)), while the second factor measures competence to perform Advanced clinical functions (e.g., global regulatory affairs). We demonstrate the between groups validity by comparing CRCs working in different research settings.Discussion:The excellent psychometric properties of CICRP-II and 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.

scholarly journals 2069

2017 ◽  
Vol 1 (S1) ◽  
pp. 43-44
Author(s):  
Carlton Hornung ◽  
Carolyn Thomas Jones ◽  
Terri Hinkley ◽  
Vicki Ellingrod ◽  
Nancy Calvin-Naylor
Keyword(s):  
Clinical Research ◽  
Data Management ◽  
Core Competencies ◽  
Safety Data ◽  
The United States ◽  
Education And Training ◽  
Development Ethics ◽  
The Impact ◽  
And Training ◽  
Research Professionals

OBJECTIVES/SPECIFIC AIMS: Clinical research in the 21st century will require a well-trained workforce to insure that research protocols yield valid and reliable results. Several organizations have developed lists of core competencies for clinical trial coordinators, administrators, monitors, data management/informaticians, regulatory affairs personnel, and others. While the Clinical Research Appraisal Inventory assesses the self-confidence of physician scientists to be clinical investigators, no such index exists to assess the competence of clinical research professionals who coordinate, monitor, and administer clinical trials. We developed the Competency Index for Clinical Research Professionals (CICRP) as a general index of competency (ie, GCPs) as well as sub-scales to assess competency in the specific domains of Medicines Development; Ethics and Participant Safety; Data Management; and Research Methods. METHODS/STUDY POPULATION: We analyzed data collected by the Joint Task Force on the Harmonization of Core Competencies from a survey of research professionals working in the United States and Canada. Respondents reported how competent they believed themselves to be on 51 clinical research core competencies. Factor analyzes identified 20 core competencies that defined a Competency Index for Clinical Research Professionals—General (CICRP-General, ie, GCPs) and 4 subindices that define specialized research functions: Medicines Development; Ethics and Participant Safety; Data Management; and Research Concepts. RESULTS/ANTICIPATED RESULTS: Factor analysis identified 20 core competencies that defined a Competency Index for Clinical Research Professionals—General (CICRP-General, ie, GCPs) and 4 subindices that define specialized research functions: Medicines Development; Ethics and Participant Safety; Data Management; and Research Concepts. DISCUSSION/SIGNIFICANCE OF IMPACT: These indices can be used to gage an individual’s readiness to perform general as well as more advanced research functions; to assess the education and training needs of research workers; and to evaluate the impact of education and training programs on the competency of research coordinators, monitors, and other clinical research team members.

scholarly journals Impact of implementing a competency-based job framework for clinical research professionals on employee turnover

2020 ◽  
Vol 4 (4) ◽  
pp. 331-335
Author(s):  
Marissa Stroo ◽  
Kirubel Asfaw ◽  
Christine Deeter ◽  
Stephanie A. Freel ◽  
Rebecca J. N. Brouwer ◽  
...  
Keyword(s):  
Clinical Research ◽  
Employee Turnover ◽  
Large Scale ◽  
Turnover Rate ◽  
Medical Center ◽  
Academic Medical Center ◽  
Medical Setting ◽  
Academic Medical ◽  
Competency Based ◽  
Research Professionals

AbstractIntroduction:A new competency-based job framework was implemented for clinical research professionals at a large, clinical research-intensive academic medical center. This study evaluates the rates of turnover before and after implementation of the new framework. Turnover in this workforce (as with most) is costly; it contributes to wasted dollars and lost productivity since these are highly specialized positions requiring extensive training, regardless of experience in the field.Methods:Trends in employee turnover for 3 years prior to and after the implementation of competency-based job framework for clinical research positions were studied using human resources data. Employee demographics, turnover rates, and comparisons to national statistics are summarized.Results:Employee turnover within the clinical research professional jobs has decreased from 23% to 16%, a 45% reduction, since the implementation of competency-based job framework.Conclusion:The new jobs and career ladders, both of which are centered on a competency-based framework, have decreased the overall turnover rate in this employee population. Since little is known about the rates of turnover in clinical research, especially in the academic medical setting, the results of this analysis can provide important insights to other academic medical centers on both employee turnover rate in general and the potential impact of implementing large-scale competency-based job changes.

scholarly journals 3194 Workforce Engagement and Resilience (WE-R): A Framework for Innovating Clinical Research Careers

