Protocol Coordinator (Research Nurse)
Location: Los Angeles
Posted on: August 3, 2020
SunIRef:cr006 The Clinical Investigations Support Office (CISO)
at Norris Cancer Center is looking for a Protocol Coordinator
(Research Nurse). The University of Southern California (USC),
founded in 1880, is the largest private employer in the City of Los
Angeles. As an employee of USC, you will be a part of a world-class
research university and a member of the "Trojan Family," which is
comprised of the faculty, students and staff that make the
university what it is. This position requires a person who is an
experienced and licensed 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 Functions I. Research 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 set up. 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 companies. 6. Enters
patient registration data into cafe database. Ensures that patient
response to therapy is entered accurately when 'Off Treatment'. 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
Administration 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 recalculation. 2. Protocol Compliance a.
Ensures correct return clinic appointment or hospital admission. 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 cafe, 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 drugs 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 guidelines. 5. Clinical
Research Forms (CRFs) a. When appropriate, ensures that Quality of
Life questionnaires are completed. 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
problems 3. Discusses toxicities, protocol deviations, or
violations that may require a protocol violation report or SAE
report. 4. Ensure that tumor measurements are obtained, recorded
and that tumor 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 modified
appropriately, 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 questions. 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
to CRO. 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 Clinic. 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 disciplines IV. Completes Human Subject Training, HIPPA,
GCP, and Sexual Harassment on- line courses. V. Takes Blood Bourne
Pathogens class and obtains shipping certificate Job Profile
Summary Minimum Education: Bachelor's degree, Combined
experience/education as substitute for minimum education Minimum
Experience: 1 year Minimum 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.
Keywords: USC, Los Angeles , Protocol Coordinator (Research Nurse), Healthcare , Los Angeles, California
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