A protocol nurse works with an investigative team to develop and implement clinical protocols. They have expertise in their specialty area as well as clinical research. This blend of skills allows them to help develop, implement, and execute clinical protocols while also ensuring patient safety, health, and well-being. Protocol nurses are responsible for collaborating on research tools, assisting with physician orders, monitoring patients, administering medications, and participating in preparing and reviewing research studies.

1. Nursing

2. What is a Protocol Nurse?
The Protocol Nurse works with the
investigative team in developing and
implementing clinical protocols on the GCRC.
Each protocol nurse is experienced in their
area of specialty as well as in clinical
research.
This unique blend of expertise provides the
investigative team with the clinical skill and
expert knowledge needed to develop,
implement and execute clinical protocols.

3. Protocol Nurse (Continued)
To further aid in our clinical expertise, all
GCRC nurses work within clinical cluster
groups such as neurology, psychiatry, neuro-bioimaging,
cardiology, critical care,
endocrinology, infectious disease, pediatrics
and oncology.
In addition, the nurse provides the
compassion and human caring necessary to
ensure the well being of our subjects.

4. Nursing Responsibilities
Development and implementation of the
protocol in collaboration with the study team
and GCRC staff, including:
Collaborates with study team to develop
research data collection tools.
Assist with physician order implementation.
Conducts regular evaluation of protocol
progress with PI, study staff, GCRC staff.
Conducts Nursing assessments.

5. Nursing Responsibilities
(Continued)
Educates GCRC staff on protocol-specific
procedures.
Designs a plan of care that ensures:
subject safety
maintenance of subject’s health state
prompt identification and treatment of
adverse events
Implementation of the discharge plan.

6. Nursing Responsibilities
(Continued)
Monitors subjects’ physiological and
psychological status during the study.
Oversees accuracy of lab slips and
specimen labels.
Administers study medication and
procedures and observes and records
subjects’ response.

7. Nursing Responsibilities
(Continued)
Participates in preparation of study
findings for presentation and
publication.
Participates in research protocol review
with membership on Partners HRC
committees and MGH Patient Care
Services Collaborative Governance
committees.

8. Common Nursing Procedures
Performs clinical assessment of the subject.
Implements emergency preparedness.
Performs venipuncture or IV placement for
administration of medication.
Continually assesses subjects’ response.
Completes EKG and physiological monitoring.
Conducts study-specific procedures and
equipment usage as appropriate.

9. Common Nursing Procedures
(Continued)
Teaches protocol requirements, reviews
study visit, injection teaching, urine
collection, medication administration,
etc.
Processes laboratory samples in the
absence of lab tech staff.
Develop protocol-specific scheduling
templates.

10. Study Staff Requirements
Confirm study visit date and time with the
research subject.
Arrive at the scheduled time.
Submit approved doctors’ orders two
business days before scheduled visit.
Delivers protocol-specific equipment and
supplies, including medications and protocol-specific
aliquots and tubes.
Pick up specimens in a timely fashion.

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