Clinical Research Coordinators: The Glue that Binds a Clinical Research Program
Clinical research coordinators are an incredibly important part of the clinical research process. Their role has continued to evolve in recent years, as clinical trials have continued to grow in complexity. This evolved role has led to better data collection, greater protocol compliance, and overall improved subject safety. Because of their crucial role, many have come to recognize clinical research coordinators as the glue that binds clinical research programs.
Until the early 80s, the role of Principle Investigator (PI) routinely included the roles of the researcher, main patient-care provider, and data manager all at once. As clinical trials became more complex, PIs began to delegate some of these duties to others, which resulted in the need for senior nurses to have an expanded knowledge of the research process. These senior nurses soon redefined their role as “research coordinators”, and began taking on many of the very important clinical research processes.
One of the main parts of the clinical trial process that clinical research coordinators are involved in is the study start-up process. Clinical research coordinators must review the study protocol in detail to extract important elements of clinical and logistical feasibility, and then communicate with the PI to discuss any potential barriers in patient recruitment, study logistics, or data collection.
Clinical research coordinators are crucial in maintaining institutional compliance, and they must review coverage analysis properly to ensure all tests and procedures are properly documented. For some studies, research coordinators must also communicate with the PI to ascertain which tests and procedures are routine care, and which are research-related. After trial milestones are achieved, the research coordinator is responsible for communicating what tests and procedures were performed to ensure billing can be properly adjudicated. Clinical research coordinators are also tasked with guaranteeing that data from studies is properly delivered to the sponsor.
Clinical research coordinators are vital to the patient recruitment and enrollment process, and serve as the link between the patients, the patients care team, and the PI. Research coordinators often pre-screen patients, and they help drive the enrollment process by ensuring that proper informed consent is obtained, all screening activities are achieved, and that all inclusion/exclusion criteria are met before a subject is randomized into a trial. Clinical research coordinators are also uniquely positioned to protect patients, and typically have good relationships with their patients. Clinical research coordinators make sure that patient health information (PHI) is kept secure, and are often exposed to vital patient information. The research coordinator is also in communication with the sponsor teams and study monitors, and receives valuable correspondence on items such as patient safety reports and protocol amendments, which gives them the ability to react quickly to protect the patients.
Clinical research coordinators are a vital part of the clinical research process, and they ensure that studies run smoothly, compliantly, and efficiently. Research coordinators serve as a liaison between the research team, the PI, the patients and the sponsor. They help protect patient health and safety, while also instilling trust and confidence in their patients. Research coordinators serve as the gatekeeper of data, and they have the rigid discipline to follow protocols to ensure that the clinical research process goes smoothly.