Editor’s note: This article is the last in a four-part series on clinical trials written by nurses at the National Cancer Institute. Visit www.AmericanNurseToday.com to read the other articles: Are you ready to care for patients in clinical trials?, Clinical trials 101, and Care of clinical trial participants: What nurses need to know.
Renee Jorgenson began her nursing career as a staff nurse on a general surgical unit. There she had little exposure to clinical research, with only one clinical trial conducted on her unit; she found it odd that she had to keep the used syringes containing the investigational drug. In her next position as a nurse manager on an oncology unit, several patients were enrolled in clinical trials. As manager, she reviewed the protocol to assess its feasibility for implementation on the unit. Though the task was fairly straightforward, Renee didn’t feel totally comfortable or confident with her clinical trials knowledge. In her next foray into clinical trials, she served as a research nurse for phase I oncology clinical trials. In this role and through on-the-job training, Renee came to understand the clinical trials process and discovered she had a passion for the role of research nurse coordinator.
Like Renee, nurses have many opportunities in clinical research besides that of direct caregiver or nurse researcher. As the field of clinical research expands and evolves, the demand for highly trained and qualified research professionals is growing. With additional education in clinical research, nurses can take on various unique, satisfying, and challenging roles. This article addresses career opportunities for nurses in clinical research, education and training programs, and professional organizations and certification.
Nurses’ roles in clinical research
The traditional roles of direct care provider and nurse scientist are familiar to most nurses. But within the clinical research enterprise, nurses may assume roles that may be new to them, including research coordinator, manager, or educator. (See Traditional roles for nurses in clinical research by clickingthe PDF icon above.)
Nurses also can be found in less traditional roles, such as study monitor, regulatory specialist, and Institutional Review Board (IRB) administrator.
- Study monitors. These professionals monitor clinical research practices onsite for compliance with research regulations and protocols. Potential job titles are clinical research associate and monitor. Potential employers include sponsors, such as private and public funding organizations (for instance, government agencies, academic medical centers, pharmaceutical and biotechnology companies, device manufacturers, and contract research organizations). Self-employment is another option.
- Regulatory specialists. These individuals perform a wide variety of activities related to regulatory document preparation and communication with regulatory authorities. Potential job titles include regulatory coordinator, regulatory operations coordinator, and regulatory affairs specialist. Potential employers are the same as for the study monitor role, listed above.
- Institutional review board (IRB) administrators. These professionals are responsible for oversight, administration, implementation, and management of all IRB activities, including policies and procedures related to protection of the rights and welfare of human subjects. Potential job titles include human subjects protection administrator. Potential employers include local IRBs (for example, universities, academic medical centers, and hospitals), commercial or independent IRBs, and central IRBs (which provide review services for multiples sites in a clinical trial). Specific role implementation and titles may vary among organizations, especially for the research coordinator role.
Education and training
Nurses have a professional obligation to engage in lifelong learning and to be actively involved in their continuing education and professional development. Those involved in clinical research have a unique opportunity to expand their knowledge in two distinct areas (disease specialty and clinical research practices) when selecting educational activities.
Historically, nurses assuming clinical research roles have learned on the job. But the rapidly expanding clinical research environment and its demand for highly trained research professionals have led to numerous graduate and certificate programs in clinical research management. These programs may offer postgraduate certificates or graduate degrees in clinical research management. Many have been developed within nursing schools; others are in schools of health services/sciences. Some of these programs are conducted through distance learning with a modest amount of onsite class time. An Internet search using such key phrases as "clinical research management" and "clinical research management programs" is a quick way to find these opportunities.
In addition, many continuing education courses are available through employers, professional organizations, and clinical research consulting companies or organizations. Again, Internet searches for "study coordinator training" or "clinical research coordinator training" can point you to many options. The Food and Drug Administration and the Office of Human Research Protection also offer educational programs.
Professional organizations and certification
Nurses interested in entering the clinical research field can find professional organizations that provide networking opportunities, continuing education options (such as conferences, webinars, publications, and discussion groups), and other online resources.
Certification—the formal recognition of one’s expertise—is based on specific criteria with established parameters that reflect assessment of educational preparation and knowledge, skills, and abilities or competence developed through experience in a specialty area. Based on their roles, nurses in clinical research have opportunities to receive certification through the:
- Association for Clinical Research Professionals (Certified Clinical Research Associate or Certified Clinical Research Coordinator)
- Society for Clinical Research Professionals, Inc. (Certified Clinical Research Professional).
The clinical research enterprise gives nurses opportunities for professional advancement they may not have explored before. By capitalizing on their healthcare background and communication and critical-thinking skills, they can expand their career opportunities in this exciting specialty.
Visit www.AmericanNurseToday.com for a complete list of references.
The authors work at the National Cancer Institute of the National Institutes of Health. Elizabeth Ness is director of staff development at the Center for Cancer Research. Linda K. Parreco and Annette Galassi are public health advisors in the Office of Communication and Education. Ann M. O’Mara is head of palliative care research in the Community Oncology and Prevention Trials Research Group.