Protocol Coordinator (Research Nurse)
Company: University of Southern California
Location: Los Angeles
Posted on: February 23, 2021
Due to the Coronavirus (COVID-19) pandemic, we expect delays in
some of our hiring process and will leverage our digital
capabilities to continue recruiting top talent. For more
information on applying to USC during the pandemic please visit our
FAQ page . Keck Medicine of USC is hiring for immediate openings!
Apply now ! USC is a leading private research university located in
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in the region, we offer the opportunity to work in a dynamic and
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talents and skills across a variety of academic schools and units.
As a USC employee, you will enjoy excellent benefits and perks ,
and you will be a member of the Trojan Family - the faculty, staff,
students and alumni who make USC a great place to work. Think
you've got what it takes to join us? We invite you to search our
open positions and apply! Protocol Coordinator (Research
Nurse)Apply Keck School of Medicine Los Angeles, California
This position requires a person who is an experienced Registered
Nurse and has a strong interest in clinical research. The role of
the protocol coordinator is a diverse one. This person works
independently, yet is able to relate well with physicians,
patients, peers, data managers, and other hospital personnel. The
Coordinator is accountable to the Medical Director and Associate
Director of CISO and to the Principal Investigator(s) with whom
he/she works. This person is familiar with and adheres to the
policies and procedures of the hospital where working.Specific Job
A. Protocol Related
1. On request from supervisor, reviews new protocols prior to CIC
(a review committee) approval, looking specifically at necessity
and feasibility of required study tests, at areas pertaining to
treatment and dose modification, and drug toxicities. On request
will provide feedback regarding time or effort to facilitate budget
2. After study start, ensures that study is conducted as written so
that scientific questions are answered.
3. Conducts ongoing assessment of protocol deviations and
violations during patients' time on study.
4. Participates in NCI, FDA and pharmaceutical audits and is
knowledgeable of their regulations, especially concerning the
reporting of Serious Adverse Events. Enters SAE into iStar for
reporting to the IRB and promptly notifies Data Manager of
occurrence of SAE.
5. Interacts with the monitors from the sponsoring pharmaceutical
6. Enters patient registration data into caf-- database. Ensures
that patient response to therapy is entered accurately when 'Off
7. On request, may provide assistance and input to Biostatistician
for publishing study results.
8. Keeps his/her Data Manager updated at all times for On Study and
Off Treatment /Off Study of patients.
9. Assists in training of other Coordinators.B. Protocol
1. Determines patient eligibility
a. Schedules necessary tests.
b. Ensures that written informed consent is obtained using correct
version of the IRB approved and stamped Informed Consent. Answers
patient's questions regarding study and toxicities.
i. Places original consent in the research chart at LAC, (at
Norris gives to the Data Manager to be included with CRFs),
gives a copy to the patient, and sends a copy to CTO (TRUE). CTO
will scan into hospital electronic database.
ii. Fills out protocol specific data management forms, i.e., Study
Parameter Worksheets, Toxicity Assessment forms, etc. to aid in
protocol compliance. Places in the research folders.
c. Calculates correct dose of drug to be administered after
determining the Body Surface Area (BSA). Subsequent dose
modifications based on toxicity may be necessary and require
2. Protocol Compliance
a. Ensures correct return clinic appointment or hospital
b. Schedules required tests and procedures for follow-up.
c. If patient being seen at outside facility, corresponds with
outside physician to ensure that protocol is followed and that
tests and procedures are performed. Obtains treatment records from
hospital or physician and obtains outside laboratory results.
d. Ensures that study toxicities are recorded and graded correctly
and accurately. If Serious Adverse Events are experienced, follows
FDA guidelines for prompt reporting within 24 hours.
e. If a violation occurs, fills out Violation Report in caf--, has
a hard copy signed, and submits to the QA supervisor.
3. --Investigational Drugs
a. Works with the Norris Research Pharmacist in maintaining
accuracy of drug logs.
b. Obtains and transport investigational drugs to LAC/USC Medical
Center from IDS Pharmacy (If LAC patient).
