Job Description

Responsibilities: Knowledge of disease process, standard or care, and oncologic terminology Knowledge of study protocol, inclusion and exclusion criteria and amendment training, study endpoints, reportable events (Adverse Event, Serious Adverse Event, Adverse Events of Special Interest) Define methods of subject identification and recruitment Weekly review of study visits completed, Electronic Data Capture (EDC) entries Weekly review of study status Conduct subject recruitment and confirm subject eligibility Assists in recruitment efforts, contacting and identifying potentially eligible participants to screen Coordinate study presentation and Informed Consent Form process with Co-Investigator; obtain consents for amendments where applicable Scheduling and completion of all protocol required study visits and procedures Preparation and maintenance of source documents and review with investigator Maintain Investigational Product dispensing and accountability Review Adverse Events and Serious Adverse Event with Primary Investigator within 24 hour of event report to Institutional Review Board (IRB) and sponsor. Subject retention activities and follow up procedures Protocol monitoring activities, preparation, data clarification Coordination of assessment by investigator of patient, lab results and procedure findings to ensure safe and appropriate enrollment in study and prior to all treatments Vital sign assessments, conduction of ECG, specimen collections, phlebotomy, IV and port insertion, treatment and removal, injections Initiating chemotherapy infusions, maintenance and monitoring of infusion, and observation post infusion Additional duties as assigned

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