Senior Protocol Coordinator - Cell Therapy (Research Nurse)

University of Southern California•Los Angeles, CA

1d•$55 - $73

About The Position

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. This position provides specialized nursing and research support to participants enrolled in cell therapy clinical trials, including CAR T-cell therapy, hematopoietic stem cell transplantation, and other advanced cellular and gene-modified products. 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.

Requirements

Bachelor's degree
2 years Minimum Experience
Clinical research experience and/or demonstrated experience specific to specialty of the study.
Ability to communicate effectively and professionally with patients and their families, other medical staff and administrative staff.

Nice To Haves

3 years in a directly applicable field
current CA RN License

Responsibilities

Contribute to oversight and coordination of activities related to conduct of cell therapy cancer clinical trials; this would include providing guidance and consultation to cell therapy and bone marrow transplant (BMT) team in regard to the needs of cell therapy cancer clinical trials including staffing, infrastructure and other processes
Generate and update protocol specific order sets.
Secure dates with: Inpatient hospital services, BMT lab, Day Hospital, or surgery (depending on cell harvesting method).
Submit insurance authorization.
Determine cell source: Autologous v. Allogeneic to figure out scheduling process
Manage and coordinate operational processes and procedures related to clinical trials involving cell therapy; this would include the creation and maintenance of processes and SOPs to schedule patients, perform research procedures, coordinate with the various involved entities such as hospital, inpatient oncology team, and others
Serve as preceptor for new staff in the team and assists with training, onboarding and continuous education of new employees and existing team members.
Serves as a senior lead in the recruitment, assessment, treatment, data collection and follow-up for patients enrolled in a research study or studies.
Provide guidance to research coordinators to plan, organize and schedule activities to meet research study objectives.
Critiques in-house research studies prior to implementation.
Implements multiple research studies.
Attends start-up meetings for new industry trials off site.
Attends on site study initiation meetings with sponsor and entire research team after IRB approval to discuss protocol and identify potential problems and resolutions.
Provides leadership, guidance, and direction to other health research personnel.
Demonstrates techniques or procedures to others.
Determines patient eligibility for a research study and assesses patients for eligibility for a protocol.
Conducts thorough pre-study assessment to determine baseline toxicities.
Explains study to patients and potential patients.
Answers patient’s questions regarding study, drug toxicities and effectiveness.
Educates patient regarding possible toxicities and instructs patients to call if questions or problems.
Ensures that written informed consent is obtained, readable and that risks are described accurately based on experience.
Completes protocol specific data management forms to aid in protocol compliance.
Reviews research schedules for studies and informs principal investigator if there is concern that a test or the timing is inappropriate.
Schedules required tests and procedures and follows through on completion and return of results.
Corresponds with any outside physicians to ensure protocols are followed and that tests and procedures are performed.
Obtains appropriate treatment records from hospital or physician and obtains outside laboratory results.
Ensures safe administration of investigational drugs.
Works with pharmacists, hospital and BMT nurses to ensure that protocol agents are administered accurately and safely and the maintenance of accurate drug records.
Monitors patient’s status throughout the study.
Reviews and evaluates health status, lab findings and reactions.
Assesses patients for adverse effects of treatment based on knowledge of the patient’s disease and clinical status, which includes recognizing unusual or unexpected side effects that may represent delayed or cumulative toxicity.
Monitors any deviation that may occur and are instrumental in seeing that amendments are made to the study, so that the integrity of the study is not compromised.
Serves as a consultant to the principal investigator.
Discusses patient eligibility questions and any patient concerns.
Notifies physician of serious adverse events.
Discusses toxicities, protocol deviations or violations that may require a protocol revision.
Reviews patient response to therapy.
Informs other health team members regarding patient’s response to treatment and/or medications, adherence to protocol’s schedule, need to reevaluate treatment and specific medical concerns and personal assessment.
Generates data for ongoing evaluation of study, as requested.
Ensures study toxicities are recorded correctly and accurately.
Follows FDA guidelines for prompt reporting.
Communicates serious adverse events to the IRB, government, sponsors, outside agencies and coworkers.
Communicates any patient related problems or concerns to staff nurses, social workers, and home health coordinators.
Develops systems and procedures to complete requirements of the cell therapy trials requiring coordination with the bone marrow transplant (BMT) service.
Resolves inconsistencies in the protocols.
Conveys, implements and interprets policies and procedures.
Makes recommendations regarding procedural matters or departmental improvements.
Performs basic nursing procedures such as phlebotomy, vital signs, and other tests specific to the study.
May administer treatments specific to the study.
Conducts in-service classes for nurses, pharmacists and other personnel for new investigational drugs and protocols.
Assist the team managers and disease-team research coordinators as needed with cell therapy projects
Performs other related duties as assigned or requested.
The university reserves the right to add or change duties at any time.