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 for research protocols, including participant screening, enrollment, follow-up, and monitoring.
• Ensures accurate data collection, documentation, organization, and the safety of research participants.
• May supervise and provide guidance to other research staff.
• Coordinates clinical research activities with patient care, collaborating with physicians across multiple specialties, clinic personnel, and hospital staff to ensure protocol adherence and compliance with Good Clinical Practice (GCP) guidelines.
• Works to minimize participant burden and clinic visits while ensuring study procedures are completed efficiently and do not interfere with routine clinical care.
• Conducts comprehensive assessment, documentation, and grading of adverse events in collaboration with physicians and other care team members, following National Cancer Institute (NCI) guidelines and study requirements.
• Reports adverse events to study sponsors, as required, and understands when protocol-directed modifications are needed, including dose delays, dose adjustments, or supportive care interventions.
• Communicates these recommendations effectively to physicians and the care team.
• Serves as the primary point of contact for clinical trial participants and assists in evaluating whether reported symptoms may be related to the investigational product, underlying disease, concomitant medications, or other factors, in collaboration with the study physician.
• Gathers and evaluates participant information, escalates concerns as appropriate, and assesses the potential impact on participant safety and study conduct.
• Balances study requirements with routine clinical care to minimize participant burden and clinic visits.
• Conducts comprehensive assessment of adverse events in collaboration with physicians and other care team members, including assessing, documenting, grading, and reporting adverse events in accordance with National Cancer Institute (NCI) guidelines, protocol requirements, and sponsor requirements.
• Identifies and communicates adverse events requiring protocol-directed interventions, including dose delays, dose modifications, supportive care measures, or other treatment adjustments, to the treating physician and research team.
• Serves as the primary point of contact for clinical trial participants and collaborates with physicians to evaluate whether reported symptoms may be related to the investigational product, underlying disease, concomitant medications, or other contributing factors.
• Obtains and evaluates participant-reported information, determines when concerns should be escalated, and assesses the potential impact on participant safety and study conduct in collaboration with the study team.
• 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.