Protocol Coordinator (Research Nurse)

This position requires an experienced Registered Nurse with a strong interest in clinical research. The coordinator works independently yet collaborates with physicians, patients, peers, data managers, and other hospital personnel. Job Functions Research Protocol Related On request from supervisor, reviews new protocols prior to CIC approval, focusing on necessity, feasibility, treatment, dose modification, and drug toxicities. After study start, ensures study conducted as written to answer scientific questions. Conducts ongoing assessment of protocol deviations and violations during patients’ time on study. Participates in NCI, FDA and pharmaceutical audits, and is knowledgeable of regulations, especially reporting Serious Adverse Events. Enters SAE into iStar for reporting to the IRB and promptly notifies the Data Manager of occurrence. Interacts with monitors from sponsoring pharmaceutical companies. Enters patient registration data into database and records patient response when off treatment accurately. On request may provide assistance to the Biostatistician for publishing study results. Keeps the Data Manager updated at all times for On Study, Off Treatment/Off Study status. Assists in training other coordinators. Protocol Administration Determines patient eligibility, schedules necessary tests. Ensures written informed consent is obtained with correct IRB version; answers patient questions; places original consent in research chart at LAG, gives copy to patient and sends copy to CTO for electronic filing. Fills out protocol‑specific data management forms (Study Parameter Worksheets, Toxicity Assessment forms, etc.) to aid in compliance. Calculates correct drug dose using BSA; recalculates for toxicity‑based dose modifications. Ensures correct return‑clinic appointment or hospital admission; schedules required follow‑up tests. If patient is seen at an outside facility, coordinates with outside physician to ensure protocol followed and obtains treatment records and laboratory results. Records and grades toxicities accurately; follows FDA guidelines for reporting Serious Adverse Events within 24hours. Fills Violation Report when necessary, obtains hard copy signature, and submits to QA supervisor. Works with the Norris Research Pharmacist on investigational drug logs; obtains and transports drugs; returns unused drug promptly. Ensures patient compliance when taking oral investigational drugs. Investigational Drugs Works with the Norris Pharmacy to transport drugs to LAG Medical Center from IDS Pharmacy; returns unused drug from LAC within 24hours. Pharmacokinetics / Blood Draws Arranges admission to the CTU at University Hospital for sample collection. For other research draws, at Norris, fills specimen request slips, coordinates drawing, processes samples, and stores at the appropriate temperature. At LAG draws sample and hands to specimen person for processing. Supervises packing, transporting, and shipping of research samples to the sponsor per IATA and sponsor shipping guidelines. Clinical Research Forms (CRFs) Ensures Quality of Life questionnaires are completed. Collects data needed by the Data Manager to complete CRFs and documents accordingly. May be responsible for completing some CRFs. Patient Care Related Physician / Investigator Interaction Consults PI in accruing patients, discusses eligibility questions and other concerns. Acts as liaison between patient and physician regarding medical problems. Discusses toxicities, protocol deviations or violations that may require reports. Ensures tumor measurements are recorded and responses calculated correctly; ensures physician signs the Tumor Flow Sheet. Patient Interaction Discusses available study protocols over the phone with prospective patients/families. Screen potential patient protocol entry. Coordinates pre‑study evaluations and follow‑up, addressing questions about study and toxicities. Assesses psychosocial needs to ensure compliance. Conducts baseline toxicity assessment, obtaining baseline symptoms. Sees patient at each visit for ongoing toxicity assessment; ensures physician countersigns Toxicity Assessment Form; modifies drug dose appropriately when necessary. Educates patient about possible toxicities and instructs them to call if questions or problems arise; triages calls to physician. Assesses and documents adverse reactions with the physician. Hospital Staff Interaction Conducts in‑service classes for nurses, pharmacists, CTU personnel on new investigational drugs/protocols. Functions as resource for protocol study questions. Communicates patient‑related problems or concerns to staff nurses, social workers, and home‑health coordinators. Works closely with pharmacists and hospital nurses to ensure accurate and safe administration of protocol agents. Coordinates obtaining, processing, and transporting research specimens with the hospital lab, CTU, and destination lab. If CTU admission required, coordinates admission, completes standardized orders, and obtains PI signature. Works with radiologists, surgeons, etc., across clinics for patient recruitment and trial conduct. Fills Research Order Forms (ROFs) for visits and submits to CRO. Familiar with and complies with hospital regulations and nursing service guidelines; Norris RNs must apply for credentialing and be approved to work in Norris Clinic. Patient Coverage During Absences When unavailable due to illness, vacation, or meetings, coordinator arranges coverage with peers or has peers cover; if unable, contacts CISO Associate Director for assistance. Requirements Bachelor’s Degree. Minimum one year of experience. Current California Registered Nurse license. Complete credentialing application and competency course for scribing chemotherapy/biotherapy orders with Norris clinics. State ability to work independently with minimal supervision. State ability to work well with many people across disciplines. Complete Human Subject Training, HIPPA, GCP, and Sexual Harassment online courses. Complete Bloodborne Pathogens class and obtain shipping certificate. Current CPR certification. Clinical experience or clinical research experience. Salary Hourly rate: $50.13 – $62.89. Equal Opportunity Statement USC is an equal‑opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristic protected by law or USC policy. USC observes affirmative action obligations consistent with state and federal law. USC will consider all qualified applicants with criminal records in accordance with applicable laws and regulations, including the LosAngeles County Fair Chance Ordinance and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety. USC provides reasonable accommodations to applicants and employees with disabilities. Applicants with questions about access or requiring a reasonable accommodation for any part of the application or hiring process should contact USC Human Resources by phone at View phone number on click.appcast.io or by email at View email address on click.appcast.io. #J-18808-Ljbffr