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.

scholarly journals 2479 Acute care research competencies for clinical research professionals: A practitioner inquiry approach and assessment

2018 ◽  
Vol 2 (S1) ◽  
pp. 51-51
Author(s):  
Jacqueline Knapke ◽  
Brett Kissela ◽  
Lynn Babcock ◽  
Schuckman Stephanie
Keyword(s):  
Clinical Research ◽  
Acute Care ◽  
Task Force ◽  
Care Research ◽  
Joint Task ◽  
Research Competencies ◽  
Joint Task Force ◽  
Trial Competency ◽  
New Hire ◽  
Research Professionals

OBJECTIVES/SPECIFIC AIMS: Acute care research is a unique area of clinical research that demands specialized skills, knowledge, and talents from empathetic professionals working in the field. Building off existing competencies for clinical research professionals, the Cincinnati Acute Care Research Council (ACRC) developed additional areas of competency for professionals working in the acute care research discipline. METHODS/STUDY POPULATION: Qualitative data obtained from job shadowing, clinical observations, and interviews were analyzed to understand the educational needs and desires of the acute care research workforce. We then utilized Bloom’s Taxonomy to build acute care research competencies that are measurable for job performance and build off of foundational clinical research professionals’ domains and competencies developed by the Joint Task Force of Clinical Trial Competency. RESULTS/ANTICIPATED RESULTS: Results suggest 35 special interest competencies for acute care clinical research professionals under 8 common domains set by the Joint Task Force of Clinical Trial Competency. Additionally an approved ACRC tactic, from actionable learnings through community assessments throughout 2017, is the creation of a Task Force made up of acute care research Principal Investigators and Clinical Research Directors to focus on the identified training and professional development obstacles in the clinical research enterprise. DISCUSSION/SIGNIFICANCE OF IMPACT: The competencies developed for acute care research should serve as guidelines for training a workforce prepared for the challenges of conducting research with each acute audience, as its own vulnerable population. These competencies will guide development of a multi-pronged program of professional development that will include new hire onboarding, new hire on-job training, and ongoing on-job training.

Leveling the Joint Task Force Core Competencies for Clinical Research Professionals

2020 ◽  
Vol 54 (1) ◽  
pp. 1-20 ◽  
Author(s):  
Stephen A. Sonstein ◽  
Rebecca J. Namenek Brouwer ◽  
William Gluck ◽  
H. Robert Kolb ◽  
Carmen Aldinger ◽  
...  
Keyword(s):  
Clinical Research ◽  
Task Force ◽  
Core Competencies ◽  
Joint Task ◽  
Joint Task Force ◽  
Research Professionals

scholarly journals 2007 The clinical research operations program: Educating clinical research staff

2018 ◽  
Vol 2 (S1) ◽  
pp. 61-61
Author(s):  
Peg Tsao ◽  
Veronica Haight ◽  
Ashley Dunn ◽  
Lisa Jackson ◽  
Steven Goodman
Keyword(s):  
Clinical Research ◽  
Task Force ◽  
Regulatory Compliance ◽  
Easy Access ◽  
Staff Retention ◽  
Final Exam ◽  
Joint Task ◽  
Class Environment ◽  
Trial Competency ◽  
Safety Considerations

OBJECTIVES/SPECIFIC AIMS: The Clinical Research Operations Program is a free educational program designed to educate clinical research personnel on the conduct of clinical research (CR). The participant completes 16 required core sessions (24 h), 4 elective sessions (4 h), and passes the final exam to receive a certification in CR operations at Stanford. Sessions focus on the 9 domains of CR (established by the Joint Task Force for Clinical Trial Competency), such as Ethical & Participant Safety Considerations, Clinical Study Operations, & Data Management/Informatics. METHODS/STUDY POPULATION: Sessions are taught by volunteer lecturers. Participants may also attend the sessions without pursuing the certification. The program objective is to provide easy-access education in CR in order to increase regulatory compliance, staff retention, and improve CR at Stanford. The program targets CR coordinators, however, staff, postdocs, fellows, and faculty also participate. RESULTS/ANTICIPATED RESULTS: Since the program’s launch in January 2017, 119 individuals have enrolled in the certification program. The most represented group is the Department of Medicine. Sessions consistently reach their maximum with a waiting list. Each core session requires that the participant complete an evaluation (Likert scale, 1–5) of the registration process (4.5/5), the class environment (4.6/5), the presented content (4.5/5), and the instructor (4.6/5). Data from these evaluations are positive to date and is used to continually refine the program. DISCUSSION/SIGNIFICANCE OF IMPACT: N/A.

scholarly journals Clinical research coordinators’ instructional preferences for competency content delivery

2018 ◽  
Vol 2 (4) ◽  
pp. 217-222
Author(s):  
H. Robert Kolb ◽  
Huan Kuang ◽  
Linda S. Behar-Horenstein
Keyword(s):  
Clinical Research ◽  
Analysis Of Variance ◽  
Repeated Measures ◽  
Task Force ◽  
Content Delivery ◽  
Educational Training ◽  
Delivery Methods ◽  
Trial Competency ◽  
Safety Considerations ◽  
Training Delivery

