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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