Clinical Researcher—December 2017 (Volume 31, Issue 6)
Paula Smailes, MSN, RN, CCRC, CCRP; Holly Bookless, BSN, RN-BC; Carrie Blumenauer, BSN, RN
In August 2016, the American Nurses Association (ANA) formally recognized clinical research nursing as a specialty within the nursing profession. Clinical research nurses are specially trained nurses responsible for safeguarding research subjects, while maintaining the integrity of the research protocol in outpatient and inpatient settings with subjects who are healthy, acute, or chronically ill.1
The International Association of Clinical Research Nurses (IACRN) is a professional organization whose purpose furthers the cause of these nurses by defining, validating, and advancing this specialty practice by supporting the professional development of registered nurses who impact the care of clinical research participants.2 To further define clinical research nursing, the IACRN and the ANA joined forces to develop the scope and standards of practice for research nurses’ efforts to gain the skills to provide safe, accurate, efficient, and ethical care that complies with research regulations.
Professional Advancement in Nursing
“Clinical ladders” are commonly designed as professional development tools to reward nurses for education and certification, research, clinical skills, and leadership.3 The idea behind clinical ladder programs stems from Patricia Benner’s “novice to expert” theory, which centers around the competence of the nurse through stages: novice, advanced beginner, competent, proficient, and expert.4
These programs offer a means for the bedside or staff nurse to advance in the profession. Nursing managers and administration can use ladder programs as means to retain nurses, increase their competency and satisfaction, and increase quality of patient care delivery. Progression up the clinical career ladder is typically conditional upon the nurse meeting defined criteria of clinical excellence, skills and competence, professional expertise, and educational attainment.5
The American Nurses Credentialing Center (ANCC) Magnet Recognition Program® is considered to be one of the international gold standards for quality in healthcare organizations.6 Magnet organizations are known for their superior nursing processes and quality patient care, which ANCC tout as ultimately leading to high levels of safety, quality, and patient satisfaction. The idea behind magnet status is that these organizations can attract and, perhaps more importantly, retain quality nurses.
There are five Magnet Model components that organizations must meet to achieve this designation. These include transformational leadership; structural empowerment; exemplary professional practice; new knowledge, innovation, and improvements; and empirical quality results.7 Some institutions employ clinical ladder models in the three different fields of clinical practice, nursing management, and nursing education.8 The magnet components can be used as the guide for clinical ladders.
Being designated as a magnet hospital means attracting and retaining excellent nurses. Having clinical ladder programs for nurses at a magnet hospital increases this “magnetizing” effect by rewarding nurses with professional advancement at the bedside, recognition from peers and nursing leadership, and (often) financial rewards. Clinical ladder nurses are empowered to make decisions at the bedside, operating at the top of their nursing license and further improving the magnet effect.
While these programs are common outside the clinical research milieu, they are less commonly thought of within the clinical research setting. However, clinical ladders can be adequately transferred to this nursing specialty to serve as a means for career advancement that can ultimately have a positive impact on both research subjects and the research organization.
The purpose of this paper is to overview the experience of a clinical ladder program for clinical research nurses at a federally funded clinical research center based within the academic medical center for which the authors work.
Clinical Research Centers
In 1960, the National Institutes of Health (NIH) established General Clinical Research Centers (GCRC) with funding from the National Center for Research Resources. These are known for providing infrastructure and resources to support career development opportunities.9 In 2006, the funding structure was changed by the NIH, whose goal was to promote basic and clinical research, with subsequent translation to practice via the NIH-funded Clinical and Translational Science Awards (CTSA) program. This change in funding structure led to many centers renaming their GCRCs.
Inpatient centers that are part of the CTSA program are staffed by multidisciplinary teams including physicians and PhD investigators, administrators, nurse managers, nurse practitioners, staff nurses, dietitians, lab personnel, and medical technicians. The clinical research nurses serve as the core resource for these centers, and must execute multiple research protocols in this environment along with data and specimen collection using good clinical practices (GCPs). The clinical research nurse is responsible for moving research protocols from concept to reality at the bedside, while ensuring each encounter is safe and accurate for research participants and accurate for the principal investigators per the approved protocols.
Duties of clinical research nurses are highly varied from center to center, depending on the particular research emphases of each center. Duties may include, for example, extensive inpatient pharmacokinetics with monitoring for side effects and changes in the participants’ condition, simple sample collections, conscious sedation, biopsies, and insulin clamping procedures. Research nurses must be prepared to encounter many different populations with a variety of conditions, including rare diseases and first-in-human agents.
The research nurse is constantly learning new skills while building on prior knowledge from studies initiated in the past. The research nurse is integral to maintaining safety and order within protocol requirements, while promoting retention of the participant through excellent bedside care and supporting the volunteer nature of research studies.
Clinical Ladder Benefits…
…to Clinical Research Centers and Organizations
Some of the primary reasons for organizations to use a ladder program include staff retention, productivity, and job satisfaction.5 As this concept is applied to clinical research programs employing research nurses, its value continues to lie in the ability to offer professional advancement.
The clinical research center at the authors’ organization encourages clinical research staff nurses to participate in the institution’s clinical ladder program. When nurses participate, it allows the healthcare system to recognize clinical nurses, highlighting their advancement and accomplishments. When clinical research nurses contribute to the quality of the center, it in turn becomes a reflection of the organization and enhances research participants’ experiences.
Research nurses who are active in a clinical ladder program contribute to the different complex systems of the center by actively engaging in quality improvement, participant satisfaction and safety, and staff engagement. Being a part of the clinical ladder program elevates research nurses to increased levels of involvement in all of these areas and, in turn, helps engage peers and increases professionalism within the unit. Involvement in unit initiatives is expected and supported for clinical research nurses from those working at the bedside to the top nursing leadership levels in the institution. Importantly, nurses can remain at the bedside with participants while still advancing in the professional role of nursing at the institution.
