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Clinical research nursing coordination--what is it?

Medical research has been an important element in the vast improvement in human health care in the past century, and academic health centers across the country have played key roles in these efforts. In Vermont, the state's sole academic health center, an alliance of the University of Vermont and Fletcher Allen Health Care, includes research as one of its primary missions. UVM/Fletcher Allen has been the site of a National Institutes of Health-funded General Clinical Research Center (one of approximately 80 in the U.S.) since the mid-1960s, and has had a National Cancer Institute-funded comprehensive cancer center (one of 39 nationally) since the early 1970s.

Six years ago, the Office of Clinical Trials Research was formed at UVM/Fletcher Allen, in order to better coordinate the conducting of quality research at the institutions. The office supports researchers, helps frame the policies around clinical trials, and works with other entities on campus to help make sure trials run as smoothly as possible and in full compliance with all the appropriate rules. Currently, there are approximately 1200 research projects in progress on the campus.

Good research is vital to health care because it provides investigational medicines, therapies, and improved health care to the public. Clinical research serves as the bridge that allows the important laboratory breakthroughs to reach the bedside of patients. Clinical research at an academic health center provides our community with access to new treatments that they might not otherwise have had the option to receive. In return, those community members help provide the necessary data to validate and improve the new therapies, medications, and devices that will help improve health care nationwide.

Quality is key to all research. Quality research provides meticulously recorded and accurate data from which results are interpreted and reported. Quality research practices ensure patient safety during and after a clinical trial, and help prevent dangerous or ineffective therapies from entering the healthcare market. By providing quality, well-trained and certified clinical research nurse coordinators, institutions are helping to ensure good clinical practice in research endeavors.

But what does a clinical research nurse coordinator do? What role does this individual play in health care? A clinical research nurse coordinator is a highly specialized nurse who facilitates and coordinates activities to ensure that research protocols are implemented in the most efficient, safe and appropriate ways. Many years of training are required to attain proficiency as a research nurse coordinator; most of the education for the role is acquired through on-the-job experience and mentoring from colleagues. Undergraduate RN nursing education programs teach research theory, but the practical aspect of the specialty is learned in the field.

Clinical research nurse coordinators must be skilled in effective teamwork, collaboration with multiple team members, research vocabulary, policies and procedures, including local, state and federal regulations, and must possess the ability to concisely document every step taken during a study. Clinical research nurse coordinators must be proficient in the regulations and practices that are part of the Institutional Review Board (IRB), Food and Drug Administration (FDA), the Office for Human Research Protection (OHRP) and the corporate sponsors responsible for the research, as all of these entities impact how the nurse performs her/his responsibilities.

Patient care and safety concerns are priorities in all health care settings; but in the world of research, there is a heightened sensitivity to these issues. We are often working with experimental drugs, practices and devices that are being tested on human subjects for the first time. These drugs and devices are being studied after extensive animal/lab testing has been completed. The need for vigilance in monitoring, observation and assessment (of both the regulatory environment and the patient care arena) makes the responsibilities and work of the clinical research nurse coordinator intriguing and distinct from traditional nursing roles.

Basic clinical skills for clinical research nurse coordinators include: phlebotomy, performing EKG's, delivering investigational medications, patient assessments, vital signs, processing blood samples, packing and shipping lab specimens, and the ability to use study specific equipment. Another aspect of the clinical research nurse coordinator's role is to understand business practices. The clinical research nurse coordinator plays an important role in the business aspect of research, facilitating project implementation by assisting with the review and development of financial plans and budgets, contracts, grants.

In order to provide quality research to our patients and to our communities, it is vital that we have resourceful and experienced research nurse coordinators. Nurses need to have a strong varied background. It takes at least one to two years, in addition to previous nursing experience, to become a proficient research nurse. The Association of Clinical Research Professionals (ACRP), as well as the Society of Clinical Research Associates (SOCRA) requires that a nurse have two years of full-time clinical research experience or four years of part-time clinical research experience in order to be eligible for certification in the field. Research is continuously changing and the clinical research nurse coordinator must stay up-to-date to keep current with ongoing changes in regulations and therapies.

Clinical research nurse coordination is a unique field that needs to be recognized as a separate nursing specialty. There are very few nurses who serve in this role. Some clinical research nurse coordinators specialize in a specific area of research, such as gynecology, cardiology, oncology, or psychiatry; there are others who do research in a variety of disciplines, adapting to the appropriate discipline as each study occurs. A clinical research nurse coordinator works with the research team to ensure that the research is carried out appropriately. All of the clinical research nurse's efforts help to make certain that research therapies which are designed to improve health care and make advancements in the medical field get carried out in a professional manner. Fostering quality research makes a difference in our communities by bringing the most cutting edge and safest treatments to all of our patients, and the clinical research nurse is an important part of this vital effort.

Written in collaboration by the nurses of the Office of Clinical Trials at UVM/Fletcher Allen Health Care
COPYRIGHT 2007 Vermont State Nurses Association, Inc.
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2007 Gale, Cengage Learning. All rights reserved.

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Publication:Vermont Nurse Connection
Geographic Code:1USA
Date:Aug 1, 2007
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