2019 ◽  
Vol 3 (s1) ◽  
pp. 77-78
Author(s):  
Stephanie A. Freel ◽  
Christine Deeter ◽  
Deborah Hannah ◽  
Marissa Stroo ◽  
Rebecca Brouwer ◽  
...  
Keyword(s):  
Change Management ◽  
Clinical Research ◽  
Career Planning ◽  
Strategic Communication ◽  
Assessment Process ◽  
Process Data ◽  
High Quality Research ◽  
Competency Based ◽  
Research Nurses ◽  
Research Workforce

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

scholarly journals Competency indices to assess the knowledge, skills and abilities of clinical research professionals

2018 ◽  
Vol 5 (1) ◽  
pp. 46 ◽  
Author(s):  
Carlton A. Hornung ◽  
Carolynn Thomas Jones ◽  
Nancy A. Calvin-Naylor ◽  
Jared Kerr ◽  
Stephen A. Sonstein ◽  
...  
Keyword(s):  
Clinical Research ◽  
Data Management ◽  
Task Force ◽  
Core Competencies ◽  
Safety Data ◽  
Education And Training ◽  
Regulatory Affairs ◽  
The Impact ◽  
And Training ◽  
Research Professionals

<p class="abstract"><strong>Background:</strong> Clinical research in the 21<sup>st</sup> century will require a well-trained workforce to ensure that research protocols yield valid and reliable results. Several organizations have developed lists of core competencies for clinical trial coordinators, administrators, monitors, data management/informaticians, regulatory affairs personnel and others.</p><p class="abstract"><strong>Methods:</strong> We used data collected by the joint task force on the harmonization of core competencies from a survey of research professionals working in the US and Canada to create competency Indices for clinical research professionals. Respondents reported how competent they believed themselves to be on 51 clinical research core competencies.</p><p class="abstract"><strong>Results:</strong> Factor analyzes identified 20 core competencies that defined a competency index for clinical research professionals—general (CICRP-General, i.e., GCPs) and four sub-indices that define specialized research functions: Medicines Development; Ethics and Participant Safety; Data Management; and Research Concepts.  </p><p><strong>Conclusions:</strong> These indices can be used to gage an individual’s readiness to perform general as well as more advanced research functions; to assess the education and training needs of research workers; and to evaluate the impact of education and training programs on the competency of research coordinators, monitors and other clinical research team members.</p>

Giải pháp hợp tác giữa trường đại học điện lực và doanh nghiệp trong việc đào tạo kỹ năng nghề cho sinh viên

2018 ◽  
Vol 34 (1) ◽  
Author(s):  
Nguyen Thi Thanh Dan
Keyword(s):  
Triple Helix ◽  
Vocational Skills ◽  
Government Relations ◽  
World Economic ◽  
Competency Based ◽  
Social Partnerships ◽  
Market Needs ◽  
Global Agenda ◽  
University Industry ◽  
And Training

