1
00:00:12,000 --> 00:00:15,348
>> Stephanie Burrison: Hello.
My name is Stephanie Burrison.

2
00:00:15,348 --> 00:00:18,151
I'm a supervisory nurse
research specialist

3
00:00:18,151 --> 00:00:21,254
with the Office of Research
Support and Compliance.

4
00:00:21,254 --> 00:00:23,323
Today, I'll be giving
you an overview

5
00:00:23,323 --> 00:00:25,191
of a research
nurse coordinator.

6
00:00:25,925 --> 00:00:29,295
Some goals for this session
are to define research nursing,

7
00:00:30,263 --> 00:00:32,932
understand the differences
between a bedside nurse

8
00:00:32,932 --> 00:00:34,534
and a clinical
research nurse,

9
00:00:35,435 --> 00:00:37,771
recognize the roles
and responsibilities

10
00:00:37,771 --> 00:00:39,706
of a research nurse,

11
00:00:39,706 --> 00:00:43,243
and learn a different aliases
for a research nurse.

12
00:00:45,578 --> 00:00:48,715
Clinical research
nurses have many roles.

13
00:00:48,715 --> 00:00:51,484
I may not cover all the
roles in this session,

14
00:00:51,484 --> 00:00:53,953
but just remember
clinical research nursing

15
00:00:53,953 --> 00:00:56,523
is one profession
with many roles.

16
00:00:58,725 --> 00:01:01,027
So, what is a
research nurse?

17
00:01:01,027 --> 00:01:04,998
A research nurse supports
research by partnering

18
00:01:04,998 --> 00:01:07,767
with patients in support
of their participation

19
00:01:07,767 --> 00:01:09,736
in clinical research.

20
00:01:09,736 --> 00:01:12,439
Research nurses
implement and coordinate

21
00:01:12,439 --> 00:01:14,407
clinical research protocols

22
00:01:14,407 --> 00:01:17,877
and conduct independent and
collaborative research.

23
00:01:19,946 --> 00:01:23,583
Clinical Research Nursing:
Understanding the Differences.

24
00:01:24,217 --> 00:01:27,353
In addition to providing and
coordinating clinical care,

25
00:01:28,254 --> 00:01:31,291
clinical research nurses
have a central role

26
00:01:31,291 --> 00:01:32,892
in ensuring
patient safety,

27
00:01:33,693 --> 00:01:36,162
ongoing maintenance
of informed consent,

28
00:01:36,830 --> 00:01:39,632
integrity of
protocol procedures,

29
00:01:39,632 --> 00:01:42,101
and accuracy of research
data collection.

30
00:01:43,069 --> 00:01:46,105
Clinical research nurses
must continually balance

31
00:01:46,105 --> 00:01:49,809
the individual clinical needs
of research participants

32
00:01:49,809 --> 00:01:52,879
and protocol requirements
as they practice

33
00:01:52,879 --> 00:01:56,583
while assuring consistency
of baseline treatment

34
00:01:56,583 --> 00:01:59,986
and monitoring across
participants within a study.

35
00:02:03,490 --> 00:02:05,625
There's -- with clinical
research nurses,

36
00:02:05,625 --> 00:02:08,127
you'll see clinical care
for research subjects,

37
00:02:08,695 --> 00:02:11,798
collaborates with research
training and career development

38
00:02:11,798 --> 00:02:14,334
and all combined
with nursing research.

39
00:02:14,934 --> 00:02:18,438
Some practice areas, you may
see clinical research nurses

40
00:02:19,072 --> 00:02:23,243
in inpatient/outpatient
units, such as Med/Surg,

41
00:02:23,243 --> 00:02:27,747
Behavioral Health, Pediatrics,
Oncology Hematology,

42
00:02:28,348 --> 00:02:32,852
Alcohol clinic,
Radiation Oncology, Ears,

43
00:02:32,852 --> 00:02:36,489
Nose & Throat Clinic,
Allergy & Infectious

44
00:02:36,489 --> 00:02:39,759
Disease clinic,
Clinical Genetics

45
00:02:39,759 --> 00:02:41,694
and Dermatology clinic,

46
00:02:41,694 --> 00:02:44,130
Cardiology clinics,
and Dental clinics.

