Clinical Research Nurses: Roles and Qualifications in South Korea

Ihnsook Jeong
Assistant Professor,
College of Nursing, Pusan
National University
Hyun-Sook Kang
Professor, College of Nursing,
Kyung Hee University
Won-Ock Kim
Professor, College of Nursing,
Kyung Hee University
Key Words
Clinical research nurse;
Role;
Qualification
This study was supported
by the Pusan National
University Grant.
Correspondence Address
Ihnsook Jeong, College
of Nursing, Pusan National
University, 1ga Ami-dong,
Seo-Gu, Busan, 602-739
South Korea (e-mail:
jeongis@pusan.ac.kr).
Clinical Research Nurses: Roles and
Qualifications in South Korea
This study aimed to determine the standard
roles, proficiency, and qualification of clinical
research nurses (CRNs) in clinical trials/research
in South Korea. Seventy-one investigators
with experience working with CRNs and
79 current CRNs were conveniently sampled.
Data were collected using a questionnaire including
demographics, perceived roles, proficiency,
and qualification of CRNs. The top
three roles of CRNs perceived by investigators
were scheduling subjects, communicating with
investigator and sponsor, and completing case
INTRODUCTION
Since 1990, the Korean government has heavily
invested in the development of new drugs in order
to be independent of foreign drug development
(1). This investment has increased expectations
for the increase of domestic clinical
trials (2). The number of clinical trials has necessitated
the development of a proper infrastructure
to improve the quality of the nation’s
clinical trials to those of advanced countries.
Thus, to secure the credibility of clinical trials
and to protect participating subjects, the Korea
Good Clinical Practice (KGCP) was established
in 1995 and was revised in 2000 following International
Conference on Harmonisation GCP.
While legal and systematic infrastructure have
been established to a certain extent, a proper infrastructure
for human resources, which is the
most important aspect of clinical trials, has not
yet been established. This situation has led to a
shortage of qualified professionals in clinical
trials (3).
Clinical research nurses (CRNs) are professional
nurses who have a substantial amount of
responsibility for clinical trials and are required
to conduct the clinical trials according to the
principle investigator’s instructions (4,5). Phar-
Drug Information Journal, Vol. 41, pp. 251–256, 2007 • 0092-8615/2007
Printed in the USA. All rights reserved. Copyright © 2007 Drug Information Association, Inc.
MEDICAL INFORMATION
report forms. The top three roles of CRNs perceived
by current CRNs were completing case
report forms, communicating with investigator
and sponsor, and screening subjects . The most
important proficiencies perceived by investigator
and current CRNs was communication
and human relationship skills. Both investigators
and current CRNs considered the key role
of CRNs as communicating with investigator
and sponsor; a bachelor’s degree and more
than one year of clinical experience were seen
as the minimum qualification.
251
macists and laboratory technicians can also assist
the principal investigators in conducting
clinical trials; they are collectively known as
clinical research coordinators (CRCs) (4,6).
CRCs are generally preferred to have knowledge
of both medicine and pharmacology as well as
knowledge of the clinical trial itself, which
makes nurses the best-qualified candidates for
this position. In fact, most CRCs are CRNs so
that CRCs are commonly called CRNs and vice
versa (6).
Positions for CRNs were only established in
the mid-1990s in South Korea, so a professional
infrastructure has not been systematically developed.
Specifically, the roles and responsibilities,
education, and career qualifications of
CRNs have not been been specified. In addition,
most CRNs are working for low salaries and at
unstable positions, which has resulted in a high
turnover rate (7).
Because the success of clinical trials depends
on well-designed research and meticulous and
careful execution (5), the roles and qualifications
of CRNs, who spend most of their time
with the subjects through the entire process of
the clinical trials, are very important. This fact is
especially true since the principal investigators,
who are usually doctors, cannot spend all of

252 MEDICAL INFORMATION
Jeong, Kang, Kim
their time on the clinical trial, which leaves the
CRNs to spend most of their time on the clinical
trial (8–10).
Regarding this background, it is necesary to
set up standards for the role and qualifications
of CRNs in South Korea.
METHODS
STUDY DESIGN
This was a descriptive study to identify the roles
and qualification of CRNs in South Korea.
