>> Stephanie Burrison: Hello. My name is Stephanie Burrison.
I'm a supervisory nurse research specialist
with the Office of Research Support and Compliance.
Today, I'll be giving you an overview
of a research nurse coordinator.
Some goals for this session are to define research nursing,
understand the differences between a bedside nurse
and a clinical research nurse,
recognize the roles and responsibilities
of a research nurse,
and learn a different aliases for a research nurse.
Clinical research nurses have many roles.
I may not cover all the roles in this session,
but just remember clinical research nursing
is one profession with many roles.
So, what is a research nurse?
A research nurse supports research by partnering
with patients in support of their participation
in clinical research.
Research nurses implement and coordinate
clinical research protocols
and conduct independent and collaborative research.
Clinical Research Nursing: Understanding the Differences.
In addition to providing and coordinating clinical care,
clinical research nurses have a central role
in ensuring patient safety,
ongoing maintenance of informed consent,
integrity of protocol procedures,
and accuracy of research data collection.
Clinical research nurses must continually balance
the individual clinical needs of research participants
and protocol requirements as they practice
while assuring consistency of baseline treatment
and monitoring across participants within a study.
There's -- with clinical research nurses,
you'll see clinical care for research subjects,
collaborates with research training and career development
and all combined with nursing research.
Some practice areas, you may see clinical research nurses
in inpatient/outpatient units, such as Med/Surg,
Behavioral Health, Pediatrics, Oncology Hematology,
Alcohol clinic, Radiation Oncology, Ears,
Nose & Throat Clinic, Allergy & Infectious
Disease clinic, Clinical Genetics
and Dermatology clinic,
Cardiology clinics, and Dental clinics.
And some day-hospitals such as Pediatrics,
Med/Surg, and Hematology/Oncology.
In 2007, Nursing and Patient Care Services at the NIH
launched a four-year strategic plan
to lead an international effort
to define the specialty practice of clinical research nursing.
Clinical research nursing is nursing practice
with a specialty
focused on the care of research participants,
developing tools to support the specialty practice
of clinical research nursing, documentation and clarification
of the practice of clinical research nursing,
and consensus around steps
leading to possible national certification.
Now, there are research organizations
such as the International Association of Clinical Research
Nurses, also known as IACRN;
the Association of Clinical Research
Professionals, known as ACRP;
and the Society of Clinical Research Associates
also known as SOCRA,
which offers continuing education
and research and certification exams
to get certified in research.
Here's a specialty practice domain
where you'll see nurses contributing to Science,
Clinical Practice, Human Subjects
Protection, Study Management, Care,
and Coordination & Contiguity of Care.
This is some scopes of Clinical Research Nursing.
Here is a Clinical Ladder
where you'll see some nurses start with an undergraduate
as an undergraduate student.
Then they'll lead to a new grad, clinical research nurse,
go up to a study coordinator
or a case manager, advanced practice nurse
where you'll see some nurse practitioners,
pre-doctoral and doctoral students,
post-doctoral training.
And at the top, you'll see clinical nurse scientists.
These are the variety of roles
you can see clinical research nurses in.
Nurses in clinical research.
As a clinical specialty, clinical research
nursing incorporates the two main roles
assumed by nurses practicing in clinical research settings.
Clinical research nurse, also known as a CRN,
and a research nurse specialist, RNS.
Some aliases for the research nurse specialist
is research nurse coordinator,
clinical trials nurse, study coordinator,
clinical research nurse, clinical research coordinator,
and clinical research care nurse.
There are some study coordinators
that are not research nurses.
This presentation is specifically focusing
on clinical research nurses.
Nurses in Clinical Research.
Just as investigators, nurses also balance a patient
participant needs with the protocol requirements.
Nurses in research have the responsibility of advocating
for the patient so they are safe and their welfare is protected.
Nurses spend the most time with patients.
So, it's critical that we share information
with the participant in the study team
to ensure their protections.
