Steps to Becoming a Clinical Trials Research Nurse - Education & Experience

Clinical research is the process of using science to better determine powerful and inventive means of detecting, diagnosing, treating, and preventing diseases and conditions. Clinical trials research nurses help outline trial criteria, write SOPs, evaluate research methods for efficacy, assist MDs or nurse practitioners with live procedures related to their studies, and deepen our collective medical understanding.

The international research community thrives on clinical research nursing. Research nurses are typically responsible for obtaining participants’ consent and recruiting, educating, and monitoring them. Additionally, these professionals report to the lead physician or NP and often coordinate the direct administration and evaluation of those treatments.

Some organizations use the term “clinical trials research nurse,” and others use the abbreviation “CRN.” Due to confusion concerning acronyms, most professional organizations use the former. Regardless of how you identify the position, no one can deny that as the Baby Boomers age, greater resources will be required to study the wide variety of medical problems that this generation faces.

Clinical research nurses maintain the quality, integrity, and honesty of clinical trials in both the public and private sectors, ensuring they comply with local, state, federal, and international regulations. They are often responsible for monitoring and checking in with study participants, completing test procedure paperwork, and structuring follow-up practices. These professionals develop and implement innovative solutions with numerous applications for the betterment of humankind and tackle some of our longest-running questions about human health. As students, prospective clinical trials research nurses study the components of nursing research, nursing theory, and how to evaluate the validity of the research properly.

Keep reading to learn how to become a clinical trials research nurse. Concentrating one’s studies on research nursing means joining the ranks of a small but significant quadrant of the research community.

Before graduating from high school, there are many ways that students can prepare for a career as a research nurse in clinical trials. It is recommended that to help prepare for coursework in clinical nursing and research, one should take a wide variety of courses in anatomy, physiology, mathematics, geometry, algebra, chemistry, physics, speech, and psychology. As admission to nursing programs is highly competitive, students are advised to pursue advanced placement coursework and set a goal of maintaining as high a grade point average as possible.

Another way to gain insight into the medical field is to intern at an extended care facility, nursing home, clinic, or teaching hospital. Volunteering, too, can be an excellent way to gain new perspectives on health, care, and nursing theory.

An associate’s degree in nursing (ADN) lays a clinical research and theoretical foundation for the work that one will undertake. Introductory coursework in anatomy, physiology, biology, nursing theory, and many more establish a skillset that blends the technical, technological, and medical.

Upon completion of two-year coursework, students will have received one of the following degrees: associate of nursing (AN), an associate of science in nursing (ASN), an associate degree in nursing (ADN), or an associate of applied science in nursing (AASN). Any of these degrees can prepare you to qualify for the NCLEX-RN exam.

Herzing University

The ASN program at Herzing University offers an accelerated, fast-paced course of study for those students wishing to achieve brisk entry into the industry. Students can complete this program in 20 to 24 months, depending on whether they have any transfer credits. General education courses are offered online, while core classes require on-campus attendance.

Made up of 70 to 73 credits, the program includes courses such as fundamentals of nursing; adult nursing systems; therapeutic use of self; pharmacology; nursing process and documentation; nursing management; mental health nursing; family nursing; and medical-surgical nursing.

• Location: Akron, OH; Birmingham, AL; Nashville, TN; Orlando, FL; Tampa, FL
• Accreditation: Higher Learning Commission (HLC)
• Expected Time to Completion: 20 to 24 months
• Estimated Tuition: $695 per credit

A BSN might be the best path for those interested in diving deeper into clinical trials research nursing. These courses of study build on the basics learned in an associate’s program, focusing on upper-level classes on research theory, nursing practice, and human resource management. At this stage, some aspiring CRNs seek concentrations focusing on clinical trials or research.

Schools such as the University of Michigan and the University of Washington boast top-notch BSN programs.

University of Michigan

The University of Michigan’s bachelor of science program in nursing provides students with a rigorous yet rewarding education filled with unique opportunities that will prepare them to become nurses and thrive as leaders in the field.

Comprising 128 credits, the program includes courses such as the culture of health; pathophysiology; reproductive health; behavioral health; health assessment; human anatomy and physiology; applied statistics; care of the family: infants, children, and adolescents; role transition; and leadership for professional practice.

• Location: Ann Arbor, MI
• Accreditation: Higher Learning Commission (HLC)
• Expected Time to Completion: Four years
• Estimated Tuition: Michigan resident ($1,046 to $1,133 per credit); non-resident ($2,654 to $2,815 per credit)

University of Washington

The University of Washington offers a bachelor of science in nursing (BSN) program preparing students for careers as registered nurses. Students in this program will learn from nationally acclaimed faculty members using interactive scenarios. They will learn to practice nursing skills in safe environments before performing them in supervised clinical settings.

