Protocol Coordinator (RN)

University of Southern California; Glendale (CA); On-site; USD 68,880 - 86,788; Full time

Job summary

The University of Southern California (USC) seeks an experienced Registered Nurse to join the clinical research team as Protocol Coordinator. The role requires independent work, collaboration with physicians, patients, data managers, and hospital staff, and adherence to hospital policies.

Responsibilities include protocol review, patient eligibility, informed consent, data entry, SAE reporting, and training other coordinators.

Qualifications

• Bachelor's Degree required.
• Current California Registered Nurse license.
• Minimum one year experience in clinical research or related field.
• Ability to work independently and adhere to SOPs.
• Completes required HIPAA, GCP, and safety trainings.

Responsibilities

• Review protocols for feasibility and dosing considerations.
• Ensure study conduct aligns with protocol and regulatory requirements.
• Enter patient data and manage SAE reporting per FDA guidelines.
• Coordinate patient eligibility and informed consent processes.

Skills

Independent worker

Clinical research

Team collaboration

Communication skills

Education

Bachelor's Degree

Job description

About the University of Southern California (USC)

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 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.

Position Overview

This position requires a person who is an experienced Registered Nurse and has a strong interest in clinical research. The role of the protocol coordinator is diverse. The coordinator works independently, yet is able to relate well with physicians, patients, peers, data managers, and other hospital personnel. The coordinator is accountable to the Medical Director, Associate Director of CISO, and to the Principal Investigator(s) with whom they work. The coordinator must be familiar with and adhere to the policies and procedures of the hospital where they work.