  The purpose of the paper is to research some solutions of cooperation between universities and enterprises in training vocational skills for students. Through the survey on assessment of vocational skills of students and the need for cooperation between Enterprises and Electric Power University, the research proposes some solutions  between two elements of the mechanism of cooperation between University  and Enterprises in training vocational skills for students to ensure graduates can meet the requirements of recruitment agencies as well as the requirements of socio-economic development and employment. Keywords Volcational skill, cooperation, universities, enterprises, Electric Power University References [1] Mạnh Xuân, Gắn kết trường đại học và doanh nghiệp trong đào tạo nhân lực, Nhân dân điện tử, 2015. http://www.nhandan.com.vn/giaoduc/tin-tuc/item/25807602-gan-ket-truong-dai-hoc-va-doanh-nghiep-trong-dao-tao-nhan-luc.html [2] Nguyễn Đình Luận, Sự gắn kết giữa nhà trường và doanh nghiệp trong đào tạo nguồn nhân lực phục vụ phát triển kinh tế xã hội ở Việt Nam: Thực trạng và Khuyến nghị, Tạp chí Phát triển và hội nhập, số 22 (32), Tháng 5-6/2015.[3] Nguyễn Thị Thanh Dần, Động lực hợp tác giữa nhà trường và doanh nghiệp trong việc nâng cao kỹ năng nghề cho sinh viên, Tạp chí giáo dục, Số đặc biệt 11/2016[4] Nguyễn Tiến Long, Phạm Hồng Hạnh. Xây dựng kho dữ liệu kĩ thuật, ứng dụng cho nghiên cứu khoa học và dạy học tại trường sư phạm kỹ thuật – đạo tạo nghề. Tạp chí khoa học giáo dục, số 338 kì 2 (7/2014) [5] Trịnh Thị Hoa Mai, Liên kết đào tạo giữa trường Đại học với doanh nghiệp ở Việt Nam, Tạp chí Khoa học Đại học Quốc gia Hà Nội, Kinh tế - Luật 24 (2008), 30-34[6] Vũ Thị Phương Anh, Liên kết đào tạo giữa nhà trường và doanh nghiệp thiếu mắt xích quan trọng, Báo Nhân dân cuối tuần, 2013. http://www.nhandan.com.vn/cuoituan/chuyen-de/item/21342502-thieu-mat-xich-quan-trong.html[7] Competency-based training, TAFE Queensland, 03 December, 2008, http://www.tafe.qld.gov.au/courses/flexible study/ competencv.html. [8] Croissant, J.L., Smith-Doerr, L. (2008). Organizational Contexts of Science: Boundaries and Relationships between University and Industry. In: Hackett, Edward J.; Amsterdamska, O., Lynch, M., Wajcman, J. (eds.): The Handbook of Science and Technology Studies, 3rd edition. Cambridge u.a.: The MIT Press, pp. 691-718 [9] Dalley, Stephanie and Peter Oleson (2003).“Senacherib, Archimedes, and the Water Screw: The Context of Invention in the Ancient World”, Technology and Culture vol. 44 no. 1, pp. 1–26. 
[10] Davos Kloster (2014), Matching skills and labour market needs – Building social partnerships for better skills and better jobs, Global Agenda Council on Employment, World Economic Forum.[11] Davos Kloster (2014), Matching skills and labour market needs – Building social partnerships for better skills and better jobs, Global Agenda Council on Employment, World Economic Forum.[12] Dzisah, J. & Etzkowitz, H., (2008): Triple Helix Circulation: The Heart of Innovation and Development, International Journal of Technology Management and Sustainable Development, 7(2), pp. 101-115 [13] Etzkowitz, H., Leydesdorff, L. (2000): The Dynamics of Innovation: From National Systems and “Mode 2” to a Triple Helix of University-Industry-Government Relations. In: Research Policy, 29, pag. 109-123 [14] Harris, R., Guthrie, H., Hobart B., & Lundberg, D. (1995). Competency based education and training: Between a Rock and a Whirlpool. South Melbourne: Macmillan Education Australia.[15] Henry Etzkowitz (2008). The triple helix: university-industry-government innovation. Routledge
270 Madison Ave, New York, NY 10016, ISBN 0-203-92960-8 Master e-book ISBN [16] Jones, L., & Moore, R. (1995). Appropriating competence. British Journal of Education and Work, 8(2) 78-92[17] Kathleen Santopietro Weddel (2006), Competency Based Education and Content Standards, Northern Colorado Literacy Resource Center, USA.[18] Leydesdorff, L., Etzkowitz, H. (1996): Emergence of a Triple Helix of University-Industry-Government Relations, Science and Public Policy, 23, pp.279-286. [19] Mihaela & Cornelia Dan (2013). Why Should University and Business Cooperate? A Discussion of Advantages and Disadvantages, International Journal of Economic Practices and Theories, Vol. 3, No. 1, 2013 (January), e-ISSN 2247–7225 [20] Paprock, K. E. (1996) Conceptual structure to develop adaptive competencies in professional. IPN Ciencia Are: Cultura, Nueva Epoca, 2 (8), 22-25.[21] Perkmann, M. (2007): University-industry relationships and open innovation: towards a research agenda. International Journal of Management Reviews, 9 (4), pp. 259–280 [22] Robert E. Norton: Dacum Handbook. Center on Education and training for Employment – College of Education – The Ohio State University, 1997.[23] Shirley Fletcher (1995). Designing Competence-based Assessment in the Professions in Australia, Assessment in Education: Principles, Policy & practice, Volume1, Issue 1.[24] Urayaa, E. (2010). Conceptualizing the Regional Roles of Universities, Implications and Contradictions, European Planning Studies, 18(8), pp. 1227-1246

Tradition and Innovation in Cataloguing Medieval Manuscripts

2021 ◽  
Vol 139 (1) ◽  
pp. 32-58
Author(s):  
Orietta Da Rold
Keyword(s):  
New Technologies ◽  
New Technology ◽  
Early Career ◽  
Digital Environment ◽  
Digital Form ◽  
Postgraduate Students ◽  
Medieval Manuscripts ◽  
Early Career Researchers ◽  
History Of ◽  
And Training

Abstract In this essay, I offer a brief history of manuscript cataloguing and some observations on the innovations this practice introduced especially in the digital form. This history reveals that as the cataloguing of medieval manuscripts developed over time, so did the research needs it served. What was often considered traditional cataloguing practices had to be mediated to accommodate new scholarly advance, posing interesting questions, for example, on what new technologies can bring to this discussion. In the digital age, in particular, how do digital catalogues interact with their analogue counterparts? What skills and training are required of scholars interacting with this new technology? To this end, I will consider the importance of the digital environment to enable a more flexible approach to cataloguing. I will also discuss new insights into digital projects, especially the experience accrued by the The Production and Use of English Manuscripts 1060 to 1220 Project, and then propose that in the future cataloguing should be adaptable and shareable, and make full use of the different approaches to manuscripts generated by collaboration between scholars and librarians or the work of postgraduate students and early career researchers.

