Clinical Research / Clinical Trial (CRC/CRA)
Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous.
What is a Clinical Research Coordinator (CRC)
Randomized controlled trials are the gold standard practice for determining the safety and efficacy of a treatment. At the heart of these trials sits each clinical research site, the successes of which are heavily dependent on its clinical research coordinators (CRC).
Although principal investigators (PIs) are ultimately responsible for all activities conducted at a research site, most will often delegate many essential trial tasks to their CRC. The role of the CRC is primarily divided into three sets of responsibilities: performing patient visits, completing administrative tasks, and managing communications.
Depending on the number of ongoing trials at their site, a CRC may typically see multiple patients daily. These patient visits require extensive administrative follow-up afterwards to ensure all data has been adequately documented. They must also effectively address various communications from trial participants, sponsor representatives, ethics board representatives, and trial vendors.
What is a Clinical Research Associate (CRA)
Clinical trials ultimately serve to provide valuable evidence-based research on emerging medical interventions. Clinical research associates (CRAs) play a vital role in the trial sponsor’s ability to conduct proper quality control of the data collected from each clinical research site.
CRAs are responsible for providing their assigned sites with oversight and guidance, monitoring patient safety, reviewing source data, and generally acting as a liaison on behalf of the sponsor. CRAs can be involved in any phase of a clinical trial, from start-up to close-out. For example, some CRAs also evaluate prospective research sites before a study begins to determine the capabilities of the facility and staff. Overall, the CRA is a key player in helping maintain the integrity of a clinical trial by monitoring a site’s practices.