Under the guidance of licensed care providers, students in this program will gain more than 1,000 hours of hands-on patient care experience. Students start in this program as college-level juniors after having already completed 60 semester-credits or 90 quarter-credits at the college level or a previous bachelor’s degree in a non-nursing field.

The curriculum includes courses such as foundational skills for professional nurses; foundations of professional nursing practice; foundations in pharmacotherapeutics and pathophysiology; fundamentals of nursing practice for illness care; health equity; healthcare systems and policy; ambulatory care; psychosocial nursing in health and illness; child health; and care coordination and case management.

• Location: Seattle, WA
• Accreditation: Commission on Collegiate Nursing Education (CCNE); Higher Learning Commission (HLC)
• Expected Time to Completion: Two years
• Estimated Tuition: Resident ($4,081 quarterly); non-resident ($13,580 quarterly)

Each state requires that that state’s respective licensing channels must license those intending to become nurses. This directory collates data on how and where to obtain nursing licensing in all 50 states. Some states require a notarized personal statement or letter of intent with application paperwork.

The NCLEX-RN exam is the American testing standard for all registered nurses. After applying for the exam and offering proof of educational credentials, and meeting all state-specific criteria, nascent nurses must schedule an appointment to take the exam.

Administered by nursing professionals in closed exam rooms on isolated terminals, the exam uses machine learning to adapt its questions to the subject, specialization, and skill set. In some states, all of this work (including the exam) can be completed before a student’s official graduation date. This helps to expedite a nurse’s transition from student to practicing professional. Check state, institution, and employer policies before deciding on this approach.

Additionally, many certificates in clinical research, nursing science, and nursing research can be obtained online and added to one’s credential portfolio. For example, the University of Pittsburgh’s School of Nursing offers a certificate in nursing informatics.

Work experience in clinical trials can be critical to obtaining a clinical trials research nurse job. Many employers expect applicants to have already worked in this field. There are numerous ways to gain the necessary work experience, including working in administrative roles in trials, completing an internship, or working as a nursing assistant.

While much less common in customer and public care, advanced degrees in nursing are critical for those who wish to find a place in the leadership of clinical trials and research nursing.

Expanding on the foundations laid in a nursing BS program, an MS with a concentration in clinical research sciences often takes two or three years. Coursework covers clinical research theory, nursing theory, practicums in various healthcare and research environments, research development and coordination, clinical trial management, experiment design, and evidence-based practice, among other subjects. An MS in clinical research nursing positions students to transition into careers as research leads and assistants in pharmaceuticals, consumer products, clinical pathology, virology, oncology, and the study of infectious diseases.

Aside from nursing programs, there are also excellent master’s in clinical research degrees that nurses can complete to gain the necessary education to enter this field.

George Washington University

For example, George Washington University’s online MSHS in clinical and translational research is an excellent option for those looking to continue their education online. For a more traditional pathway, GW also hosts an on-campus clinical and translational research program that has been widely lauded.

The online MSHS program explores clinical administration, biomedical science, health policy, and community health. Graduates learn to develop best practices for bringing the latest medical science findings to the patients. This online program has no residency requirement.

The program’s 36-credit curriculum includes courses such as critical analysis of clinical research; clinical investigation; foundations in clinical and translational research; grantsmanship in translational health science; bioinformatics for genomics; biostatistics for clinical and translational research; and epidemiology translational research, among others.

• Location: Washington, DC
• Accreditation: Middle States Commission on Higher Education (MSCHE)
• Expected Time to Completion: Two years
• Estimated Tuition: $1,315 per credit

There are two doctoral nursing degrees available, both of which are terminal, meaning that no further paths of education are available to those who hold these degrees. While a doctor of nursing practice (DNP) is a clinical practice degree intended for advanced nurse practitioners, a PhD in clinical research and trials nursing requires pursuing and studying an area of expertise that results in a doctoral dissertation and its defense.

Some advanced nursing programs will accept a BSN as a satisfactory degree when students apply for graduate school. However, the industry standard is to obtain an MSN before entering advanced postgraduate nursing studies. Always remember to contact an institution’s admissions office and check in to their criteria for application.

