USC Norris Comprehensive Cancer Center’s Clinical Investigations Support Office (CISO) is seeking a Research Coordinator II to join its team. The position serves as a lead, coordinating aspects of clinical research including study recruitment, scheduling of study-related tests and follow up of enrolled patients. This position requires a person with prior experience as a protocol coordinator. 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 Investigators with whom he/she works. This person is familiar with and adheres to the policies and procedures of the hospital where working. The Coordinator's functions include but are not restricted to those listed below.
Specific Job Functions
I. Research
A. Protocol Related
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. Will provide feedback regarding time or effort to facilitate budget set up.
Serves as a lead assisting with planning and staffing of project operations based on proposed research activities and timelines.
Provides guidance and direction to investigators, study personnel and patients.
Communicates with study team to ensure that study is conducted as written so that scientific questions are answered.
Conducts ongoing assessment of protocol deviations and violations.
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 notifies Data Manager of occurrence of SAE.
Interacts with the monitors/auditors from the sponsoring pharmaceutical companies.
Enters patient registration data into CAFE database. Ensures that patient response to therapy is entered accurately at Off Treatment
Helps generate study results for investigator on request.
Provides assistance and input for publishing study results.
Keeps Data Manager updated at all times for On Study and Off Treatment/Off Study of patients.
Assists with training and demonstrating techniques or procedures to less experience coordinators.
B. Protocol Administration
Determines patient eligibility after patient has been consented
Ensures that written informed consent is obtained using correct version of the IRB approved and stamped and dated Informed Consent. Answers patient’s questions regarding study and toxicities.
Places original consent in the blue 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 database.
Fills out protocol specific data management forms/tools to aid in protocol compliance. Places in the research folders.
Schedules necessary tests.
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.
Protocol Compliance Ensures correct date for return clinic appointment or hospital admission.
Schedules or ensures that required tests and procedures for follow-up are done.
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.
Ensures that study toxicities are recorded correctly and accurately. If Serious Adverse Events are experienced, follows FDA guidelines for prompt reporting within 24 hours.
Investigational Drugs Works with the Research Pharmacist in maintaining accuracy of drug logs.
Obtains and transports…