Protocol Coordinator; RN

The University of Southern California (USC) seeks a Protocol Coordinator who is an experienced Registered Nurse with a strong interest in clinical research. The Coordinator will work independently, collaborating closely with physicians, patients, data managers, and hospital staff to ensure protocol compliance and the integrity of each study.

• Protocol Review and Planning
  :
  Review new protocols prior to CIC approval, assess feasibility, provide feedback on timelines and budget setup.
• Study Execution
  :
  Ensure studies are conducted according to protocol, manage protocol deviations and violations, and coordinate monitoring visits by sponsors.
• Adverse Event Management
  :
  Enter serious adverse events (SAEs) into iStar, report to IRB promptly, and notify Data Manager of SAE occurrences.
• Patient Eligibility & Consent
  :
  Determine eligibility, schedule required tests, obtain written informed consent, and maintain all documentation in the research chart.
• Dose Calculation & Administration
  :
  Calculate drug doses using Body Surface Area, adjust doses based on toxicity, and ensure accurate record‐keeping of oral investigational drugs.
• Data Management
  :
  Enter patient registration data and off‑treatment responses into the database, update Data Manager on patient status, and assist the Biostatistician with study results.
• Compliance & Audits
  :
  Participate in NCI, FDA, and sponsor audits, maintain accurate toxicity grading, and comply with FDA SAE reporting guidelines.
• Sample Handling
  :
  Coordinate collection, processing, and shipping of research samples, supervise packing and transport to sponsors following IATA and sponsor guidelines.
• Clinical Research Forms (CRFs):
  Ensure Quality of Life questionnaires and other protocol‑specific forms are completed accurately; assist in CRF completion when required.
• Physician & Patient Interaction
  :
  Act as consultant to PIs regarding patient accrual, serve as liaison for medical issues, discuss toxicities, and maintain tumor measurement data.
• Patient Education & Support
  :
  Conduct pre‑study assessments, educate patients on potential toxicities, triage patient calls, and manage adverse reactions with the physician.
• Hospital Staff Coordination
  :
  Conduct in‑service training for nurses, pharmacists, and CTU personnel; coordinate specimen handling with lab and CTU; fill research order forms and submit to CRO.
• Coverage & Peers Coordination
  :
  Arrange for coverage during absences (illness, vacation, meetings) with peers or the CISO Associate Director as needed.

• Bachelor’s degree and at least one year of clinical experience.
• Current California Registered Nurse license; will complete credentialing and competency course for scribing chemotherapy/biotherapy orders.
• Ability to work independently with minimal supervision and collaborate effectively with multidisciplinary teams.
• Completed Human Subjects Training, HIPAA, GCP, and Sexual Harassment online courses.
• Bloodborne Pathogens class completion and shipping certificate obtained.
• CPR certification; clinical research experience preferred.

Hourly range: $50.13 to $62.89.

USC is an equal opportunity employer. All qualified applicants 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 for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations.

USC provides reasonable accommodations to applicants and employees with disabilities.