Protocol Coordinator (RN)

University of Southern California•Los Angeles, CA

6d•$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) they work with, and must be familiar with and adhere 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
Eligible for CA licensure
Current CPR certification
Clinical research experience

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 required 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 during patient study time.
Participates in NCI, FDA, and pharmaceutical audits, demonstrating knowledge of regulations, especially concerning Serious Adverse Event (SAE) reporting. Enters SAEs into iStar for IRB reporting and notifies 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 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 compliance and obtains treatment records and lab 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 Violation Reports for any violations that occur.
Works with the Norris Research Pharmacist to maintain accuracy of drug logs and obtains/transports investigational drugs.
Returns unused drugs promptly and ensures patient compliance with oral investigational drugs.
Arranges admission to the Clinical Trials Unit (CTU) for sample collection and coordinates blood draws, processing, and storage of research samples.
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 complete 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 and responses are obtained, recorded, and 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 pre-study assessments for baseline symptoms for the Toxicity Assessment form.
Assesses and documents ongoing toxicities, ensures dose modifications are made appropriately, and obtains physician countersignatures.
Educates patients about potential toxicities and instructs them to call with any questions or problems, triaging calls with the physician.
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 with pharmacists and nurses to ensure accurate and safe administration of protocol agents.
Coordinates specimen collection, processing, and transport with various hospital departments and destination labs.
Coordinates admissions to the CTU, completes standardized orders, and obtains PI signatures.
Works with different disciplines and clinics for patient recruitment and clinical trial conduct.
Fills out 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 peer coverage during absences due to illness, vacation, or meetings.