47
00:02:44,898 --> 00:02:47,534
And some day-hospitals
such as Pediatrics,

48
00:02:47,534 --> 00:02:50,136
Med/Surg, and
Hematology/Oncology.

49
00:02:52,539 --> 00:02:57,544
In 2007, Nursing and Patient
Care Services at the NIH

50
00:02:57,544 --> 00:03:00,113
launched a four-year
strategic plan

51
00:03:00,113 --> 00:03:01,981
to lead an
international effort

52
00:03:01,981 --> 00:03:06,252
to define the specialty practice
of clinical research nursing.

53
00:03:06,252 --> 00:03:09,222
Clinical research nursing
is nursing practice

54
00:03:09,222 --> 00:03:10,456
with a specialty

55
00:03:10,456 --> 00:03:13,760
focused on the care of
research participants,

56
00:03:14,427 --> 00:03:17,664
developing tools to support
the specialty practice

57
00:03:17,664 --> 00:03:22,602
of clinical research nursing,
documentation and clarification

58
00:03:22,602 --> 00:03:25,004
of the practice of
clinical research nursing,

59
00:03:25,605 --> 00:03:27,674
and consensus
around steps

60
00:03:27,674 --> 00:03:30,543
leading to possible
national certification.

61
00:03:31,678 --> 00:03:34,447
Now, there are
research organizations

62
00:03:34,447 --> 00:03:37,617
such as the International
Association of Clinical Research

63
00:03:37,617 --> 00:03:41,287
Nurses, also
known as IACRN;

64
00:03:42,088 --> 00:03:43,890
the Association of
Clinical Research

65
00:03:43,890 --> 00:03:46,593
Professionals,
known as ACRP;

66
00:03:47,193 --> 00:03:50,263
and the Society of Clinical
Research Associates

67
00:03:50,263 --> 00:03:51,998
also known as SOCRA,

68
00:03:51,998 --> 00:03:54,267
which offers
continuing education

69
00:03:54,267 --> 00:03:56,836
and research and
certification exams

70
00:03:56,836 --> 00:03:58,805
to get certified
in research.

71
00:04:00,907 --> 00:04:03,610
Here's a specialty
practice domain

72
00:04:03,610 --> 00:04:07,113
where you'll see nurses
contributing to Science,

73
00:04:07,113 --> 00:04:09,816
Clinical Practice,
Human Subjects

74
00:04:09,816 --> 00:04:13,653
Protection, Study
Management, Care,

75
00:04:13,653 --> 00:04:16,723
and Coordination &
Contiguity of Care.

76
00:04:16,723 --> 00:04:19,325
This is some scopes of
Clinical Research Nursing.

77
00:04:21,294 --> 00:04:22,996
Here is a Clinical Ladder

78
00:04:22,996 --> 00:04:25,965
where you'll see some nurses
start with an undergraduate

79
00:04:25,965 --> 00:04:27,567
as an undergraduate student.

80
00:04:28,134 --> 00:04:32,472
Then they'll lead to a new
grad, clinical research nurse,

81
00:04:33,406 --> 00:04:34,874
go up to a study
coordinator

82
00:04:34,874 --> 00:04:38,344
or a case manager,
advanced practice nurse

83
00:04:38,344 --> 00:04:40,446
where you'll see some
nurse practitioners,

84
00:04:40,980 --> 00:04:43,383
pre-doctoral and
doctoral students,

85
00:04:44,283 --> 00:04:45,885
post-doctoral training.

86
00:04:46,552 --> 00:04:49,622
And at the top, you'll see
clinical nurse scientists.

87
00:04:50,590 --> 00:04:52,692
These are the
variety of roles

88
00:04:52,692 --> 00:04:55,294
you can see clinical
research nurses in.

89
00:04:57,463 --> 00:04:59,332
Nurses in clinical research.

