Clinical Research Nurse Practitioner: What is it and how to become one?

[DanaBA, BSN, MSN, APRN, NP]

Clinical research and trials are necessary to bring about new drugs, devices, techniques, and technology. Trials are being conducted daily under the guidance of nurse practitioners. Here is an introduction to the role of a clinical research nurse practitioner, as a sub-investigator. 

Today, nurse practitioners (NPs) work in a variety of different areas, including family practice, mental health, acute care, pediatrics, women's health, and countless other specialties. These roles can be quite demanding and stressful leading to burnout resulting in NPs searching for other opportunities. Clinical research can be a less stressful role worth looking into. 

What is Clinical Research?
Clinical research is the comprehensive study of the safety and effectiveness of medications, medical devices, diagnostic tools, treatments, techniques, and technologies utilized to treat and care for patients. Clinical research is important in the advancement of healthcare and the number of trials being conducted is growing tremendously. As a result, more staff are needed to help conduct these trials. 

How is Clinical Research Conducted?
Clinical trials are initiated, managed, and usually financed by sponsors who may be people, institutions, companies, government agencies, or other organizations. Many sponsors contract with local facilities or clinics to conduct studies according to specific guidelines, called protocols. 

A protocol is a research plan that describes the objective, design, methodology, statistical considerations, and all aspects related to the organization and conduction of the trial. The protocol details the following and other pertinent information:
•    Type of patients that may enter the study
•    Specific inclusion/exclusion criteria
•    Required assessments, tests, and/or procedures
•    Medications to be administered, including dosages and frequency
•    Length of the study
•    Number of clinic visits required
•    Adverse reactions to monitor for 

Clinical trial oversight is managed by principal Investigators (PIs), who are responsible for the overall conduct and integrity of the study. The PI is usually a physician but can be a non-physician if the person is qualified to supervise all aspects of the study. NPs who practice in states with full medical practice privileges may be autonomous principal investigators if allowable by the study sponsor. 

NPs who do not work in states with full medical practice authority may work in clinical research as a sub-investigator. Sub-Investigators assist the PI in conducting the clinical trial. 

Responsibilities of Clinical Research NP/Sub-Investigator
Clinical Research NPs work autonomously and collaboratively with the PI, clinic staff, and sponsor to ensure proper enrollment, consent, management, and safety of patients in clinical trials. Responsibilities may vary depending on the sponsor and involvement of the PI. In general, NPs may be responsible for the following:
•    Determine patient eligibility and safety to participate in trial
•    Obtain/verify informed consent
•    Perform physical examinations and document findings
•    Review medical records 
•    Reconcile medications
•    Administer investigational product via IM, SQ, IV
•    Phlebotomy
•    Interpret labs and diagnostic tests
•    Assess adverse events and determine causality to investigational product
•    Perform minor procedures
•    Refer patients to primary care provider/specialist
•    Complete clinic and sponsor required trainings
•    Educate staff and patients

Education and License Requirements
•    Bachelor of Science in Nursing
•    Master's degree or equivalent experience and satisfactory completion of NP licensure
•    Current RN and NP licensure in state of practice
•    Current Prescription authority and Drug Enforcement Agency (DEA) certification
•    NP Board Certification 
•    Current CPR certification

Knowledge, Skills, and Abilities
•    At least one year of experience as a nurse practitioner
•    Ability to follow clinical protocol and comply with study procedures
•    Ability to perform duties listed above
•    Effective communication skills

Clinical Trial Therapeutic Areas
Therapeutic areas of research are vast but could included the following:
•    Cancer
•    Alzheimer's disease
•    Vaccinations
•    Infectious diseases
•    Neurological disorders
•    Orthopedics
•    Endocrine
•    Liver disease
•    Cardiology
•    Obstetrics/gynecology
•    Pediatrics
•    Geriatrics