Authors

  1. Paglione, Melanie MCR, BSN

Abstract

These nurses conduct activities to support clinical research.

 

Article Content

Growing up, I had the opportunity to watch my aunt working as an RN in a downtown dedicated children's ED. The nurses there were always alert and ready to help others, and I realized I wanted to be one too. After nursing school, I worked as a bedside nurse in a hospital, and then in family practice. During that time, I witnessed the needs of patients from underprivileged and underserved populations-people who needed the most help but who were hindered by the many social determinants of health. A passion to help people and find new ways to prevent, treat, and cure illness-not just for individual patients but for whole populations across the life span-was what drew me to become a clinical research nurse (CRN).

  
Figure. Melanie Pagl... - Click to enlarge in new windowFigure. Melanie Paglione

What we do. Clinical research nursing focuses on the care of the research participant and the fidelity of the research study. The specialty was endorsed by the American Nurses Association in 2016 with the publication of Clinical Research Nursing: Scope and Standards of Practice. CRNs conduct a variety of activities to support clinical research. We assist with enrolling and randomizing study participants; obtain informed consent; complete study visits, during which we may administer medication, perform assessments, and take vital signs; collect blood, nasopharyngeal swabs, or urine specimens; and carry out procedures with the principal investigator. The CRN conducts data collection and data entry into electronic databases. We may perform regulatory tasks such as ensuring everyone is trained properly and documents are correct and approved by the institutional review board. Overall, the CRN is responsible for holding the highest ethical standards and abiding by study protocols, as well as for providing input on the care of study participants to ensure their safety.

 

Career opportunities. RNs are well qualified for CRN positions, and may pursue one in their specialty area, such as cardiology, infectious disease, primary care, or pediatrics. From academic medical centers to pharmaceutical and contract research organizations, the opportunities are endless. There are several certification programs, each with different requirements, such as having a portfolio (a record of professional and academic work) or passing an examination, but all require work experience in the research field for two years before the evaluation. Most CRNs seek credentials from the Society of Clinical Research Associates or Association of Clinical Research Professionals. Recently, the International Association of Clinical Research Nurses (IACRN) began offering board certification by portfolio. There are also bachelor's, master's, and academic certificates specifically in clinical research.

 

Challenges. Although CRNs generally earn higher salaries than their nonlicensed counterparts on the research staff, salaries can depend on geographic location. A long-term staff RN may take a salary cut to move to a CRN position; however, the hours for CRNs may be more desirable, often Monday through Friday, 8 to 5. Another challenge is our job title. There has been a national call from the American Nurses Association, the IACRN, and others to standardize job titles and progression pathways for CRNs, but human resource departments are slow to make these changes. Similarly, when RNs renew their licenses, there is no checkbox for the career CRN, so it's difficult to get an accurate idea of our numbers. Another challenge is the scope of CRN practice versus that of a clinical staff nurse. Generally, in terms of patient care, the roles are quite similar; however, there are specific protocols that need to be followed to the letter for research to be valid. Therefore, CRNs may feel they must balance providing safe, ethical, quality care to participants while abiding by standards, regulations, and study protocols.

 

Connecting with colleagues. For more information and resources, consider browsing the IACRN website (https://iacrn.org). There are also several publications on the CRN role on websites such as PubMed. Also, the Food and Drug Administration website has a plethora of information and training about CRNs. Drug sponsors, device manufacturers, and academic medical centers are also good resources for job opportunities and knowledge in this field. Finally, talk to a CRN-they will tell you all about this rewarding career path and fill you with stories about their positive impact on the clinical research enterprise.