90
00:04:59,999 --> 00:05:03,036
As a clinical specialty,
clinical research

91
00:05:03,036 --> 00:05:05,672
nursing incorporates
the two main roles

92
00:05:05,672 --> 00:05:09,842
assumed by nurses practicing
in clinical research settings.

93
00:05:10,543 --> 00:05:13,680
Clinical research nurse,
also known as a CRN,

94
00:05:14,380 --> 00:05:17,250
and a research nurse
specialist, RNS.

95
00:05:18,184 --> 00:05:21,454
Some aliases for the
research nurse specialist

96
00:05:21,454 --> 00:05:23,056
is research
nurse coordinator,

97
00:05:23,856 --> 00:05:27,460
clinical trials nurse,
study coordinator,

98
00:05:28,327 --> 00:05:32,765
clinical research nurse,
clinical research coordinator,

99
00:05:33,566 --> 00:05:35,568
and clinical
research care nurse.

100
00:05:36,235 --> 00:05:37,970
There are some
study coordinators

101
00:05:37,970 --> 00:05:40,206
that are not
research nurses.

102
00:05:40,206 --> 00:05:43,042
This presentation is
specifically focusing

103
00:05:43,042 --> 00:05:45,211
on clinical research nurses.

104
00:05:47,980 --> 00:05:50,383
Nurses in Clinical Research.

105
00:05:50,383 --> 00:05:54,454
Just as investigators,
nurses also balance a patient

106
00:05:54,454 --> 00:05:57,390
participant needs with the
protocol requirements.

107
00:05:58,091 --> 00:06:01,594
Nurses in research have the
responsibility of advocating

108
00:06:01,594 --> 00:06:05,765
for the patient so they are safe
and their welfare is protected.

109
00:06:06,566 --> 00:06:09,001
Nurses spend the most
time with patients.

110
00:06:09,001 --> 00:06:11,571
So, it's critical that
we share information

111
00:06:11,571 --> 00:06:14,040
with the participant
in the study team

112
00:06:14,040 --> 00:06:15,975
to ensure their protections.

113
00:06:17,043 --> 00:06:20,079
Research nursing versus
clinical research nurse,

114
00:06:20,079 --> 00:06:22,081
what's the difference?

115
00:06:22,081 --> 00:06:24,917
Research nurse coordinators
may be initiator

116
00:06:24,917 --> 00:06:28,221
and/or facilitator for the
informed consent process,

117
00:06:29,455 --> 00:06:32,391
may provide indirect care
through research participants,

118
00:06:33,359 --> 00:06:34,594
help with coordination

119
00:06:34,594 --> 00:06:37,330
and scheduling
protocol-specific activities,

120
00:06:38,664 --> 00:06:40,867
help assure data
collection specific

121
00:06:40,867 --> 00:06:42,468
to protocol requirements,

122
00:06:43,569 --> 00:06:46,038
and help with adverse
event reporting

123
00:06:46,038 --> 00:06:47,640
and regulatory monitoring.

124
00:06:48,775 --> 00:06:51,410
Clinical research nurse
may provide direct care

125
00:06:51,410 --> 00:06:55,782
to research participants with
the protocol implementation,

126
00:06:57,049 --> 00:07:00,520
data collection, assuring
informed consent,

127
00:07:01,788 --> 00:07:04,624
implementation of
protocol-specific procedures,

128
00:07:05,391 --> 00:07:07,260
and balance to
individual clinical

129
00:07:07,260 --> 00:07:09,195
needs with protocol
requirements.

130
00:07:10,229 --> 00:07:12,532
As you can see, both
roles are very similar

131
00:07:12,532 --> 00:07:15,268
and some nurses may
function in both roles.

132
00:07:18,271 --> 00:07:21,073
The primary responsibility
of a research nurse

133
00:07:21,073 --> 00:07:24,644
is to coordinate daily
activities of the trial,

134
00:07:25,444 --> 00:07:27,613
hands-on control
of the trial.

135
00:07:29,382 --> 00:07:31,050
When it comes down
to a research nurse,

136
00:07:31,050 --> 00:07:32,852
they're basically the PIs,

137
00:07:32,852 --> 00:07:35,521
the principal
investigator's right hand.