William Carey University

William Carey University offers a cutting-edge PhD in nursing science. This doctor of philosophy program in nursing education is a terminal degree that prepares DNP graduates to serve as nurse educators and nurse scholars. Except for four weekend meetings per year, this program can be completed entirely online and is a convenient option for full-time working students.

The curriculum includes courses such as role development for the nurse educator; curriculum development and program planning; instructional strategies and evaluation of student learning; creating an online educational environment; advanced curriculum assessment and evaluation; research development; advanced research methodology; and program evaluation.

Applicants to the program must hold a DNP from an accredited school of nursing, a GPA of 3.0, a current unencumbered nursing license, and submit three reference forms, among other requirements.

• Location: Hattiesburg, MS
• Accreditation: Southern Association of Colleges and Schools Commission on Colleges (SACSCOC)
• Expected Time to Completion: Two years
• Estimated Tuition: $610 per trimester hour

Texas Woman’s University

Texas Woman’s University boasts two doctoral nursing programs: one in nursing science and one allowing students who have already obtained a DNP to extend their education and gain a clinical PhD. These programs can be completed either online at the Denton campus or in a hybrid format at the Houston campus.

In the nursing science PhD program, students receive the investigative aptitude, management skills, and advanced nursing knowledge needed to earn a spot at the healthcare leadership table, whether at hospitals, classrooms, or clinical settings. Admission requirements to this program include a current unencumbered U.S. RN license, a bachelor’s or master’s degree in nursing from a nationally accredited program, and a minimum GPA of 3.0.

The PhD in nursing science program requires completion of 60 credits beyond the master’s and includes courses such as philosophy of nursing science; ethical dimensions of nursing; exploring scientific literature; measurement and instrumentation in nursing research; qualitative nursing research; theory for nursing research and practice; quantitative nursing research; and determinants of health.

The DNP-to-PhD bridge program requires the completion of 42 credits. Applicants to this program must have a current unencumbered U.S. RN license, show evidence of graduation from a DNP program offered by a regionally-accredited university with national certification in nursing preferred, and have a minimum GPA of 3.5.

• Location: Denton, TX
• Accreditation: Southern Association of Colleges and Schools Commission on Colleges (SACSCOC)
• Expected Time to Completion: Two to four years
• Estimated Tuition: $7,140 per semester

University of Central Florida

For those seeking an online degree, the University of Central Florida offers a nursing PhD that has built a web-based curriculum around two on-campus intensives each year. This online PhD prepares graduates for careers at the forefront of nursing science, where they will be contributing to the body of knowledge and leading research in the application of innovative strategies for nursing education and clinical care.

The program requires the completion of 63 credits beyond the master’s degree. Those without an MSN degree should pursue the BSN-to-PhD in nursing program. The BSN-to-PhD program requires the completion of 72 credits beyond a bachelor’s degree.

• Location: Orlando, FL
• Accreditation: Southern Association of Colleges and Schools Commission on Colleges (SACSCOC)
• Expected Time to Completion: 11 to 15 semesters
• Estimated Tuition: In-state ($288.16 per credit); out-of-state ($1,073.31 per credit)

Certification through the Association of Clinical Research Professionals (ACRP) demonstrates to employers that the candidate has achieved a high level of competency in clinical research education and training. Clinical trials research nurses can earn two primary certifications: a Certified Clinical Research Associate (CCRA) or a Certified Clinical Research Coordinator (CCRC).

The eligibility requirements for either certificate are the same. Candidates must have 3,000 hours of work experience in the six content areas of clinical research trials. A formal education program may substitute for up to 1,500 hours of work experience.

The content of the exams is similar and includes scientific concepts and research design, ethical and participant safety considerations, product development and regulation, clinical trial operations (GCPSs), study and site management, and data management and informatics. While the exam topics are similar, the CCRC exam is more in-depth and covers more advanced material than the CCRA.

Many valuable resources are available for prospective research nurses, from non-profits to representative organizations to job boards. Below are some of the most useful resources for those wishing to pursue a career pathway as a clinical trials research nurse:

• Association of Clinical Research Professionals
• Center for Information & Study on Clinical Research Participation
• Clinical Trial Resources (ASCO)
• Council for the Advancement of Nursing Science
• Global Research Nurses
• National Institute of Nursing Research
• NCLEX Registered Nurse Practice Test Questions
• Oncology Nursing Society’s FAQs
• Society of Clinical Research Associates
• Eastern Nursing Research Society (ENRS)
• The Midwest Nursing Research Society (MNRS)
• Southern Nursing Research Society (SNRS)
• The International Association of Clinical Research Nurses (IACRN)