Summary

This position provides with day to day activities of clinical trials. Many of these duties will include monitoring of research participants, enrollment, and screening. Responsibilities require flexibility and detail oriented individual to work closely with senior research staff. Performs patient screening, blood draws, plans and schedules study visits, does reporting for IRBS, FDA, and Data Safety Review Committee.

Job Duties

• Coordinates day-to-day activities of research protocols, including screening, enrollment, and monitoring of research participants.
• Ensures accurate data collection, documentation, organization, and the safety of research participants.
• May supervise other research staff.
• Coordinates assignments involving research specialties, clinic staff, and hospital staff to ensure protocol adherence and that studies are conducted in accordance with Good Clinical Practice (GCP) guidelines.
• Maintains daily coordination activities while working to minimize clinic visits and complete study procedures in a manner that does not interfere with routine clinical care.
• Conducts comprehensive assessments of adverse events in collaboration with the participant's physician and other care team members. Assesses, documents, and grades adverse events in accordance with standardized NCI guidelines.
• Reports adverse events to the sponsor, as appropriate. Understands which adverse events may require modifications, such as dose delays, dose modifications, or supportive care, and effectively communicates this information to the treating physician and/or care team.
• Serves as the primary point of contact for clinical trial participants. In collaboration with departmental physicians, assesses whether symptoms may be related to the investigational product, the disease under study, other medications, or a combination of these factors. Obtains appropriate information from participants, determines when escalation is necessary, and evaluates the potential impact on study conduct.
• Performs other job duties as assigned.

Minimum Qualifications

• Bachelor's degree in a related field. Four years of related experience may substitute for degree requirement.
• Two years of relevant experience.

Preferred Qualifications

• Oncology research study experience.
• Spanish speaking.