Clinical Research Coordinator

During the conduct of the trial, constant communication between sponsor, vendor, inveshgator and investigahon teams is critical. There is real value in this process, particularly if all parties uhlize a Clinical Trial Management Software System (CTMS) that coordinates all trial activities involving the Clinical Research Coordinator (CRC) at the site and the project managers at the sponsor and CRO locations. 

Clinical research coordinators (CRCs) are the research personnel who assist with pahent visits, and perform study-related procedures that do not require a physician (phlebotomy, vital signs, adverse event, and concomitant medicahon discussions, etc.). CRCs provide the PI or physician with data required for interpretation, medical decisions (inclusion/exclusion, dosage adjustment, patient withdrawal, adverse event causality, etc.), and trial oversight. In addition, CRCs are usually responsible for transcribing source documentation (medical records, clinic notes, laboratory reports, etc.) into case report forms (CRF) supplied by the study sponsor. 

It is agreed in Japan that the key person for the successful conduct of clinical trials is the clinical research coordinator (CRC), equivalent to the study nurse or study coordinator. Despite lack of history of such a role and rather rigid labour environment in Japan, the concept of CRC is now well established and introduction of the CRC to hospitals is gradually progressing. 

Staff qualifications and availability The investigators study coordinators (also called research nurses, clinical research coordinators (CRCs), or study nurses) play a key role at the investigational site. Their availability and experience are assessed because they screen and enroll subjects, complete subjects case report forms (CRFs), maintain source documents, follow and assess subjects throughout the study, and have more interactions with the CRA and representatives of the pharmaceutical study during study conduction. 

Research Associates (SoCRA), an organization with chapters in some half-dozen countries. The ACRP certification is known as Certified Clinical Research Coordinator (CCRC), and SoCRA s certification is the Certified Clinical Research Professional (CCRP). 

Among the staff members it is essential that an investigator appoint a study coordinator (sometimes referred to as the research nurse, clinical research coordinator, (CRC), or study nurse) who plays a key role in the execution of the clinical trial as a direct support to the principal investigator. Therefore careful consideration should be given to their qualifications and research experience. 

ACP Associates of Clinical Pharmacology (USA), a group that certifies clinical research associates (CRAs) and clinical research coordinators (CRCs)... 

CCRC Certified Clinical Research Coordinator. See also AC P. 

The Association of Clinical Research Professionals (ACRP) holds two certification exams, one for Clinical Research Coordinator (CRC), and another for Clinical Research Associate (CRA). 

Clearly, a balanced program that gives careful consideration to the limitations of using CROs — to run the studies, provide the statistical analyses, monitor the processes, and even, coordinate the studies performed outside the United States — needs to be evaluated against the more traditional approaches to drug development. The CRO in clinical research is discussed in detail in Chapter 21. 

Clinical research associates who coordinate and monitor the phase 1, 2, and 3 studies and ensure that the appropriate documents, such as case report forms, are correctly prepared... 

Because the framework of every clinical research study relies on a number of interdependent disciplines, the development of a clinical study protocol is ideally a multidisciplinary task. Teamwork, coordinated by one experienced person in clinical research with good knowledge of the regulatory requirements for new drug development, is essential. The protocol design team should also include input, recommendations, and review by the following ... 

The study coordinator is generally considered the linchpin in the day-to-day activities of clinical research. Without this key individual, sites would be hard pressed to perform studies in a quality and timely fashion because the coordinator s responsibilities define clinical trial conduct. 

Today s quality sites often encourage study coordinators to become certified either by the Association of Clinical Research Professionals (ACRP), an international organization with chapters in more than a dozen nations, or the Society of Clinical... 

A major issue in clinical research today is that of the overwhelmed study coordinator. Because of the ever growing number of details that comprise clinical studies, coordinators can easily become bogged down and, ultimately, very frustrated. This situation can lead to a decline in work quality or a high level of employee turnover. According to a recent survey, 53% of study coordinators have been in their jobs for three years or less (Borfitz, 2004). This poses real challenges in terms of experience level, knowledge of GCP and familiarity with site operations. 

Develop medication use evaluation criteria and other quality improvement measures to assess the use of drug therapy by other providers. Design, conduct, and coordinate clinical research projects under FDA guidelines and procedures of the institutional review board. 

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