STUDY SUBJECTS
Study subjects were 71 investigators and 79 current
CRNs. We sent a one-page questionnaire to
93 investigators from 77 institutions authorized
by the Korean Food and Drug Administration.
This was to determine those who had experience
working with CRNs; among them, 71 investigators
were selected as study subjects.
Since there were no organizations or associations
for CRNs in South Korea, and most work
temporarily for an institution or investigator, it
was very difficult to find and select CRNs. Thus,
three methods were used to select subjects.
First, a list of CRNs who had completed the
training course offered by Seoul National University
Hospital Clinical Trial Center was obtained,
and those individuals were contacted by
e-mail or telephone. This initial set of contacts
formed the basis for snowball sampling. Second,
the clinical trial managers for Contract Research
Organizations (CROs) or pharmaceutical
companies were contacted for referrals. Third,
administrators of Web sites popular with CRNs
were able to supply lists of CRNs. Using these
methods, 79 CRNs working in hospitals, pharmaceutical
companies, and CROs were selected
as subjects.
INSTRUMENTS
The study instrument was a self-report questionnaire
developed by the research team because
of the absence of a valid and reliable instrument
regarding this topic. One of the
researchers who had worked as a CRC prepared
the draft questionnaire, and content validity was
established by a pilot study. It was confirmed after
a revision based on results of the pilot test.
The contents were largely composed of three
sections for a total of 12 items: general characteristics
of the subjects, roles and responsibilities
of CRNs, and education and career in clinical
setting qualifications of CRNs. Each item
was answered by either checking the appropriate
response or writing a short opinion.
DATA COLLECTION
A questionnaire containing the purpose and
contents of the research was mailed to the investigators
and returned by mail. CRNs were first
contacted by phone and received the questionnaire
through e-mail. The completed questionnaire
was returned either through e-mail or mail.
DATA ANALYSIS
The collected data were coded and were analyzed
using Windows SPSS (version 10.0) for frequency
and percentage or mean and standard
deviation. The χ 2 test was used to examine
whether there were differences between investigators
and current CRNs in the perceived roles,
skills, and qualifications of CRNs at the .05 level
of significance for two-tailed tests.
RESULTS
GENERAL CHARACTERISTICS
OF THE SUBJECTS
Of the 71 investigators, 83.1% were males, their
average age was 38.7 years old, 94.4% had a
master’s degree, and their average career in clinical
trials was 6.0 years. Of the 79 CRNs, 79 were
female, and their average age was 30.9 years old.
Approximately 85% received degrees at the
bachelor’s level and above, and their average career
in clinical trials was 1.4 years (Table 1).
ROLES OF CLINICAL RESEARCH NURSES
The top five roles of CRNs as perceived by the
investigators were scheduling subjects (93.0%),
communicating with investigator/sponsor
(87.3%), completing case report forms (CRFs)
(83.1%), collecting data (80.3%), and obtaining
informed consent (76.1%) (Table 2).

Clinical Research Nurses in South Korea MEDICAL INFORMATION 253
The top five roles of CRNs as perceived by current
CRNs were completing CRFs (87.3%), communicating
with investigator/sponsor (84.8%),
screening subjects (82.3%), monitoring and reporting
adverse events (79.7%), and preparing
study-related materials (79.7%).
Both groups showed different opinions on a
few roles of CRNs. This was statistically different
in the recruiting subject (P < .05), screening
subjects (P < .01), scheduling subjects (P < .01),
and preparing the monitoring visit and inspection
(P < .05).
SKILLS AND ATTITUDE NEEDED
Investigators showed that CRNs should be educated
in communication and human relationships
(53.5%), have passion for work (36.6%),
and have management and organizational skills
(31.0%). Similar to the investigators, current
CRNs showed that CRNs should be educated in
communication and human relationships
(44.3%), have good basic nursing skill (29.1%),
Drug Information Journal
General Characteristics Generof
Study Subjects
and have passion for work and management and
organizational skills (21.5%) (Table 3).
EDUCATIONAL AND CAREER
QUALIFICATIONS
The qualifications for CRNs were classified into
education background and clinical background.
Both sets of study subjects preferred
the bachelor’s degree and one to three years of
clinical experience (Table 4).
