Senior Protocol Coordinator - Cell Therapy (Research Nurse)

Cell Therapy Clinical Trials Coordinator

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.

Specific Job Functions
• Contribute to oversight and coordination of activities related to the conduct of cell therapy cancer clinical trials, providing guidance and consultation to the cell therapy and bone marrow transplant (BMT) team regarding staffing, infrastructure and processes.
• Generate and update protocol‐specific order sets; secure dates with inpatient hospital services, BMT lab, day hospital or surgery as appropriate, submit insurance authorization and determine cell source (autologous vs. allogeneic) to plan scheduling.
• Manage and coordinate operational processes and procedures, creating and maintaining SOPs to schedule patients, perform research procedures and coordinate with hospitals, inpatient oncology teams and other entities.
• Serve as preceptor for new staff, assisting with training, onboarding and continuous education of new and existing team members.
• Act as senior lead in recruitment, assessment, treatment, data collection and follow‐up for patients enrolled in research studies; provide guidance to research coordinators, critique in‐house studies prior to implementation and implement multiple studies.
• Attend start‐up meetings for new industry trials off site and on‐site study initiation meetings after IRB approval to discuss protocols and identify potential problems and resolutions.
• Provide leadership, guidance and direction to other health research personnel and demonstrate techniques or procedures to others.
• Determine patient eligibility, conduct thorough pre‐study assessments, explain studies to patients, answer questions about drug toxicities and effectiveness, educate patients about potential toxicities and ensure written informed consent is obtained.
• Review research schedules, inform the principal investigator about concerns, schedule necessary tests and procedures, correspond with outside physicians, obtain treatment records and outside laboratory results.
• Ensure safe administration of investigational drugs by working with pharmacists, hospital and BMT nurses and maintaining accurate drug records.
• Monitor patient status throughout the study, review health status and laboratory findings, assess adverse effects, recognize unexpected side effects, monitor deviations and ensure amendments are made to preserve study integrity.
• Serve as consultant to the principal investigator, discuss patient eligibility and concerns, notify physicians of serious adverse events, discuss toxicities, protocol deviations or violations, review patient response to therapy and generate data for ongoing study evaluation.
• Ensure study toxicities are recorded correctly, follow FDA guidelines for prompt reporting, communicate serious adverse events to the IRB, government, sponsors, outside agencies and coworkers, and communicate patient related problems to staff nurses, social workers and home health coordinators.
• Develop systems and procedures to meet the requirements of cell therapy trials; resolve protocol inconsistencies, convey, implement and interpret policies and procedures and recommend procedural or departmental improvements.
• Perform basic nursing procedures such as phlebotomy, vital signs and other study‐specific tests; may administer study‐specific treatments, conduct in‐service classes for nurses, pharmacists and other personnel for new investigational drugs and protocols.
• Assist team managers and disease‐team research coordinators with cell therapy projects as needed.
• Perform other related duties as assigned; the university reserves the right to add or change duties at any time.

Minimum Education

Bachelor's degree

Minimum Experience

2 years

Minimum Skills
• Clinical research experience and/or demonstrated experience specific to the specialty of the study.
• Ability to communicate effectively and professionally with patients and their families, other medical staff and administrative staff.

Preferred Experience

3 years in a directly applicable field, current CA RN License

Job Summary

Cell therapy clinical trials involve significant complexity and require a high degree of expertise and coordination between the research team and the clinical teams involved in managing the patient, including hematology/BMT, medical oncology for solid tumor trials, and nursing. Further, cell therapy trials are quite heterogeneous with different investigational products that require various approaches and steps to prepare the patient for receipt of the product.

While disease‐team research coordinators are proficient at screening and enrolling patients on clinical trials, they do not have the necessary specialized expertise in coordinating cell therapy trials and in managing patients on such trials.

As USC Norris continues to grow its portfolio of cell therapy trials (both industry‐funded and investigator‐initiated), the dedicated cell therapy senior protocol nurse coordinator will play a critical role in coordinating cell therapy related activities between CISO, the clinical teams and the hospital staff.

The Cell Therapy Research Nurse Coordinator is responsible for delivering protocol‐driven clinical care, performing comprehensive patient assessments, monitoring and managing therapy‐related adverse events, and providing detailed patient and caregiver education. These functions may be performed by the Research Nurse Coordinator directly or in collaboration with other research staff from CISO. The role contributes to the development, coordination, and implementation of cell therapy protocols, while maintaining accurate data collection and documentation in accordance with Good Clinical Practice (GCP), institutional policies, and regulatory standards.

The cell therapy senior protocol nurse coordinator will support the disease teams involved in cell therapy trials by providing education, coordination, and preparing appropriate orders. The coordinator will also interface with the various sponsors (external and internal) and work in close collaboration with the Bone Marrow Transplant (BMT) clinical team and relevant hospital entities. This position partners with multidisciplinary teams, including physicians, advanced practice providers, pharmacists, nursing staff, and research sponsors to ensure appropriate support for cell therapy trials. The role is essential in integrating research objectives with clinical practice to ensure that cell therapy trials are conducted ethically, safely, and effectively to advance scientific knowledge and improve patient outcomes.

Equal Opportunity Employer 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 for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety.

We provide 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 (213) 821-8100, or by email at uschr@usc.edu. Inquiries will be treated as confidential to the extent permitted by law.