Shared-Task Worklists Improve Clinical Trial Recruitment Workflow in an Academic Emergency Department

2021 ◽  
Vol 12 (02) ◽  
pp. 293-300
Author(s):  
Kevin S. Naceanceno ◽  
Stacey L. House ◽  
Phillip V. Asaro
Keyword(s):  
Clinical Trial ◽  
Emergency Department ◽  
Clinical Trials ◽  
Clinical Research ◽  
Substantial Reduction ◽  
Text Message ◽  
High Volume ◽  
Text Messages ◽  
Shared Task ◽  
Clinical Research Coordinators

Abstract Background Clinical trials performed in our emergency department at Barnes-Jewish Hospital utilize a centralized infrastructure for alerting, screening, and enrollment with rule-based alerts sent to clinical research coordinators. Previously, all alerts were delivered as text messages via dedicated cellular phones. As the number of ongoing clinical trials increased, the volume of alerts grew to an unmanageable level. Therefore, we have changed our primary notification delivery method to study-specific, shared-task worklists integrated with our pre-existing web-based screening documentation system. Objective To evaluate the effects on screening and recruitment workflow of replacing text-message delivery of clinical trial alerts with study-specific shared-task worklists in a high-volume academic emergency department supporting multiple concurrent clinical trials. Methods We analyzed retrospective data on alerting, screening, and enrollment for 10 active clinical trials pre- and postimplementation of shared-task worklists. Results Notifications signaling the presence of potentially eligible subjects for clinical trials were more likely to result in a screen (p < 0.001) with the implementation of shared-task worklists compared with notifications delivered as text messages for 8/10 clinical trials. The change in workflow did not alter the likelihood of a notification resulting in an enrollment (p = 0.473). The Director of Research reported a substantial reduction in the amount of time spent redirecting clinical research coordinator screening activities. Conclusion Shared-task worklists, with the functionalities we have described, offer a viable alternative to delivery of clinical trial alerts via text message directly to clinical research coordinators recruiting for multiple concurrent clinical trials in a high-volume academic emergency department.

scholarly journals Acute care research competencies for clinical research professionals

2020 ◽  
Vol 4 (6) ◽  
pp. 485-492
Author(s):  
Stephanie Schuckman ◽  
Lynn Babcock ◽  
Cristina Spinner ◽  
Opeolu Adeoye ◽  
Dina Gomaa ◽  
...  
Keyword(s):  
Clinical Research ◽  
Acute Care ◽  
Performance Metrics ◽  
Task Force ◽  
Continuing Professional Development ◽  
Personal Characteristics ◽  
Care Research ◽  
Trial Competency ◽  
Conducting Research ◽  
Research Professionals

AbstractIntroduction:Acute care research (ACR) is uniquely challenged by the constraints of recruiting participants and conducting research procedures within minutes to hours of an unscheduled critical illness or injury. Existing competencies for clinical research professionals (CRPs) are gaining traction but may have gaps for the acute environment. We sought to expand existing CRP competencies to include the specialized skills needed for ACR settings.Methods:Qualitative data collected from job shadowing, clinical observations, and interviews were analyzed to assess the educational needs of the acute care clinical research workforce. We identified competencies necessary to succeed as an ACR-CRP, and then applied Bloom’s Taxonomy to develop characteristics into learning outcomes that frame both knowledge to be acquired and job performance metrics.Results:There were 28 special interest competencies for ACR-CRPs identified within the eight domains set by the Joint Task Force (JTF) of Clinical Trial Competency. While the eight domains were not prioritized by the JTF, in ACR an emphasis on Communication and Teamwork, Clinical Trials Operations, and Data Management and Informatics was observed. Within each domain, distinct proficiencies and unique personal characteristics essential for success were identified. The competencies suggest that a combination of competency-based training, behavioral-based hiring practices, and continuing professional development will be essential to ACR success.Conclusion:The competencies developed for ACR can serve as a training guide for CRPs to be prepared for the challenges of conducting research within this vulnerable population. Hiring, training, and supporting the development of this workforce are foundational to clinical research in this challenging setting.

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