Have you ever wondered how new medicines or medical technology is developed? Before coming to market, medical innovations (medications, devices, and new treatment methods) must undergo vigorous testing. Pharmaceutical companies and medical researchers utilize clinical studies and trials to evaluate the effectiveness of new therapies. However, managing a clinical trial is no easy feat. It is extensive, and it takes an experienced team to accurately conduct a trial from start to finish.
Two essential roles within clinical trials are clinical research coordinators and clinical research associates. What is the difference between the two? This article will tell you everything you need to know about the differences between clinical research coordinators (CRC) and clinical research associates (CRA).
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.
Similarities Between a CRA and a CRC
Although CRCs and CRAs are employed by different entities, there are many similarities in their overarching roles. Both individuals often work very closely together throughout a trial as they each act as the main point of contact for the site and sponsor, respectively. Despite differences in their day-to-day tasks, a CRC and their CRA have the same goals of keeping study patients safe, maintaining strict confidentiality, ensuring the study is carried out properly, and promptly resolving any trial-related issues.
Differences Between a CRA and a CRC
One key difference between the two is that a CRA usually does not interact with patients and will focus on data quality while a CRC does interact with patients and collects data. Additionally, CRCs are under the direction of their PI, but CRAs are part of a team of clinical research professionals working for the trial sponsor. Unlike CRAs, a CRC may also be required to submit regulatory documents to the ethics board, including the site’s annual review reports and any reports of serious adverse events or protocol deviations.
Education & Training:
Another major difference between these two positions is that a CRA is required to have at least a bachelor’s degree or equivalent whereas a CRC can work if they only have a high school diploma. However, depending on the institution, some CRC and CRA positions may prefer those with additional education, such as a master’s degree. The employing institution often provides clinical research training for both CRCs and CRAs, but these are also made available by certain licensing organizations.
Licensing & Certification:
There are different certifications available to CRCs and CRAs, although not every job will make this a requirement. A CRC can become designated as a certified Clinical Research Coordinator by the Association of Clinical Research Professionals. Some positions may also require CRCs to be licensed in phlebotomy or nursing. For CRAs, there are Clinical Research Associate certifications or Clinical Research Professional designations offered by the Society of Clinical Research Associates and the Association of Clinical Research Professionals.
Typically, CRCs are responsible for the conduct and management of clinical trials at one site, whereas CRAs are involved with the regulatory and clinical oversight of multiple sites. CRCs are employed by sites, such as private clinics, hospitals, or research centers, but CRAs can be employed by institutions such as pharmaceutical companies, medical research institutions, contract research organizations, or government agencies. Lastly, although a CRC often is required to work on-site, CRAs can sometimes work from home depending on their duties. However, many CRAs are required to travel to each of their sites regularly to perform monitoring duties in person.
Clinical trials are an essential practice for delivering high-quality evidence-based medical research. At the forefront, CRCs and CRAs play key roles in conducting these studies successfully at the site and sponsor levels, respectively. Despite their differences, both individuals are important figures in clinical research, and both share a passion for facing challenges, self-learning, and advancing medicine.
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