Protocol Coordinator (Research Nurse)

University of Southern California•Los Angeles, CA

2d•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 effectively collaborating 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.

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 the necessity and feasibility of study tests, treatment and dose modifications, and drug toxicities. Provides feedback for budget setup.
Ensures studies are conducted as written after study initiation to answer scientific questions.
Conducts ongoing assessment of protocol deviations and violations during patient study participation.
Participates in NCI, FDA, and pharmaceutical audits, demonstrating knowledge of regulations, especially concerning Serious Adverse Events (SAE) reporting. Enters SAEs into iStar for IRB reporting and notifies the Data Manager promptly.
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'.
May assist Biostatistician with publishing study results upon request.
Keeps 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, and manages consent document distribution.
Fills out protocol-specific data management forms to aid in protocol compliance.
Calculates correct drug doses based on Body Surface Area (BSA) and performs subsequent dose modifications as needed.
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 laboratory results from outside facilities.
Ensures study toxicities are recorded and graded accurately, and follows FDA guidelines for prompt reporting of Serious Adverse Events (within 24 hours).
Fills out and submits Violation Reports if a violation occurs.
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 and stores samples, or draws blood samples and gives them for processing.
Supervises packing, transporting, and shipping of research samples according to 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 regarding patient accrual and eligibility.
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 potential patients for 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 symptom determination.
Performs ongoing toxicity assessments at each visit, ensures physician countersigns the Toxicity Assessment Form, and modifies drug doses as necessary.
Educates patients about possible toxicities and instructs them to call with questions or problems, acting as the initial contact person.
Assesses, documents, and manages adverse reactions with the physician.
Conducts in-service classes for hospital staff on new investigational drugs/protocols.
Functions as a 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 nurses to ensure accurate and safe administration of protocol agents.
Coordinates obtaining, processing, and transporting research specimens.
Coordinates CTU admissions with CTU staff, completes standardized orders, and ensures delivery of sponsor lab kits.
Works with various disciplines and clinics for patient recruitment and trial conduct.
Fills out Research Order Forms (ROFs) for research visits.
Complies with hospital regulations and guidelines set by Hospital nursing service.
Makes arrangements for coverage with peers during absences.
Contacts CISO Associate Director for assistance if unable to arrange coverage.