IntroductionA lack of standardized clinical research coordinator (CRC) training programs requires determining appropriate approaches for content delivery. The purpose of this study was to assess CRCs preferred training delivery methods related to the 8 designated Joint Task Force Clinical Trial Competency domains.MethodsRepeated measures analysis of variance and split-plot analysis of variance were adopted to compare the group means among 5 training delivery methods by 8 competency content domains and to examine whether demographic variables caused different preference patterns on the training delivery methods.ResultsParticipants reported a preference for online video; mentoring/coaching was the least preferred. Significant training delivery method preferences were reported for 3 content domains: participant safety considerations, medicines development and regulation, and clinical trials operations.DiscussionObserved statistical differences in the training delivery methods by the content domains provides guidance for program development. Ensuring that standardized educational training is aligned with the needs of adult learners may help ensure that CRCs are appropriately prepared for the workforce.

Leveling the Joint Task Force Core Competencies for Clinical Research Professionals

2018 ◽  
pp. 216847901879929 ◽  
Author(s):  
Stephen A. Sonstein ◽  
Rebecca J. Namenek Brower ◽  
William Gluck ◽  
H. Robert Kolb ◽  
Carmen Aldinger ◽  
...  
Keyword(s):  
Clinical Research ◽  
Task Force ◽  
Core Competencies ◽  
Joint Task ◽  
Joint Task Force ◽  
Research Professionals

scholarly journals Enhancing Clinical Research Professionals’ Training and Qualifications (ECRPTQ): Recommendations for Good Clinical Practice (GCP) training for investigators and study coordinators

2017 ◽  
Vol 1 (1) ◽  
pp. 8-15 ◽  
Author(s):  
Thomas P. Shanley ◽  
Nancy A. Calvin-Naylor ◽  
Ruthvick Divecha ◽  
Michelle M. Wartak ◽  
Karen Blackwell ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Clinical Research ◽  
Behavioral Interventions ◽  
Task Force ◽  
Good Clinical Practice ◽  
Translational Science ◽  
Minimum Criteria ◽  
Research Professionals

IntroductionThe translation of discoveries to drugs, devices, and behavioral interventions requires well-prepared study teams. Execution of clinical trials remains suboptimal due to varied quality in design, execution, analysis, and reporting. A critical impediment is inconsistent, or even absent, competency-based training for clinical trial personnel.MethodsIn 2014, the National Center for Advancing Translational Science (NCATS) funded the project, Enhancing Clinical Research Professionals’ Training and Qualifications (ECRPTQ), aimed at addressing this deficit. The goal was to ensure all personnel are competent to execute clinical trials. A phased structure was utilized.ResultsThis paper focuses on training recommendations in Good Clinical Practice (GCP). Leveraging input from all Clinical and Translational Science Award hubs, the following was recommended to NCATS: all investigators and study coordinators executing a clinical trial should understand GCP principles and undergo training every 3 years, with the training method meeting the minimum criteria identified by the International Conference on Harmonisation GCP.ConclusionsWe anticipate that industry sponsors will acknowledge such training, eliminating redundant training requests. We proposed metrics to be tracked that required further study. A separate task force was composed to define recommendations for metrics to be reported to NCATS.

scholarly journals 2353

2017 ◽  
Vol 1 (S1) ◽  
pp. 48-48
Author(s):  
Megan Hoffman ◽  
Jennifer Maas ◽  
Lisa Johnson
Keyword(s):  
Clinical Research ◽  
Training Program ◽  
Task Force ◽  
Baseline Assessment ◽  
University Of Minnesota ◽  
Clinical Research Coordinator ◽  
Research Coordinator ◽  
The University ◽  
Post Assessment ◽  
Research Professionals

OBJECTIVES/SPECIFIC AIMS: To increase knowledge and application of clinical research coordinator competencies among Research Professionals at the University of Minnesota. METHODS/STUDY POPULATION: The UMN’s CTSI developed and piloted a Foundations for Research Professionals training program comprised of: a baseline assessment, 7 online modules, 4 in-person training sessions, video and reading assignments and a post assessment, which totaled 30–35 hours of training and covered the following topics: preparing for a study, study management, participant recruitment and engagement, assessing capacity to consent and the informed consent process. This course also provides valuable resources and connections to online references and materials. The competencies for this program were based on work of the Joint Task Force for Clinical Trial Competency. RESULTS/ANTICIPATED RESULTS: 30 clinical research professionals completed the pilot program and averaged an increase of 6.5% from baseline assessment to post assessment. Participants were asked to rate their confidence on a variety of role-based competencies at the time of preassessments and postassessments. Trends show an increase in confidence for all competency areas after completion of the training program. DISCUSSION/SIGNIFICANCE OF IMPACT: Developing a workforce of competent research professionals is integral to improve the efficiency, quality, and ethics of research. The Foundations for Research Professionals training program increased knowledge of clinical research coordinator competencies. We will assess impact on application of the competencies 6 months after completion of the program. Our next steps include offering the training program as a 2-week session on an ongoing basis for new coordinators at the University of Minnesota.

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>

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