Research coordinators (RCs) are vital to the clinical research enterprise, ensuring research is conducted ethically, results are scientifically sound and human research subjects are protected. Given the absence of a prior systematic inquiry, we sought to understand the ways in which Clinical & Translational Science Award-funded academic health centers support RCs.

Our survey asked questions about existing coordinator networks and where none existed, collected data on the characterization of resources and services provided to support RCs (outside of salary).

Findings show 4 mechanisms support RCs: identification of the workforce, professionalization of the position, dissemination of information, and offering of services.

An academic health center that wishes to deliver research training and services to their RC workforce will need identification and communication structures in place before supportive activities can be effectively implemented.

Training 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.

Clinical and Translational Science Awards representatives refined competency statements. Working groups developed assessments, identified training, and highlighted gaps.

Forty-eight competency statements in 8 domains were developed.

Training 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.

The 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.

In 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.

This 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.

We 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.