DISCUSSION
This study was performed to set up standards for
the role and qualifications of CRNs by surveying
the opinions of investigators and current CRNs
in South Korea.
Bowen and Rice (4) classified the roles of
CRNs as clinical coordinator, nursing care
provider, educator and counselor, and subject
advocate. The role of clinical coordinator implies
that the CRN is the administrator who assesses
and controls the resources of the clinical
Characteristics Investigator (n = 71) CRNs (n = 79)
Gender Male 59 (83.1) 0 (0.0)
Female 12 (16.9) 79 (100.0)
Age (years) 20–29 8 (11.3) 38 (48.1)
30–39 35 (49.3) 34 (43.0)
40–49 20 (28.2) 6 (7.6)
≥50 8 (11.3) 1 (1.3)
Mean ± SD 38.7 ± 7.8 30.9 ± 4.9
Education Junior college 0 (0.0) 12 (15.2)
College (4 year) 4 (5.6) 46 (58.2)
Master’s 10 (14.1) 20 (25.3)
Doctoral 57 (80.3) 1 (1.3)
Career in clinical trial (years) ≤1 17 (23.9) 43 (54.4)
CRNs, clinical research nurses.
1.1–3.0 18 (25.4) 30 (38.0)
3.1–5.0 9 (12.7) 5 (6.3)
≥5.1 27 (38.0) 1 (1.3)
Mean ± SD 6.0 ± 5.9 1.4 ± 1.2
TABLE 1

254 MEDICAL INFORMATION
Jeong, Kang, Kim
TABLE 2
TABLE 3
Roles Investigator (n = 71) CRNs (n = 79) χ2
Preparing initiation meeting 47 (66.2) 61 (77.2) 2.25
Preparing study-related materials 49 (69.0) 63 (79.7) 2.28
Preparing timeline of clinical trial 34 (47.9) 47 (59.5) 2.03
Budgeting 17 (23.9) 20 (25.3) 0.04
Reviewing protocol and CRF 45 (63.4) 51 (64.6) 0.02
Recruiting subjects 25 (35.2) 41 (52.0) 4.23*
Obtaining informed consent 54 (76.1) 62 (78.5) 0.13
Screening subject 45 (63.4) 65 (82.3) 6.83 †
Making random assignments 26 (36.6) 36 (45.6) 1.24
Scheduling subject 66 (93.0) 59 (74.7) 8.99 †
Collecting data (specimen) 57 (80.3) 60 (75.9) 0.41
Monitoring and reporting adverse event 53 (74.6) 63 (79.7) 0.56
Communicating with investigator/sponsor 62 (87.3) 67 (84.8) 0.20
Completing CRF 59 (83.1) 69 (87.3) 0.54
Preparing for monitoring and inspection 54 (76.1) 45 (57.0) 6.08*
Assist investigator’s personal job 8 (11.3) 18 (22.8) 3.46
CRF, case report form.
*P < .05; †P < .01.
Roles of Clinical Research Nurses (CRNs) as Perceived by the Study Subjects
trial, including the pharmaceuticals, equipment,
facilities, and human resources, before
and during the trial. The role of nursing care
provider implies that the CRN must execute, assess,
and record the study process and report
adverse events or experiences and toxic reac-
tions as soon as possible. The role of educator
and counselor implies that the CRN must explain
all of the pertinent information regarding
the test to the subject and his or her family. Finally,
the role of subject advocate means that
the CRN must clarify the purpose and level of
Skills and Attitude Needed for Clinical Research Nurses (CRNs) as Perceived by the Study Subjects*
Skills and Attitude Needed Investigator (n = 71) CRNs (n = 79) χ2
Basic nursing care skills 16 (22.5) 23 (29.1) 0.84
Communication and human relationship skill 38 (53.5) 35 (44.3) 1.27
Humanity 7 (9.9) 4 (5.1) 1.27
Management and organizational skills 22 (31.0) 17 (21.5) 1.74
Scientific thinking 12 (16.9) 14 (17.7) 0.02
Ethical thinking 15 (21.1) 15 (19.0) 0.11
Passion for work 26 (36.6) 17 (21.5) 4.17 †
*Selected two items among seven items.
