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 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 an experienced Registered Nurse who is interested in clinical research. The Coordinator works independently while relating well with physicians, patients, peers, data managers, and other hospital personnel. They are accountable to the Medical Director and Associate Director of CISO and to the Principal Investigator(s) with whom they work, and are familiar with and adhere to the policies and procedures of the hospital where they work. Responsibilities Research 1. On request from supervisor, reviews new protocols prior to CIC approval, assessing necessity and feasibility of required study tests, treatment and dose modification, and drug toxicities; may provide feedback on budget set‑up. 2. After study start, ensures that the 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 SAEs into iStar for reporting to the IRB and promptly notifies Data Manager. 5. Interacts with monitors from sponsoring pharmaceutical companies. 6. Enters patient registration data into database; ensures that patient response to therapy is entered accurately when ‘Off Treatment.’ 7. May provide assistance and input to Biostatistician for publishing study results. 8. Keeps Data Manager updated at all times for On Study and Off Treatment/Off Study of patients. 9. Assists in training of other Coordinators. Protocol Administration 1. Determines patient eligibility. a. Schedules necessary tests. b. Ensures that written informed consent is obtained using the correct IRB‑approved version; answers patient questions regarding the study and toxicities; places the original consent in the research chart; provides copies to the patient and to CTO for electronic database entry; fills out protocol‑specific data management forms and places them in research folders. c. Calculates correct drug dose based on Body Surface Area and recalculates for toxicity‑based dose modifications. 2. Protocol compliance: schedules required follow‑up tests and procedures; ensures correct return clinic appointments; corresponds with outside physicians to ensure protocol adherence and captures treatment records and laboratory results; records and grades toxicities accurately; reports Serious Adverse Events within 24 hours; submits violation reports when necessary. 3. Working with the Norris Research Pharmacist to maintain accuracy of drug logs; obtains and transports investigational drugs; returns unused drug promptly. 4. Pharmacokinetics/blood draws: arranges admission to the Clinical Trials Unit; coordinates specimen collection and processing; supervises packing, transporting, and shipping of research samples in accordance with IATA and sponsor guidelines. 5. Clinical Research Forms: ensures quality of life questionnaires are completed; ensures that data needed for CRF completion are obtained and documented; may complete some CRFs. 6. Follows CISO SOPs. Patient Care Related A. Physician/Investigator Interaction 1. Acts as consultant to PI in accruing patients; discusses eligibility and other patient concerns. 2. Acts as liaison between patient and physician regarding medical problems. 3. Discusses toxicities, protocol deviations, or violations that may require a violation report or SAE report. 4. Ensures that tumor measurements are obtained, recorded, and responses are calculated properly; ensures physician signs tumor flow sheet. B. Patient Interaction 1. Discusses available study protocols over the phone for prospective patients/families. 2. Screens for potential patient protocol entry. 3. Coordinates pre‑study evaluations and follow‑up; addresses study and toxicity questions. 4. Assesses psychosocial needs to ensure patient compliance. 5. Conducts thorough pre‑study assessment to determine baseline symptoms for the Toxicity Assessment form. 6. Sees patient at each visit for ongoing toxicity assessment; ensures treating physician countersigns the Toxicity Assessment Form; adjusts drug dose appropriately when necessary. 7. Educates patient about possible toxicities; instructs patient to call for problems; serves as initial contact and triages calls with 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 on new investigational drugs and protocols. 2. Functions as the resource person for protocol study questions. 3. Communicates patient‑related problems to nurses, social workers, and home health coordinators. 4. Works closely with pharmacists and nurses to ensure accurate and safe administration of protocol agents. 5. Coordinates obtaining, processing, and transporting research specimens with hospital lab, CTU, and destination lab. 6. If admission to CTU is required, coordinates each admission, completes standardized orders, and obtains PI signature; ensures sponsor‑provided lab kits are delivered. 7. Works with various disciplines (radiologists, surgeons, etc.) in different clinics for patient recruitment and trial conduct. 8. Fills Research Order Forms for research visits and submits to CRO. 9. Complies with hospital regulations and guidelines set by the nursing service; Norris RNs must obtain credentialing approval 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 arranges coverage with peers or, when necessary, contacts the CISO Associate Director for assistance. Qualifications Bachelor's degree, minimum one‑year of experience; current California Registered Nurse license; competency in scribing chemotherapy/biotherapy orders for Norris clinics; ability to work independently with minimal supervision; strong interpersonal skills; completion of Human Subject Training, HIPAA, GCP, and Sexual Harassment online courses; Bloodborne Pathogens class and shipping certificate; current CPR certification. The hourly rate for this position is $50.13 – $62.89. When extending an offer, USC considers factors such as the scope and responsibilities of the position, the candidate’s work experience, education/training, key skills, internal peer equity, federal, state and local laws, contractual stipulations, grant funding, and external market and organizational considerations. #J-18808-Ljbffr