Research Coordinator II

University of Southern California; Los Angeles (CA); Vor Ort; USD 48.000 - 57.000; Vollzeit

Zusammenfassung

The University of Southern California's Norris Comprehensive Cancer Center invites applications for a Research Coordinator II to coordinate clinical studies, recruit participants, and schedule tests under the supervision of the Medical Director. You will lead project operations and collaborate with physicians, data managers, and study staff.

Responsibilities include protocol review, data management, SAE reporting, patient consent, and adherence to GCP/HIPAA.

Qualifikationen

• Strong medical background and prior protocol coordinator experience.
• Ability to work independently and with physicians, patients, and study staff.
• Familiar with FDA/IRB regulations and GCP/HIPAA requirements.
• Proficient with MS Office applications and data management tasks.
• Excellent communication and writing skills; detail-oriented and able to multi-task.

Aufgaben

• Lead planning and staffing of project operations based on proposed research activities and timelines.
• Review protocols for feasibility and study tests; ensure adherence to written protocol.
• Ensure informed consent is obtained and documented; manage data entry and CRFs.
• Monitor patient safety; report Serious Adverse Events per FDA guidelines.
• Coordinate specimens/dosing calculations and scheduling tests and follow-ups.

Kenntnisse

Administrative or research experience

Medical terminology knowledge

GCP & HIPAA knowledge

Communication and writing skills

Ausbildung

Bachelor's degree

Tools

MS Office

EDC systems

CTMS

Jobbeschreibung

USC Norris Comprehensive Cancer Center’s Clinical Investigations Support Office (CISO) is seeking a Research Coordinator II to join its team. The position serves as a lead, coordinating aspects of clinical research including study recruitment, scheduling of study-related tests and follow up of enrolled patients. This position requires a person with prior experience as a protocol coordinator. 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 Investigators 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.

Specific Job Functions I.

A. Protocol Related

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. Will provide feedback regarding time or effort to facilitate budget set up. Serves as a lead assisting with planning and staffing of project operations based on proposed research activities and timelines. Provides guidance and direction to investigators, study personnel and patients. Communicates with study team to ensure that study is conducted as written so that scientific questions are answered. Conducts ongoing assessment of protocol deviations and violations.

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 notifies Data Manager of occurrence of SAE. Interacts with the monitors/auditors from the sponsoring pharmaceutical companies. Enters patient registration data into CAFE database. Ensures that patient response to therapy is entered accurately at Off Treatment Helps generate study results for investigator on request. Provides assistance and input for publishing study results. Keeps Data Manager updated at all times for On Study and Off Treatment/Off Study of patients. Assists with training and demonstrating techniques or procedures to less experience coordinators.

B. Protocol Administration

Determines patient eligibility after patient has been consented. Ensures that written informed consent is obtained using correct version of the IRB approved and stamped and dated Informed Consent. Answers patient’s questions regarding study and toxicities. Places original consent in the blue 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 database. Fills out protocol specific data management forms/tools to aid in protocol compliance. Places in the research folders. Schedules necessary tests. 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.

Protocol Compliance

Ensures correct date for return clinic appointment or hospital admission. Schedules or ensures that required tests and procedures for follow-up are done. 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. Ensures that study toxicities are recorded correctly and accurately. If Serious Adverse Events are experienced, follows FDA guidelines for prompt reporting within 24 hours.

Investigational Drugs

Works with the Research Pharmacist in maintaining accuracy of drug logs. Obtains and transports investigational drugs to LAC General Medical Center from Research Pharmacy (If LAC patient) and promptly returns unused drug from LAC within 24 hours. Follows CISO SOP for return and accountability of oral drugs.

Pharmacokinetics/blood draws

When necessary, arranges admission to the Clinical Trials Unit (CTU) at Norris Hospital so that multiple samples can be obtained. For other non CTU research blood draws: At Norris, fills out specimen request slips and coordinates drawing of samples with the clinical lab, processes samples after blood is drawn, and stores at appropriate temperature. At LAC, ensures samples are collected and processed by specimen person. Ensures or supervises packing, transporting and shipping of research samples to sponsor in accordance with IATA and sponsor shipping guidelines.

Clinical Research Forms (CRFs)

When appropriate, ensures that Quality of Life questionnaires are completed. Ensures that data needed to complete CRFs are obtained and documented (source documents) for Data Manager. May be responsible for completion of some CRFs for some studies. Follows CISO SOPs.

Patient Care Related

Physician/Investigator Interaction Discusses patient eligibility questions and any patient concerns. Is liaison between patient and physician in dealing with medical problems. Notifies physician of Serious Adverse Event. Keep physician updated on patient problems. Discusses toxicities, protocol deviations, or violations that may require a protocol revision. Ensures that tumor measurements are obtained and calculates responses. Ensures that physician signs the Tumor Flow Sheet.

Patient Interaction

On request, screens for potential protocol patients. Coordinates pre-study evaluations and determines final eligibility to trial. Follows up with patients for any potential questions regarding the study and toxicities. Assesses psychosocial needs to ensure patient compliance. Conducts thorough pre-study assessment for determining baseline symptoms for Toxicity Assessment form. 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. Sees patient at each visit for ongoing toxicity assessment; assesses, documents, and reports adverse reactions and ensures that treating physician agrees and countersigns the Toxicity Assessment Form. If necessary, ensures that the drug dose is modified appropriately.

Hospital Staff Interaction

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. Works closely with pharmacists and hospital nurses to ensure that protocol agents are administered accurately and safely. Coordinates obtaining, processing, and transporting 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. Is familiar with and complies with hospital regulations. Adheres to guidelines set up by hospital. Completes Research Order Form (ROF) after each visit for billing.

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 General Medical Center site, the Coordinators cover each other. When unable to arrange coverage, the coordinator will contact the CISO Associate Director for assistance.

Requirements

Strong medical background, foreign medical graduate desirable. Prior experience as Protocol Coordinator in clinical oncology research. 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 online and obtains shipping certificate. Performs other related duties as assigned or requested.

The hourly rate range for this position is $34.86 - $41.56.

Minimum Education: Bachelor's degree

Minimum Experience: 2 years

Minimum Skills: Administrative or research experience. Knowledge of medical environment and terminology. Knowledge and understanding of federal, state, and institutional research regulations as well as Good Clinical Practices (GCP) and HIPPA regulations. Proficient with MS Office applications. Demonstrated effective communication and writing skills. Ability to multi-task. Demonstrated ability to work as part of a team as well as independently.

Preferred Experience: 3 years

Preferred Skills: Staff education and orientation experience. Knowledge of Electronic Data Capture (EDC) systems and Clinical Trial Management Systems (CTMS).

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