† P < .05

Clinical Research Nurses in South Korea MEDICAL INFORMATION 255
Qualifications for Clinical Research Nurses Gener (CRNs) as Perceived by the Study Subjects
expectations from the subject and subject’s family
while obtaining an informed consent.
More than half of the respondents thought
that the roles and work that were fit for CRNs included
collecting research data, contacting the
researcher and client, opening and participating
in initiation meetings, educating and obtaining
informed consent, reviewing protocols
and CRFs, contacting the subject and managing
their schedules, preparing for monitoring and
inspection, monitoring and reporting adverse
events, completing CRFs, preparing researchrelated
materials, screening subjects, planning
the research schedule, and recruiting subjects.
According to Ganter and Bednaz’s study,
CRNs usually collect data on adverse events
from subjects (93.0%), screen the subjects
(92.0%), educate subjects (86.1%), recruit the
subjects (82.8%), and manage the subject’s
schedule (81.5%), whereas completing the CRFs
was only included by 15.8% (6), which suggests
some inconsistencies with the results of this
study. These differences are thought to have occurred
because of the differences in the range of
CRNs’ activities, differences in the amount of
work taken on from principal investigators, and
differences in cultural backgrounds.
The roles of educator and counselor and nursing
care provider require the CRN to have communication
and human relationship skills and
extensive basic nursing skills (10,11). The role of
Drug Information Journal
Qualification Investigator (n = 71) CRNs (n = 79) χ2
Education Registered nurse (RN) 17 (23.9) 14 (17.7) 1.69
Bachelor + RN 33 (46.5) 37 (46.8)
Master’s degree + RN 7 (9.9) 11 (13.9)
Training course + RN 12 (16.9) 13 (16.5)
Other 2 (2.8) 4 (5.1)
Career (years)

256 MEDICAL INFORMATION
Jeong, Kang, Kim
experience with a master’s degree in nursing or
higher. In South Korea, nursing students can
take the research methodology and statistics
course in undergraduate years, but these are not
regarded as major courses, and only a few
showed interest in them. Therefore, CRNs
should have a minimum of a bachelor’s degree
and more as registered nurses and have a minimum
of two years of clinical experience.
CONCLUSION
Although the specific tasks allocated to CRNs
may differ according to the commitments made
by the principal investigators, CRNs should play
a key role in communicating with investigators
or sponsors; therefore, communication and human
relationship are the most important skills
for CRNs. However, budgeting, recruiting of
subjects, and making random assignments can
be excluded as CRNs’ roles in South Korea.
CRNs need to have minimum of a bachelor’s degree
and over one year of clinical experience.
REFERENCES
1. Shin SG. Current status and prospective in domestic
clinical trials. Korean Health Industry Development
Institute Forum; 2003.
2. Lee DH. Current policy related to the clinical tri-
No potential conflict of interest was reported by the authors.
als and development strategies. Korean Health
Industry Development Institute Forum; 2003.
3. Kang HS, Kim WO, Jeong IS, Jeong SY, Shin SS.
Developing infrastructure of clinical trial in Korea.
Korean Food and Drug Administration Report;
2004.
4. Bowen KE, Rice LS. Who is clinical research
nurse? Res Nurse. 1998;4:1–4.
5. Carpentier WS. Clinical research nurse career
ladder. Res Nurse. 1998;4:1–13.
6. Ganter J, Bednaz S. CRA and CRC salary survey.
Appl Clin Trials. 1998;7:38–50.
7. Kang HS, Kim WO, Jeong IS, Paek JM. The working
conditions and clinical trial practice of research
nurses. Clin Nurs Res. 2004;9:41–55.
8. Adams J. The role of research nurse. Nurs Times.
1994;90:70–72.
9. Campbell T. Patient-focused care: primary responsibilities
of research nurses. Br J Nurs. 1998;
7:1405–1409.
10. Gano JB, Kleinerman ES. Administration of liposomal
MTP-PE by the local physician: the role
of the research nurse. Cancer Pract. 1995;3:42–
48.
11. Tomamichel M, Jaime H, Degrate A, et al. Proposing
phase I studies: patients’, relatives’, nurses’
and specialists’ perceptions. Ann Oncol. 2000;11:
289–294.
12. Saunders C. Job description and performance
evaluations. Res Nurse. 1999;5:1–22.