Protocol Coordinator (RN)

University of Southern California • Los Angeles, CA

3d • $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 effectively collaborating with physicians, patients, peers, data managers, and other hospital personnel. The Coordinator is accountable 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 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
• 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 for necessity and feasibility of study tests, treatment and dose modification, and drug toxicities, providing 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, understanding relevant regulations, especially for Serious Adverse Events (SAE) reporting.
• Enters SAEs into iStar for IRB reporting and notifies Data Manager promptly.
• Interacts with pharmaceutical company monitors.
• Enters patient registration data into the database and ensures accurate entry of patient response to therapy.
• Assists 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, schedules necessary tests, and ensures written informed consent is obtained and properly documented.
• Answers patient questions regarding study and toxicities.
• 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 compliance and obtains treatment records and outside laboratory results.
• Ensures study toxicities are recorded and graded accurately and follows FDA guidelines for prompt reporting of Serious Adverse Events.
• Fills out Violation Reports for any protocol violations.
• Works with the Norris Research Pharmacist to maintain accuracy of drug logs.
• Obtains and transports investigational drugs.
• Ensures patient compliance with oral investigational drugs.
• Arranges admission to the Clinical Trials Unit (CTU) for sample collection and coordinates blood draws, sample processing, and storage for research samples.
• Supervises packing, transporting, and shipping of research samples according to guidelines.
• Ensures Quality of Life questionnaires are completed and that data needed for CRFs is 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 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.
• Discusses available study protocols with prospective patients/families.
• 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 symptoms.
• 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 of research specimens.
• Coordinates CTU admissions and completes standardized orders.
• Ensures sponsor-provided lab kits are delivered to CTU.
• Works with various disciplines and clinics for patient recruitment and trial conduct.
• Fills Research Order Forms (ROFs) for research visits.
• Makes arrangements for patient coverage during absences due to illness, vacation, or meetings.

Benefits

• USC considers factors such as scope and responsibilities of the position, 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 when extending an offer of employment.

What This Job Offers

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