-Promptly returns unused drug from LAC within 24 hours.
c. Ensures patient compliance when taking oral investigational
4. --Pharmacokinetics/blood draws
a. Arranges admission to the Clinical Trials Unit (CTU) at
University Hospital so that samples can be obtained
b. For other research blood draws: At Norris, fills out specimen
request slips and coordinates the drawing of specimens with the
clinical lab, processes samples after blood is drawn, and stores at
the appropriate temperature. At LAC, will also draw the blood
sample, and give to specimen person to process.
c. Supervises packing, transporting and shipping of research
samples to sponsor in accordance with IATA and sponsor shipping
5. Clinical Research Forms (CRFs)
a. When appropriate, ensures that Quality of Life questionnaires
b. Ensures that data needed by the Data Manager to complete CRFs
are obtained and documented.
c. May be responsible for completion of some CRFs
6. Follows CISO SOPs
II. Patient Care Related
A. --Physician/Investigator Interaction
1. Acts as consultant to PI in accruing patients. Discusses patient
eligibility questions and other relevant patient concerns.
2. Is liaison between patient and physician in dealing with medical
3. Discusses toxicities, protocol deviations, or violations that
a protocol violation report or SAE report.
4. Ensure that tumor measurements are obtained, recorded and that
responses are calculated properly. Ensures that physician signs the
Tumor Flow Sheet.B. Patient Interaction
1. Discusses available study protocols over phone when prospective
patients/families call in.
2. Screens for potential patient protocol entry.
3. Coordinates pre-study evaluations and follow up with patients
for any potential questions regarding the study and toxicities.
4. Assesses psychosocial needs to ensure patient compliance.
5. Conducts thorough pre-study assessment for determining baseline
symptoms for Toxicity Assessment form.
6. Sees patient at each visit for ongoing toxicity assessment and
ensures that treating physician countersigns the Toxicity
Assessment Form. When necessary, ensures that the drug dose is
7. Educates patient regarding possible toxicities and instructs
patient to call if any questions or problems. Is the initial
contact person for the patient for problems encountered. Will
triage calls appropriately with the physician.
8. Assesses, documents, and manages adverse reactions with the
physician.C. Hospital Staff Interaction
1. Conducts in-service classes for nurses, pharmacists, and CTU
personnel for new investigational drugs/protocols.
2. Functions as the resource person for protocol study
3. Communicates any patient related problem or concern to staff
nurses, social workers, and home health coordinators.
4. Works closely with pharmacists and hospital nurses to ensure
that protocol agents are administered accurately and safely.
5. Coordinates obtaining, processing, and transporting of research
specimens with hospital lab, CTU and destination lab.
6. If admission to the CTU is required, coordinates each admission
with CTU staff; is responsible for completing standardized orders
and obtaining PI signature. Ensures sponsor provided lab kits are
delivered to CTU.
7. Works with different disciplines, i.e. radiologists, surgeons,
etc., and in different clinics for patient recruitment to studies
and for the conduct of the clinical trial.
8. Fills Research Order Forms (ROFs) for research visit and submits
9. Is familiar with and complies with hospital regulations. Adheres
to guidelines set up by Hospital nursing service. Norris RNs must
apply for credentialing and be approved in order to work in Norris
D. Patient Coverage During Absences From Work
If unable to work due to illness, planned vacation or meetings, the
Protocol Coordinator will make arrangements for coverage with
his/her peers. For Norris, if working in a Program with two
coordinators, the other Coordinator will cover. If working in the
Lung/Head and Neck program or the Women's Program, the Coordinators
from these two Programs will cover each other. At LAC/USC Medical
Center site, the Coordinators cover each other. If unable to
arrange coverage, the coordinator will contact the CISO Associate
Director for assistance.Requirements
I. Current California Registered Nurse license. Will complete
credentialing application and competency course for scribing
chemotherapy/biotherapy orders with Norris clinics.
II. Ability to work independently with minimal supervision
III. Ability to work well with many people and in different
IV. Completes Human Subject Training, HIPPA, GCP, and Sexual
Harassment on- line courses.
V. Takes Blood Bourne Pathogens class and obtains shipping
Minimum Education: Bachelor's degree, Combined experience/education
as substitute for minimum educationMinimum Experience: 1
yearMinimum Field of Expertise: Registered Nurse, California
Registered Nurse license, current CPR certification, and clinical
experience or clinical research experience. Ability to communicate
effectively and professionally with patients and their families,
other medical staff and administrative personnel.
REQ20097247 Posted Date: 02/03/2021 Apply Send jobs to friends
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Keywords: University of Southern California, Los Angeles , Protocol Coordinator (Research Nurse), Healthcare , Los Angeles, California
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