Protocol Coordinator (Research Nurse)

University of Southern California • Los Angeles, CA

20h • $50 - $63 • Onsite

About The Position

The University of Southern California (USC) is seeking an experienced Registered Nurse with a strong interest in clinical research to join their team as a Protocol Coordinator. This diverse role requires an individual who can work independently while also collaborating effectively with physicians, patients, peers, data managers, and other hospital personnel. The Coordinator is accountable to the Medical Director, Associate Director of CISO, and the Principal Investigator(s) they work with, and must be familiar with and adhere to hospital policies and procedures.

Requirements

• Bachelor’s Degree
• Minimum one year experience
• Current California Registered Nurse license
• Ability to work independently with minimal supervision
• Ability to work well with many people and in different disciplines
• Completes Human Subject Training, HIPPA, GCP, and Sexual Harassment on-line courses.
• Takes Blood Bourne Pathogens class and obtains shipping certificate
• Current CPR certification
• Clinical experience or clinical research experience
• Ability to communicate effectively and professionally with patients and their families, other medical staff and administrative personnel.

Nice To Haves

• Will complete credentialing application and competency course for scribing chemotherapy/biotherapy orders with Norris clinics.

Responsibilities

• Reviews new protocols prior to CIC approval, assessing necessity and feasibility of study tests, treatment and dose modification, and drug toxicities. Provides feedback for budget setup.
• Ensures studies are conducted as written after study start to answer scientific questions.
• Conducts ongoing assessment of protocol deviations and violations.
• Participates in NCI, FDA, and pharmaceutical audits, understanding regulations, especially concerning Serious Adverse Events (SAE) reporting. Enters SAE into iStar and notifies Data Manager.
• Interacts with pharmaceutical company monitors.
• Enters patient registration data into the database and ensures accurate entry of patient response to therapy when 'Off Treatment'.
• Assists Biostatistician with publishing study results upon request.
• Keeps Data Manager updated on patient On Study and Off Treatment/Off Study status.
• Assists in training other Coordinators.
• Determines patient eligibility by scheduling necessary tests.
• Ensures written informed consent is obtained using the correct IRB-approved version, answers patient questions, and manages consent documentation.
• Calculates correct drug doses based on Body Surface Area (BSA) and performs subsequent dose modifications based on toxicity.
• Ensures correct return clinic appointments or hospital admissions and schedules required follow-up tests and procedures.
• Corresponds with outside physicians to ensure protocol adherence and obtains treatment records and outside laboratory results.
• Ensures study toxicities are recorded and graded accurately and follows FDA guidelines for reporting Serious Adverse Events within 24 hours.
• Fills out Violation Reports for any violations that occur.
• Works with the Research Pharmacist to maintain accuracy of drug logs.
• Obtains and transports investigational drugs, and promptly returns unused drugs.
• Ensures patient compliance with oral investigational drugs.
• Arranges admission to the Clinical Trials Unit (CTU) for sample collection.
• For other research blood draws, fills out specimen request slips, coordinates with the clinical lab, processes samples, and stores them appropriately.
• Supervises packing, transporting, and shipping of research samples according to guidelines.
• Ensures Quality of Life questionnaires are completed when appropriate.
• Ensures data needed by the Data Manager to complete CRFs are obtained and documented, and may be responsible for completing some CRFs.
• Follows CISO SOPs.
• Acts as a consultant to the PI in accruing patients and discusses patient eligibility and concerns.
• Serves as a liaison between patient and physician for medical problems.
• Discusses toxicities, protocol deviations, or violations that may require reporting.
• Ensures tumor measurements are obtained, recorded, and tumor responses are calculated properly, and that the physician signs the Tumor Flow Sheet.
• Discusses available study protocols with prospective patients/families over the phone.
• Screens for potential patient protocol entry.
• Coordinates pre-study evaluations and follow-up with patients.
• Assesses psychosocial needs to ensure patient compliance.
• Conducts thorough pre-study assessments for baseline symptoms for the Toxicity Assessment form.
• Sees patients at each visit for ongoing toxicity assessment, ensures physician countersigns the Toxicity Assessment Form, and ensures appropriate dose modification.
• Educates patients about possible toxicities and instructs them to call with questions or problems, triaging calls with the physician.
• Assesses, documents, and manages adverse reactions with the physician.
• Conducts in-service classes for nurses, pharmacists, and CTU personnel for new investigational drugs/protocols.
• Functions as the resource person 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 hospital lab, CTU, and destination lab.
• Coordinates CTU admissions with CTU staff, completes standardized orders, and ensures sponsor-provided lab kits are delivered.
• Works with different disciplines and clinics for patient recruitment and trial conduct.
• Fills Research Order Forms (ROFs) for research visits and submits them to the CRO.
• Complies with hospital regulations and guidelines set by Hospital nursing service.
• Makes arrangements for coverage with peers during absences due to illness, vacation, or meetings.

Benefits

• USC is an equal opportunity employer.
• USC observes affirmative action obligations consistent with state and federal law.
• We provide reasonable accommodations to applicants and employees with disabilities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level