Running head: PHARMACEUTICAL TESTING NURSE: NURSES AS CLINICAL

RESEARCHERS

Pharmaceutical Testing Nurse:

Nurses as Clinical Researchers
Elise Howard
The Pennsylvania State University

PHARMACEUTICAL TESTING NURSE: NURSES AS CLINICAL RESEARCHERS

PHARMACEUTICAL TESTING NURSE: NURSES AS CLINICAL RESEARCHERS

I.

What do they do?

A. Clinical Research Nurse
1. Many levels of nursing
a. LPN, RN, RN with advanced degrees (Poston &
2.
3.
4.
5.

Buescher, 2010)
Principal investigator
Study coordinator
Clinical trials nurse
Staff nurse caring for patients who are research subjects
a. New drugs are constantly entering all phases of
clinical trial testing
b. Need nurses to care for the patient and document all
the effects that tested drugs may be having (Grady &

Edgerly, 2010)
B. Roles and Definition
1. Coordinate day-to-day trial management
a. Staffing support
b. Members necessary for specific trial
c. Risk/benefit for trial
d. Proper patient population available
e. Funding available (Gibbs & Lowton, 2012)
2. Ensure current guidelines and laws are followed (Gibbs &
Lowton, 2012)
a. Is protocol ethically written?
3. Screening, recruitment, and obtaining informed consent
(Gibbs & Lowton, 2012)
a. Recruitment of patients for specific therapies
b. Advocacy for the patients
(1)Risk/benefit for patient
(2)Do they understand risks and other options?
(Grady & Edgerly, 2010)
4. Communication (Gibbs & Lowton, 2012)
a. Many roles that are collaborative with many
disciplines

PHARMACEUTICAL TESTING NURSE: NURSES AS CLINICAL RESEARCHERS

b. Physicians
c. Pharmacologists
d. PT/OT
e. Registration staff
f. Other nursing staff
5. Train (Poston & Buescher, 2010)
a. Registration staff
b. Clinical nursing staff taking care of pt using
experimental drug
c. Pharmacy support staff
6. EDUCATE! you cant get away from it (Gibbs & Lowton,
2012)
a. Education is always a part of nursing
b. Need to education the patient about the drug
c. Need to education the family
d. Need to education the staff (training)
7. Definition? (Gibbs & Lowton, 2012)
a. Job definition there usually is none. Many nurses
find this a very challenging aspect of this career
when they first start.
b. You gain much of your knowledge of job definition

II.

through working
c. NIH initiative CRN2010 next slide
Outlook (Hastings, 2009)
(1)The National Health Institutes established an initiative
(2)Clinical Research Nursing2010 (CRN 2010)
1. Goal of defining a specialty practice of clinical research
nursing
2. Working towards a certification process

III.

Benefits
A. Money! (PayScale, 2014)
1. Median salary pay - $62,255
B. Location, Location, Location (PayScale, 2014)
a. Nationally on the rise
b. Outlook GREAT!
c. Many jobs in New York and California
C. Employed by site (Poston & Buescher, 2010)

PHARMACEUTICAL TESTING NURSE: NURSES AS CLINICAL RESEARCHERS

a. Hospital, university, private medical practice, private

IV.

research facilities
b. Fixed term contracts
D. High autonomy (Gibbs & Lowton, 2012)
E. Collaboration (Gibbs & Lowton, 2012)
F. High level of patient contact (Gibbs & Lowton, 2012)
G. Advocacy to the patient (Gibbs & Lowton, 2012)
H. Intellectually demanding (Gibbs & Lowton, 2012)
I. Teaching (Gibbs & Lowton, 2012)
J. Constant use of skills (Gibbs & Lowton, 2012)
Imagine for a second
A. Alice is a 42-year-old woman with an aggressive cancer that has
not responded to previous therapy. She is offered participation in
a phase one clinical trial with a promising new investigational
agent. Alices nurse knows that the purpose of the trial is to
evaluate the safety of the drug and that the possibility that Alice
might benefit in terms of tumor shrinkage or an increase in the
length or quality of her life is very small. The nurse is concerned
that the principal investigator (PI) has not made this clear
enough to Alice, and is concerned that Alice is not well informed
about what alternatives are available to her. Respecting Alices
right to make her own decision about study participation, the
nurse feels strongly that Alices informed consent may be
compromised. When the nurse raises these concerns, the PI
expresses apprehension about confusing Alice. The nurse
suggests that a multidisciplinary discussion of the options
available for Alice and a plan for assuring she understands the
options would be helpful for everyone. The PI agrees. The nurse
organizes a patient care conference to include the PI, medical
fellow, relevant nursing staff, social worker, spiritual counselor,
and bioethicist. All agree that it would be helpful if the nurse
spent additional time reviewing information about the study with
Alice. After a lengthy and engaging discussion with Alice about
the study and her options, the nurse asks Alice to explain in her
own words what the study is about, what is likely to happen
during the study, and what other choices she has besides
participation. Much more confident that Alice has a better
understanding of the study and is making an informed choice
about participation, the nurse offers continued discussion with
Alice throughout the study (Grady & Edgerly, 2010).
1. Handout for everyone in class
2. This describes how important advocacy for the patients
safety is

PHARMACEUTICAL TESTING NURSE: NURSES AS CLINICAL RESEARCHERS

3. Not only do you advocate for patient safety, this leads to

V.

better practice in pharmaceuticals overall

Wide Variety of Job! (Thomas-Jones & Wilson, 2013)

PHARMACEUTICAL TESTING NURSE: NURSES AS CLINICAL RESEARCHERS

REFERENCES
Grady, C., & Edgerly, M. (2010). Science, technology, and innovation: Nursing
responsibilities in clinical research. Nursing Clinics of North America,
44(4), 471-481. doi:10.1016/j.cnur.2009.07.011
Gibbs, C. L., & Lowton, K. (2012). The role of the clinical research nurse.
Nursing Standard, 26(27), 37-40. Retrieved from
http://web.b.ebscohost.com.ezaccess.libraries.psu.edu/nrc/pdf?
sid=9d68c88a-faa9-4d55-819b65e21a3ee403%40sessionmgr110&vid=6&hid=124
Hastings, C. (2009, April). Clinical Research Nursing 2010. Retrieved from
http://clinicalcenter.nih.gov/nursing/crn/crn_2010.html
PayScale. (2014, September 3). Clinical nurse salary (United States).
Retrieved from
http://www.payscale.com/research/US/Job=Clinical_Research_Nurse/Salar
y
Poston, R. D., & Buescher, C. R. (2010). The essential role of the clinical
research nurse (CRN). Urologic Nursing, 30(1), 55-63, 77. Retrieved
from http://search.proquest.com/docview/236618170?
accountid=13158

PHARMACEUTICAL TESTING NURSE: NURSES AS CLINICAL RESEARCHERS

Thomas-Jones, C., & Wilson, L. L. (2013). Role perception of nurse clinical

research coordinators. Nursing: Research and Reviews, 2013(3), 133139.