Research nursing versus clinical research nurse,
what's the difference?
Research nurse coordinators may be initiator
and/or facilitator for the informed consent process,
may provide indirect care through research participants,
help with coordination
and scheduling protocol-specific activities,
help assure data collection specific
to protocol requirements,
and help with adverse event reporting
and regulatory monitoring.
Clinical research nurse may provide direct care
to research participants with the protocol implementation,
data collection, assuring informed consent,
implementation of protocol-specific procedures,
and balance to individual clinical
needs with protocol requirements.
As you can see, both roles are very similar
and some nurses may function in both roles.
The primary responsibility of a research nurse
is to coordinate daily activities of the trial,
hands-on control of the trial.
When it comes down to a research nurse,
they're basically the PIs,
the principal investigator's right hand.
They have a huge responsibility to support their investigator,
as you'll see in the next few slides.
Some responsibilities of research
nurses include coordinate study,
recruiting, screening and scheduling patients,
securing informed consent, study conduct, initiation,
monitoring, and closeout visits,
coordination of lab pickups and assists with lab supplies,
maintain integrity of protocol, and maintain regulatory files.
Also, they assist the principal investigator
in preparing protocols and consent for initial review,
continue review and amendments. Help with timely submissions,
help meet regulatory requirements,
make sure the data is accurate,
help with reporting adverse events,
timely and complete.
They help with maintaining participant records
and documentation including case report forms,
clinical care, drug preparation, and drug administration,
and data management and quality assurance.
Some other research nurse responsibilities include
teaching patients & staff, help with the abstract,
analyze & publish findings with the principal investigator.
They stay informed with the principal investigator
of new information regarding investigational agents.
They help with the investigator's brochures,
articles, help with safety reports in any memos,
prepare and help facilitate monitoring of trials
and help resolve discrepancies, common goals, and timelines.
They anticipate the deadlines and data needed.
Help with continuing reviews and any FDA updates,
professional meeting abstracts. Helps with sponsor audits.
Help review previous publications and reports.
Helps with data tables, charts, or graphs, scan images.
And also, mentor other Research Nurses.
Research nurse coordinators multitasks.
So, here is the day in the life
of a research coordinator that you may see.
You may see them in inpatient rounds.
You see them at the clinic. Follow-ups with participants,
with their principal investigators,
and with sponsors.
Provide phone calls, screening participants,
data management activities,
and assisting with the monitoring and audit visits.
Roles based on different responsibilities
within the research team.
We have the clinical research nurse coordinator
and the research nurse coordinator.
And both helps with clinical practice,
human subjects protection, contribution to the science,
care coordination and continuity of Care,
and study management.
And as you can see, both roles do the same thing
but they have different responsibilities
and the weight of each role may differ.
The protocol coordinator workload may include
protocol development,
such sas assistance with writing and developing new protocols
for new and established investigators,
guiding and mentoring new investigators.
Data entry may assist with entry of current
and historical data, potential for trend analysis,
and potential new information for future studies.
Protocol coordination helps with the screening, recruiting,
CRIS coordination, and providing institutional knowledge.
Regulatory support help with IRB submissions,
including continuing reviews,
initial review of the study and amendments,
and resource for regulatory updates.
In 2018, American Nurses Association,
ANA, recognized clinical research
nursing as a specialty nursing practice.
Our success is determined by the quality of services
we provide to others and to ourselves.
Quality is the result of an excellent work culture,
open and effective communication,
and learning from one another with constructive feedback.
Here are some questions.
Number one, you have to be certified in research
in order to be a research nurse coordinator. False.
You do not have to be certified in research
in order to be a research nurse coordinator.
Number two, research nurses only work at hospitals. False.
Research nurses have a variety of roles
and they do not only work at hospitals.
Number three, research nursing
is not recognized as a sub-specialty?
False. Research nurse is now recognized as a sub-specialty.
Thank you so much for listening. Hope you have a great day.