Specific Job Functions

1. Research
   1. Protocol Related
      1. On request from supervisor, reviews new protocols before CIC approval, focusing on necessity, feasibility of required study tests, treatment and dose modulation, and drug toxicities; provides feedback on timing or effort to facilitate budget set‑up.
      2. After study start, ensures that the study is conducted as written so that scientific questions are answered.
      3. Conducts ongoing assessment of protocol deviations and violations during a patient’s time on study.
      4. Participates in NCI, FDA and pharmaceutical audits and is knowledgeable of their regulations, especially concerning the reporting of serious adverse events; enters SAE into iStar for reporting to the IRB and promptly notifies the Data Manager of occurrence of SAE.
      5. Interacts with monitors from sponsoring pharmaceutical companies.
      6. Enters patient registration data into the database; ensures that patient response to therapy is entered accurately when “off treatment.”
      7. On request, may provide assistance and input to the biostatistician for publishing study results.
      8. Keeps the Data Manager updated at all times for on‑study and off‑study/or off‑treatment of patients.
      9. Assists in training other coordinators.
   2. Protocol Administration
      1. Determines patient eligibility
         1. Schedules necessary tests.
         2. Ensures that written informed consent is obtained using the correct version of the IRB‑approved and stamped Informed Consent. Answers patient’s questions regarding the study and toxicities; places the original consent in the research chart at LAG (at Norris gives to the Data Manager to be included with CRFs), gives a copy to the patient, and sends a copy to CTO. CTO scans into the hospital electronic database. Fills out protocol‑specific data‑management forms (e.g., Study Parameter Worksheets, Toxicity Assessment forms) to aid in protocol compliance; places them in the research folders.
         3. Calculates the correct dose of drug to be administered after determining the Body Surface Area (BSA). Subsequent dose modifications based on toxicity may require recalculation.
      2. Protocol compliance
         1. Ensures correct return clinic appointment or hospital admission. Schedules required tests and procedures for follow‑up.
         2. If a patient is seen at an outside facility, corresponds with the outside physician to ensure that the protocol is followed and that tests and procedures are performed. Obtains treatment records from the hospital or physician and the outside laboratory results.
         3. Ensures that study toxicities are recorded and graded correctly and accurately. If Serious Adverse Events are experienced, follows FDA guidelines for prompt reporting within 24 hours.
         4. If a violation occurs, fills out a Violation Report, signs a hard copy, and submits to the QA supervisor.
      3. Investigational drugs
         1. Works with the Norris Research Pharmacist to maintain accurate drug logs.
         2. Obtains and transports investigational drugs to LAG Medical Center from IDS Pharmacy (if LAG patient).
         3. Promptly returns unused drug from LAC within 24 hours. Ensures patient compliance with oral investigational drugs.
      4. Pharmacokinetics / blood draws
         1. Arranges admission to the Clinical Trials Unit (CTU) at University Hospital so that samples can be obtained for other research blood draws: At Norris, fills out specimen request slips and coordinates specimen drawing with the clinical lab, processes samples after blood is drawn, and stores them at the appropriate temperature. At LAG, will draw the blood sample and give it to the specimen person to process.
         2. Supervises packing, transporting and shipping of research samples to sponsor in accordance with IATA and sponsor shipping guidelines.
      5. Clinical Research Forms (CRFs)
         1. Ensures that Quality of Life questionnaires are completed when appropriate.
         2. Ensures that data needed by the Data Manager to complete CRFs are obtained and documented.
         3. May be responsible for completion of some CRFs.
      6. Follows CISO SOPs
   3. Patient Care Related
      1. Physician/Investigator Interaction
         1. Acts as consultant to the PI in accruing patients, discussing patient eligibility questions and other relevant patient concerns.
         2. Serves as liaison between patient and physician in dealing with medical problems.
         3. Discusses toxicities, protocol deviations, or violations that may require a protocol violation report or SAE report.
         4. Ensures that tumor measurements are obtained, recorded and that tumor responses are calculated properly; ensures that the physician signs the Tumor Flow Sheet.
      2. Patient Interaction
         1. Discusses available study protocols over phone when prospective patients/families call in.
         2. Screens for potential patient protocol entry.
         3. Coordinates pre‑study evaluations and follow‑up with patients for any potential questions regarding the study and toxicities.
         4. Assesses psychosocial needs to ensure patient compliance.
         5. Conducts a thorough pre‑study assessment for determining baseline symptoms for the Toxicity Assessment form.
         6. Sees patient at each visit for ongoing toxicity assessment and ensures that treating physician countersigns the Toxicity Assessment Form; if necessary, ensures that the drug dose is modified appropriately.
         7. Educates patient about possible toxicities and instructs patient to call if any questions or problems; acts as the initial contact person for patient issues and triages calls appropriately to the physician.
         8. Assesses, documents and manages adverse reactions with the physician.
      3. Hospital Staff Interaction
         1. Conducts in‑service classes for nurses, pharmacists and CTU personnel for new investigational drugs/protocols.
         2. Functions as the resource person for protocol study questions; communicates any patient‑related problem or concern to staff nurses, social workers, and home health coordinators.
         3. Works closely with pharmacists and hospital nurses to ensure that protocol agents are administered accurately and safely.
         4. Coordinates obtaining, processing and transporting of research specimens with hospital lab, CTU and destination lab; if admission to the CTU is required, coordinates each admission with CTU staff and obtains PI signature; ensures sponsor‑provided lab kits are delivered to CTU; works with radiologists, surgeons and other disciplines in different clinics for patient recruitment and conduct of the trial; fills Research Order Forms (ROFs) for the research visit and submits to CRO.
         5. Familiarizes and complies with hospital regulations; adheres to guidelines set up by the Hospital Nursing Service; Norris RNs must apply for credentialing and be approved in order to work in the Norris Clinic.
      4. Patient coverage during absences from work
         1. Ensures coverage with peers during illness, planned vacation or meetings; for the two‑coordinator program the other coordinator covers; for the Lung/Head and Neck program or the Women’s Program coordinators cover each other; at LAG Medical Center the coordinators cover each other. If unable to arrange coverage, the coordinator contacts the CISO Associate Director for assistance.

   Requirements

   • Bachelor's Degree
   • Minimum one year experience
   • Current California Registered Nurse license; will complete credentialing application and competency course for scribing chemotherapy/biotherapy orders with Norris clinics.
   • Ability to work independently with minimal supervision.
   • Ability to work well with many people and in different disciplines.
   • Completes Human Subject Training, HIPAA, GCP, and Sexual Harassment online courses.
   • takes Bloodborne Pathogens class and obtains shipping certificate.

   The hourly range for this position is $50.13 to $62.89. When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidate’s work experience, education/training, key skills, internal peer equity, federal, state and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations.

   Minimum Education and Experience

   Minimum education: Bachelor’s degree, combined experience/education as substitute for minimum education. Minimum experience: 1 year. Minimum field of expertise: RN, eligible for CA licensure, current CPR certification, clinical research experience.