This position requires a person who is an experienced Registered Nurse and has an 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. The Coordinator's functions include but are not restricted to those listed below.
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 café 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 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 LAC, (at Norris gives to the Data Manager to be included with CRFs),
gives a copy to the patient, and sends a copy to CTO (TRUE). 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 in café, 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 LAC/USC Medical Center from IDS Pharmacy (If LAC 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 LAC, 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.
5. 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.
Functions as the resource person for protocol study questions.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. Coordinates obtaining, processing, and transporting of research specimens with hospital lab, CTU and destination lab. 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. 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.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.
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 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 LAC/USC Medical Center site, the Coordinators cover each other. If unable to arrange coverage, the coordinator will contact the CISO Associate Director for assistance.
I. 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.
Minimum Education: Bachelor's degree, Combined experience/education as substitute for minimum educationMinimum Experience: 1 yearMinimum 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.