The Protocol Coordinator manages clinical research trials by ensuring protocol compliance, coordinating patient eligibility, and monitoring adverse events. They act as a primary liaison between patients, physicians, and pharmaceutical sponsors to facilitate safe and accurate study execution.
Requirements summary
Candidates must hold a Bachelor's degree and a current California Registered Nurse license with at least one year of experience. Proficiency in clinical research, CPR certification, and the ability to work independently across various medical disciplines are required.
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 a 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.
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 a diverse one.
This person 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 and Associate Director of CISO and to the Principal Investigator(s) with whom he/she works.
This person is familiar with and adheres to the policies and procedures of the hospital where working.
Specific Job Functions I.
Research A.
Protocol Related 1.
On request from supervisor, reviews new protocols prior to CIC (a review committee) approval, looking specifically at necessity and feasibility of required study tests, at areas pertaining to treatment and dose modification, and drug toxicities.
On request will provide feedback regarding time or effort to facilitate budget set up.
2.
After study start, ensures that study is conducted as written so that scientific questions are answered.
3.
Conducts ongoing assessment of protocol deviations and violations during patients’ 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 Data Manager of occurrence of SAE.
5.
Interacts with the monitors from the sponsoring pharmaceutical companies.
6.
Enters patient registration data into database.
Ensures that patient response to therapy is entered accurately when ‘Off Treatment’.
7.
On request, may provide assistance and input to Biostatistician for publishing study results.
8.
Keeps his/her Data Manager updated at all times for On Study and Off Treatment /Off Study of patients.
9.
Assists in training of other Coordinators.
B.
Protocol Administration 1.
Determines patient eligibility a.
Schedules necessary tests. b.
Ensures that written informed consent is obtained using correct version of the IRB approved and stamped Informed Consent.
Answers patient’s questions regarding study and toxicities.
Places 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 will scan into hospital electronic database.Fills out protocol specific data management forms, i.e., Study Parameter Worksheets, Toxicity Assessment forms, etc. to aid in protocol compliance.
Places in the research folders. c.
Calculates correct dose of drug to be administered after determining the Body Surface Area (BSA).
Subsequent dose modifications based on toxicity may be necessary and require recalculation.
2.
Protocol Compliance.
Ensures correct return clinic appointment or hospital admission.
Schedules required tests and procedures for follow-up. c.
If patient being seen at outside facility, corresponds with outside physician to ensure that protocol is followed and that tests and procedures are performed.
Obtains treatment records from hospital or physician and obtains outside laboratory results. d.
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. e.
If a violation occurs, fills out Violation Report, has a hard copy signed, and submits to the QA supervisor.
3.
Investigational Drugs Works with the Norris Research Pharmacist in maintaining accuracy of drug logs.
Obtains and transport investigational drugs to LAG Medical Center from IDS Pharmacy (If LAG patient).
Promptly returns unused drug from LAC within 24 hours. c.
Ensures patient compliance when taking oral investigational drugs 4.
Pharmacokinetics/blood draws 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 the drawing of specimens with the clinical lab, processes samples after blood is drawn, and stores at the appropriate temperature.
At LAG, will also draw the blood sample, and give to specimen person to process. c.
Supervises packing, transporting and shipping of research samples to sponsor in accordance with IATA and sponsor shipping guidelines.
5.
Clinical Research Forms (CRFs) When appropriate, ensures that Quality of Life questionnaires are completed.
Ensures that data needed by the Data Manager to complete CRFs are obtained and documented.
May be responsible for completion of some CRFs 6.
Follows CISO SOPs II.
Patient Care Related A.
Physician/Investigator Interaction 1.
Acts as consultant to PI in accruing patients.
Discusses patient eligibility questions and other relevant patient concerns.
2.
Is 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.
Ensure that tumor measurements are obtained, recorded and that tumor responses are calculated properly.
Ensures that physician signs the Tumor Flow Sheet.
B.
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 thorough pre-study assessment for determining baseline symptoms for Toxicity Assessment form.
6.
Sees patient at each visit for ongoing toxicity assessment and ensures that treating physician countersigns the Toxicity Assessment Form.
When necessary, ensures that the drug dose is modified appropriately, 7.
Educates patient regarding possible toxicities and instructs patient to call if any questions or problems.
Is the initial contact person for the patient for problems encountered.
Will triage calls appropriately with the physician.
8.
Assesses, documents, and manages adverse reactions with the physician.
C.
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.
3.
Communicates any patient related problem or concern to staff nurses, social workers, and home health coordinators.
4.
Works closely with pharmacists and hospital nurses to ensure that protocol agents are administered accurately and safely.
5.
Coordinates obtaining, processing, and transporting of research specimens with hospital lab, CTU and destination lab.
6.
If admission to the CTU is required, coordinates each admission with CTU staff; is responsible for completing standardized orders and obtaining PI signature.
Ensures sponsor provided lab kits are delivered to CTU.
7.
Works with different disciplines, i.e. radiologists, surgeons, etc., and in different clinics for patient recruitment to studies and for the conduct of the clinical trial.
8.
Fills Research Order Forms (ROFs) for research visit and submits to CRO.
9.
Is familiar with and complies with hospital regulations.
Adheres to guidelines set up by Hospital nursing service.
Norris RNs must apply for credentialing and be approved in order to work in Norris Clinic.
D.
Patient Coverage During Absences From Work If unable to work due to illness, planned vacation or meetings, the Protocol Coordinator will make arrangements for coverage with his/her peers.
For Norris, if working in a Program with two coordinators, the other Coordinator will cover.
If working in the Lung/Head and Neck program or the Women’s Program, the Coordinators from these two Programs will cover each other.
At LAG Medical Center site, the Coordinators cover each other.
If unable to arrange coverage, the coordinator will contact 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, HIPPA, GCP, and Sexual Harassment on- line courses.Takes Blood Bourne Pathogens class and obtains shipping certificate The hourly rate for this position is $50.13 - $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: Bachelor's degree, Combined experience/education as substitute for minimum education Minimum Experience: 1 year Minimum Field of Expertise: Registered Nurse, California Registered Nurse license, current CPR certification, and clinical experience or clinical research experience.
Ability to communicate effectively and professionally with patients and their families, other medical staff and administrative personnel.
USC is an equal opportunity employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristic protected by law or USC policy.
USC observes affirmative action obligations consistent with state and federal law.
USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety.
Please refer to the Background Screening Policy Appendix D for specific employment screen implications for the position for which you are applying.
We provide reasonable accommodations to applicants and employees with disabilities.
Applicants with questions about access or requiring a reasonable accommodation for any part of the application or hiring process should contact USC Human Resources by phone at (213) 821-8100, or by email at uschr@usc.edu.
Inquiries will be treated as confidential to the extent permitted by law.
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As the largest private employer in the city – responsible for more than $5 billion annually in economic activity in the region – we offer the opportunity to work in a dynamic and diverse environment, in careers that span a broad spectrum of talents and skills.
As a USC employee, you will enjoy excellent benefits and perks, and you will be a member of the Trojan Family - the faculty, staff, students and alumni who make USC a great place to work.
Application help If you need assistance during the application process, see our application help. (If you already work for USC, see Your USC career.) At any point you may also contact our HR Service Center for help at (213) 821-8100 or uschr@usc.edu.
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