Indices of clinical research coordinators’ competence

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.

The appearance and increase in the quantity and proportion of the clinical research coordinator’s service fee in drug clinical trial research fund and its impact on trial quality

“…The majority of CRC practitioners are mostly undergraduate or even community college graduates in pharmacy or nursing, and their professional skills are poor. In addition, most of them enter the CRC industry immediately after graduation, with no working experience and insufficient professional knowledge accumulation [ 15 ]. In addition to the inadequate training of SMO companies, many incompetent CRCs are sent to hospitals to perform CRC functions.…”

Acute care research competencies for clinical research professionals

“…The evaluation should certainly include an evaluation of the competency of the learners operating within the framework, but that is only one piece. Several measures exist to assess CRP competency, both in general and in specialized roles such as data management and regulatory affairs [14,15]. These could be incorporated into an evaluation plan, as well as institutional metrics directly tied to clinical research activities (e.g., time from notice of grant award to study opening) [16] and CRP job satisfaction (including recruitment and retention).…”

The DIAMOND portal: An innovative platform for sharing translational research workforce training and assessment resources

“…Nearly two-thirds (26) of these assessments included measures of participant experiencesuch as engagement and satisfaction-and just over a one-third (15) include measures of specific learning outcomes. The DIAMOND team also participated in creating and testing a selfassessment aimed at measuring self-perceived self-efficacy in the competency domains called the Competency Index for Clinical Research Professionals [8,9]. This work is also available as an assessment in the DIAMOND portal.…”