Protocol Coordinator

2 weeks ago

Los Angeles, United States USC Full time

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 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 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.

Places original consent in the research chart at LAG, (at

Norris gives to the Data Manager to be included with CRFs),

gives a copy to the patient, and sends a copy to CTO. CTO will scan into hospital electronic database.

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

Ensures correct return clinic appointment or hospital admission. 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, has a hard copy signed, and submits to the QA supervisor.

3. Investigational Drugs

Works with the Norris Research Pharmacist in maintaining accuracy of drug logs. Obtains and transport investigational drugs to LAG Medical Center from IDS Pharmacy (If LAG patient).
- Promptly returns unused drug from LAC within 24 hours.

c. Ensures patient compliance when taking oral investigational drugs

4. Pharmacokinetics/blood draws

Arranges admission to the Clinical Trials Unit (CTU) at University Hospital so that samples can be obtained 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 LAG, 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)

When appropriate, ensures that Quality of Life questionnaires are completed. Ensures that data needed by the Data Manager to complete CRFs are obtained and documented. May be responsible for completion of some CRFs

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