Clinical research nurses in ladder programs offer fresh ideas for problem-solving and engagement of the team by helping to move through issues to reach resolution. One example in research is related to policies and procedures. Since many clinical research centers have unique activities that may not be institutionally recognized through standard hospital policies, the nurse in a clinical ladder program can be helpful in developing these unit-based policies.
For example, the use of peripheral IVs for frequent blood sampling has been a standard practice around the world at research centers for many decades, but most institutions do not support this activity in standard bedside practices. However, research participants might not be willing to participate in research if they are required to endure venipuncture every 10 minutes for a 10-hour research study. For this reason, developing unit-based policies are important to research units.
The clinical ladder nurse can be helpful in this process by reviewing the literature related to the topic, gathering data on policies from other research centers or research GCP guidelines, writing the policy based on institutional guidelines, ensuring peer review on the unit, and finally, getting approval for the policy from administration so the policy can be put into practice. Not only does this help the unit, but it innately increases the engagement of the clinical ladder nurse and her peers.
The nurse participating in a clinical ladder program also promotes the professionalism required for increases in research participant satisfaction scores. The clinical ladder nurse is on the front line with the research participant, noting trends with different populations and engaging in safety reviews on a regular basis. This is helpful in monitoring metrics and noting if there are immediate issues with different research populations related to both satisfaction and safety.
Because the clinical ladder nurse is on the front line with the research participants, this can help support positive satisfaction scores and healthy outcomes. The authors have found that on their unit, high patient satisfaction scores may be related to this program. In the last year, more than 96% of research participants surveyed in the clinical research center reported having a positive experience with research study participation.
Further, having a nurse involved in clinical ladder promotes staff engagement, as the nurse becomes a positive change agent for the unit. A clinical ladder nurse tends to be fully committed to new processes, and typically is active with new initiatives. This may be related to the personal goals and outcomes that are required when progressing through the different clinical ladder levels. Nurses in the authors’ unit have engaged in quality improvement initiatives and have presented the outcomes at international research conferences via poster presentations.
…to Clinical Research Nurses
There are many reasons why a clinical research nurse should participate in a clinical ladder program for career advancement. One of the most significant is that it creates the opportunity to advance the nurse’s skills and career, while simultaneously allowing the nurse to stay at the bedside.
Research nurses in the authors’ clinical research center continue to provide direct patient care, and can use ladder programs to positively impact their patients by having ownership in improving the quality of patient care. This can be achieved by staying current with practice and doing literature searches, then subsequently incorporating evidenced-based techniques into practice. This may also lead to research nurses publishing and contributing to the evidence in clinical research.
Engaging in a clinical ladder program may also serve as a starting point for nurses who later want to advance in clinical research management. The skills acquired as part of the ladder program can be utilized in leadership positions involving project management, team building, supervisor roles, process improvement, and unit outcomes.
Certification can also be a means to advance up the clinical ladder. Clinical research certifications from professional organizations and their ongoing continuing education opportunities are encouraged by nursing and research administration. Research nurses can be offered time off to complete projects. Certification is a means of validating cognitive knowledge and continued competency—as recommended by the Institute of Medicine—and the most commonly cited reason for attaining certification is public safety.3
Finally, the most enticing benefit of clinical ladders can be increased pay. As clinical research nurses continue to advance up the ladder, this can contribute to more recognition, and with that comes monetary compensation. Clinical research nurse achievement through clinical ladder programs can be further evaluated annually and compensated accordingly.
Clinical ladder programs have been utilized as a competitive marketing strategy in times of nursing turnover and shortage, and have delivered proven impacts on the main stakeholders in healthcare: patients, employers, and nurses.3 Clinical research programs that employ nurses can reap the benefits of clinical ladders, as nurses positively impact the quality of research-related patient care and data collected for study protocols. Having professional development programs like those involving clinical ladders in place encourages employee growth while showing organizational investment in nurses’ careers.
- McCabe M, Lawrence C. 2007. The clinical research nurse. Am J Nursing 107(9):13.
- International Association of Clinical Research Nurses. https://iacrn.org/
- Watts M. 2010. Certification and clinical ladder as the impetus for professional development. Crit Care Nursing Q 33(1):52–9.
- Benner P. 1982. From novice to expert. Am J Nursing 82(3):402–7. http://nursing-theory.org/theories-and-models/from-novice-to-expert.php
- Buchan J. 1999. Evaluating the benefits of a clinical ladder for nursing. Int J Nursing Studies 36:137–44.
- American Nurses Credentialing Center. 2017. AANC Magnet Recognition Program®. www.nursecredentialing.org/Magnet
- Nursing Reference Center. 2017. Gateway to Magnet Status. http://support.ebsco.com/uploads/kb/en_nrc_magnet_helpsheet.pdf?_ga=2.208804306.1997861688.1503779962-266739246.1503779962
- Shi Y, Li J. 2016. Research progress of hierarchical division in nursing ladder management in China. Chinese Nursing Res 3(3):109–12.
- Mori C, Mullen N, Hill E. 2007. Describing the role of the clinical research nurse. Res Pract 8(6):220–8.
Paula Smailes, MSN, RN, CCRC, CCRP, (firstname.lastname@example.org) is a member of the ACRP Editorial Advisory Board, a senior training and optimization analyst for clinical research at The Ohio State University Wexner Medical Center, and a visiting professor with Chamberlain College of Nursing.
Holly Bookless, BSN, RN-BC, (email@example.com) is the nurse manager for the Clinical Research Center at The Ohio State University Wexner Medical Center.
Carrie Blumenauer, BSN, RN, is a research nurse for the Clinical Research Center at The Ohio State University Wexner Medical Center.