Senior Protocol Coordinator - Cell Therapy; Research Nurse

Position: Senior Protocol Coordinator - Cell Therapy (Research Nurse)
Job Announcement:

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 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…