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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