The Critical Need for Academic Health Centers to Assess the Training, Support, and Career Development Requirements of Clinical Research Coordinators: Recommendations from the Clinical and Translational Science Award Research Coordinator Taskforce*

Abstract

Clinical Research Coordinators (CRCs) are a vital component of the clinical research enterprise providing a pivotal role in human subject protection through the numerous activities and responsibilities assigned to them. In 2006, the National Institutes of Health's National Center for Research resources (NCRR) implemented the Clinical and Translational Science Awards program (CTSA) to advance biomedical research. As a part of this endeavor, many workgroups were formed among the Consortium to support translational research. The Research Coordinator Taskforce was created as part of the Regulatory Knowledge group of the Clinical Research Innovation Key Function Committee, and focuses on enhancing CTSA capabilities to provide support and training for CRCs. In the spring of 2008, this taskforce conducted two surveys of the then 24 CTSA Consortium members to better understand the current expectations and responsibilities of research coordinators in addition to the mechanism for providing education, training, and support in order for CRCs to successfully meet the study responsibilities placed upon them. The results of these surveys are summarized in this article and provide context to the recommendations of the Research Coordinator Taskforce for institutional considerations, approaches, and best practices for providing education, training, and support the expanding role of CRCs in fulfi lling their responsibilities delegated to them by investigators. Clin Trans Sci 2012; Volume 5: 470-475

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

“…These principal components closely paralleled the theoretical competency domains described by Sonstein et al for the JTF as well as those described by the Enhancing Clinical Research Professionals" Training and Qualifications group. 10,12 We scanned the structure matrix (Promax rotation; Kappa=5) to identify the most important competencies defining each component that would enable us to reduce the number of items necessary to create a shorter, more easily administered survey instrument. We identified the two highest loading items on each of the nine factors and included two additional items from the Medicines Development factor that had loadings of 0.797 and 0.792 respectively yielding a total of 20 core competencies.…”

Core Competencies of Clinical Research Coordinators

“…The reasons are: 1) protocols have become progressively more complex, and regulations intended to protect the safety of research subjects and study data integrity have continued to evolve; 2) as a result, the CRC's role has become more sophisticated and the CRC's responsibilities have expanded even though training programs do not cover these new responsibilities of CRCs; and 3) the additional responsibilities of CRCs place increasing burdens that could adversely affect their primary role of research subject management [2]. However, several articles suggested that only approximately half of CRCs had opportunities of training [2][3]. A warning letter by the US FDA also suggested inadequate training of CRCs [4].…”

“…A warning letter by the US FDA also suggested inadequate training of CRCs [4]. The Clinical and Translational Science Award Research Coordinator Taskforce of the US National Institutes of Health recommended that institutions conduct a gap analysis of their training program focusing on the core competencies of CRCs [2].…”

“…The Oncology Nursing Society provides Clinical Trials Nurse Competencies [7] for nurses in the oncology field. Approximately 30-40% of CRCs have a nursing license [2], indicating that 60-70% of CRCs have a license in another field or no license. Therefore, it is necessary to describe the core competencies that apply to all CRCs regardless of licensure.…”

A systems approach to enhance clinical research and medicines development

“…Larger pools of highly trained, competent professionals are needed to increase the industry's ability to safely and effectively bring new medicines to the marketplace. The necessity for further competency based education and training has been identified all over the world [10][11][12][13][14] . Many of the challenges outlined are worsened by the inability of the biopharmaceutical industry, governments and regulatory agencies, academic researchers, and the healthcare community to work together collaboratively.…”