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Here's one way to pull your career up to a whole new level of professional growth.
If you're a critical care nurse, you've had the joy of seeing patients respond well to new treatments or drugs, and the deep frustration of losing patients because available treatments weren't effective. Would you like to advance your medical knowledge and nursing practice while growing in your career? If you're detail-oriented, curious, and well organized, you could channel your critical care skills to become a research coordinator.
An investigator oversees the study as a whole. As research coordinator, you keep the project rolling along by coordinating the efforts of those involved, including principal investigators, other team members (such as nursing, pharmacy, lab, and radiology staff), patients, and their families; handling regulatory and financial paperwork; and working with the investigator in overseeing the screening and enrollment of patients and the execution of the study protocol.
Before becoming a research coordinator, you're usually required to complete a course on the protection of human research subjects. Mandatory coursework covers everything from informed consent to research regulations to the ethics of clinical research.
Once you've been hired as a coordinator, you'll begin the process of obtaining institutional review board (IRB) approval for the proposed study. Your duties may include drafting the informed consent document according to IRB guidelines. Budget concerns may require initial meetings with the investigational pharmacist or other ancillary staff. You'll send the IRB an initial submission form that describes the study protocol and includes the informed consent document, a project summary in lay terms, an investigational brochure on any drug or device being tested, a description of protected health information to be used for Health Insurance Portability and Accountability Act (HIPAA) purposes, and samples of advertising to attract potential study subjects.
Once your IRB grants approval (which usually takes a few weeks), you and the investigator may begin screening, recruiting, and enrolling patients, a long process that ensures a sound basis to the study and its results. Patient charts and lab and radiology results help determine which patients are appropriate candidates.
The physician overseeing the study or a member of the study team must obtain informed consent from each patient (or his surrogate) after screening but before enrolling the patient and initiating any study procedures. For each patient enrolled, you'll maintain a detailed case report form (CRF) that includes patient history, other initial information, and daily updates to track patient progress, setbacks, and outcomes.
For accurate study data, the protocol must be followed scrupulously. Because nursing staff play such a central role in protocol execution, you'll need to ensure (through staff development programs) that they know how to perform all tasks required by the protocol. Once the protocol begins, you'll supervise its execution closely. You may even help carry out the protocol yourself to avoid overburdening nursing staff.
Serious adverse events (SAEs), such as death, a life-threatening event, or rehospitalization, must be reported to the IRB. If an industry-sponsored study is taking place at multiple centers, you must report SAEs occurring at any of the sites. Report forms for SAEs require extensive documentation of the event. You must also report to the IRB any modifications whatsoever to the study or its personnel. You'll keep a regulatory binder that includes study-related documentation. In a multicenter study, you may need extra staff to stay on top of regulatory paperwork.
A sponsor-employed clinical research associate will come to review the CRFs-including checking them against patient medical records-and to see that your regulatory binder is complete. You'll need to correct any discrepancies in the CRFs. This time-consuming process is essential should the study ever undergo an audit by the Food and Drug Administration. When the study is over, keep all study-related documents secure for confidentiality. Although you should keep a secured list of patient names and contact information, HIPAA regulations require that identifying information be removed from study data before making the data available for analysis.
As a research coordinator, you can count on gaining a broader perspective on your field and growing professionally.
Agency for Healthcare Research and Quality http://www.ahrq.gov
Food and Drug Administration http://www.fda.gov
Department of Health and Human Services, Office of Research Integrity http://ori.dhhs.gov
Association for the Accreditation of Human Research Protection Programs http://www.aahrpp.org
National Institutes of Health http://www.nih.gov
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