138
00:07:35,521 --> 00:07:39,058
They have a huge responsibility
to support their investigator,

139
00:07:39,592 --> 00:07:41,961
as you'll see in the
next few slides.

140
00:07:43,429 --> 00:07:45,298
Some responsibilities
of research

141
00:07:45,298 --> 00:07:49,502
nurses include
coordinate study,

142
00:07:50,603 --> 00:07:54,674
recruiting, screening
and scheduling patients,

143
00:07:55,842 --> 00:08:02,648
securing informed consent,
study conduct, initiation,

144
00:08:02,648 --> 00:08:04,684
monitoring, and
closeout visits,

145
00:08:05,818 --> 00:08:09,922
coordination of lab pickups
and assists with lab supplies,

146
00:08:10,723 --> 00:08:15,595
maintain integrity of protocol,
and maintain regulatory files.

147
00:08:18,831 --> 00:08:21,334
Also, they assist the
principal investigator

148
00:08:21,334 --> 00:08:24,604
in preparing protocols and
consent for initial review,

149
00:08:25,204 --> 00:08:29,775
continue review and amendments.
Help with timely submissions,

150
00:08:30,343 --> 00:08:32,245
help meet regulatory
requirements,

151
00:08:33,145 --> 00:08:34,814
make sure the
data is accurate,

152
00:08:35,715 --> 00:08:37,984
help with reporting
adverse events,

153
00:08:38,751 --> 00:08:40,720
timely and complete.

154
00:08:41,454 --> 00:08:43,990
They help with maintaining
participant records

155
00:08:43,990 --> 00:08:46,826
and documentation
including case report forms,

156
00:08:47,760 --> 00:08:51,964
clinical care, drug preparation,
and drug administration,

157
00:08:52,865 --> 00:08:56,035
and data management
and quality assurance.

158
00:09:00,473 --> 00:09:03,442
Some other research nurse
responsibilities include

159
00:09:03,943 --> 00:09:08,214
teaching patients & staff,
help with the abstract,

160
00:09:08,214 --> 00:09:11,450
analyze & publish findings
with the principal investigator.

161
00:09:12,818 --> 00:09:15,454
They stay informed with
the principal investigator

162
00:09:15,454 --> 00:09:18,624
of new information regarding
investigational agents.

163
00:09:19,825 --> 00:09:22,461
They help with the
investigator's brochures,

164
00:09:22,461 --> 00:09:26,532
articles, help with safety
reports in any memos,

165
00:09:27,633 --> 00:09:30,703
prepare and help facilitate
monitoring of trials

166
00:09:31,404 --> 00:09:36,275
and help resolve discrepancies,
common goals, and timelines.

167
00:09:40,980 --> 00:09:43,549
They anticipate the
deadlines and data needed.

168
00:09:44,350 --> 00:09:47,420
Help with continuing reviews
and any FDA updates,

169
00:09:48,187 --> 00:09:52,792
professional meeting abstracts.
Helps with sponsor audits.

170
00:09:53,826 --> 00:09:56,696
Help review previous
publications and reports.

171
00:09:57,863 --> 00:10:01,467
Helps with data tables,
charts, or graphs, scan images.

172
00:10:02,234 --> 00:10:04,670
And also, mentor other
Research Nurses.

173
00:10:06,339 --> 00:10:09,075
Research nurse
coordinators multitasks.

174
00:10:09,075 --> 00:10:11,110
So, here is the
day in the life

175
00:10:11,110 --> 00:10:13,379
of a research coordinator
that you may see.

176
00:10:14,046 --> 00:10:16,382
You may see them
in inpatient rounds.

177
00:10:16,382 --> 00:10:21,153
You see them at the clinic.
Follow-ups with participants,

178
00:10:21,153 --> 00:10:22,655
with their principal
investigators,

179
00:10:22,655 --> 00:10:24,357
and with sponsors.

180
00:10:24,357 --> 00:10:27,927
Provide phone calls,
screening participants,

181
00:10:28,828 --> 00:10:31,130
data management activities,

182
00:10:31,130 --> 00:10:34,133
and assisting with the
monitoring and audit visits.

