Protocol Coordinator (RN)

University of Southern California•Los Angeles, CA

4d•$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 reports to the Medical Director and Associate Director of CISO, as well as the Principal Investigator(s). This position demands familiarity with and adherence to the policies and procedures of the hospital where the work is performed.

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

Nice To Haves

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

Responsibilities

Reviews new protocols, assessing the necessity and feasibility of study tests, treatment and dose modifications, and drug toxicities, providing feedback for budget setup.
Ensures studies are conducted as written after study initiation to answer scientific questions.
Conducts ongoing assessments of protocol deviations and violations during patient study participation.
Participates in NCI, FDA, and pharmaceutical audits, demonstrating knowledge of relevant regulations, especially concerning Serious Adverse Events (SAE) reporting.
Enters SAEs into iStar for IRB reporting and promptly notifies the Data Manager of SAE occurrences.
Interacts with monitors from sponsoring pharmaceutical companies.
Enters patient registration data into the database and ensures accurate entry of patient response to therapy when 'Off Treatment'.
Provides assistance and input to Biostatistician for publishing study results upon request.
Keeps the Data Manager updated on patient status (On Study, Off Treatment/Off Study).
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 regarding the study and toxicities, 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 if patients are seen at outside facilities.
Ensures study toxicities are recorded and graded accurately and follows FDA guidelines for prompt reporting of Serious Adverse Events.
Fills out Violation Reports if a violation occurs and submits them to the QA supervisor.
Works with the Norris 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 pharmacokinetic sample collection.
For other research blood draws, fills out specimen request slips, coordinates with the clinical lab, processes samples, and stores them at the appropriate temperature.
Supervises packing, transporting, and shipping of research samples according to IATA and sponsor guidelines.
Ensures Quality of Life questionnaires are completed and that data needed for CRFs are obtained and documented.
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 the patient and physician regarding 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 potential patients for protocol entry.
Coordinates pre-study evaluations and follow-up with patients, addressing any questions regarding the study and toxicities.
Assesses psychosocial needs to ensure patient compliance.
Conducts thorough pre-study assessments to determine 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 drug dose modification when necessary.
Educates patients about possible toxicities and instructs them to call with any questions or problems, acting as the initial contact person and triaging calls with the physician.
Assesses, documents, and manages adverse reactions with the physician.
Conducts in-service classes for nurses, pharmacists, and CTU personnel regarding new investigational drugs/protocols and serves as a resource person for 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 obtains PI signature.
Ensures sponsor-provided lab kits are delivered to the CTU.
Works with various disciplines and clinics for patient recruitment and trial conduct.
Fills out Research Order Forms (ROFs) for research visits and submits them to the CRO.
Complies with hospital regulations and adheres to guidelines set by Hospital nursing service.
Makes arrangements for peer coverage during absences due to illness, vacation, or meetings, and contacts the CISO Associate Director for assistance if coverage cannot be arranged.