183
00:10:35,167 --> 00:10:37,770
Roles based on
different responsibilities

184
00:10:37,770 --> 00:10:39,772
within the research team.

185
00:10:39,772 --> 00:10:42,174
We have the clinical
research nurse coordinator

186
00:10:42,708 --> 00:10:44,443
and the research
nurse coordinator.

187
00:10:45,011 --> 00:10:48,280
And both helps with
clinical practice,

188
00:10:48,781 --> 00:10:52,852
human subjects protection,
contribution to the science,

189
00:10:52,852 --> 00:10:55,554
care coordination and
continuity of Care,

190
00:10:55,554 --> 00:10:57,056
and study management.

191
00:10:57,056 --> 00:11:00,526
And as you can see, both
roles do the same thing

192
00:11:00,526 --> 00:11:02,561
but they have different
responsibilities

193
00:11:02,561 --> 00:11:05,197
and the weight of
each role may differ.

194
00:11:07,666 --> 00:11:11,237
The protocol coordinator
workload may include

195
00:11:11,237 --> 00:11:12,838
protocol development,

196
00:11:13,806 --> 00:11:17,410
such sas assistance with writing
and developing new protocols

197
00:11:17,410 --> 00:11:19,712
for new and established
investigators,

198
00:11:20,513 --> 00:11:23,249
guiding and mentoring
new investigators.

199
00:11:23,983 --> 00:11:27,353
Data entry may assist
with entry of current

200
00:11:27,353 --> 00:11:31,791
and historical data,
potential for trend analysis,

201
00:11:31,791 --> 00:11:35,194
and potential new information
for future studies.

202
00:11:36,295 --> 00:11:40,699
Protocol coordination helps
with the screening, recruiting,

203
00:11:41,434 --> 00:11:45,171
CRIS coordination, and providing
institutional knowledge.

204
00:11:46,005 --> 00:11:49,875
Regulatory support help
with IRB submissions,

205
00:11:49,875 --> 00:11:51,710
including continuing reviews,

206
00:11:51,710 --> 00:11:55,481
initial review of the
study and amendments,

207
00:11:55,481 --> 00:11:58,684
and resource for
regulatory updates.

208
00:12:02,188 --> 00:12:06,125
In 2018, American
Nurses Association,

209
00:12:06,125 --> 00:12:08,761
ANA, recognized
clinical research

210
00:12:08,761 --> 00:12:11,764
nursing as a specialty
nursing practice.

211
00:12:12,832 --> 00:12:16,335
Our success is determined
by the quality of services

212
00:12:16,335 --> 00:12:19,271
we provide to others
and to ourselves.

213
00:12:20,673 --> 00:12:24,276
Quality is the result of an
excellent work culture,

214
00:12:24,276 --> 00:12:26,946
open and effective
communication,

215
00:12:26,946 --> 00:12:30,916
and learning from one another
with constructive feedback.

216
00:12:33,686 --> 00:12:35,254
Here are some questions.

217
00:12:36,388 --> 00:12:39,658
Number one, you have to
be certified in research

218
00:12:39,658 --> 00:12:45,331
in order to be a research
nurse coordinator. False.

219
00:12:45,331 --> 00:12:47,633
You do not have to be
certified in research

220
00:12:47,633 --> 00:12:49,835
in order to be a research
nurse coordinator.

221
00:12:50,636 --> 00:12:57,209
Number two, research nurses
only work at hospitals. False.

222
00:12:57,943 --> 00:13:00,613
Research nurses have
a variety of roles

223
00:13:00,613 --> 00:13:02,982
and they do not only
work at hospitals.

224
00:13:04,416 --> 00:13:06,552
Number three,
research nursing

225
00:13:06,552 --> 00:13:09,155
is not recognized
as a sub-specialty?

226
00:13:10,523 --> 00:13:14,860
False. Research nurse is now
recognized as a sub-specialty.

227
00:13:16,061 --> 00:13:19,765
Thank you so much for listening.
Hope you have a great day.