We are seeking an experienced Senior Clinical Research Coordinator to support a busy clinical research team during a 15-week contract assignment. This role is responsible for coordinating all aspects of clinical research studies, ensuring compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines while delivering exceptional patient care.
Responsibilities
Coordinate and manage multiple clinical research studies from start-up through closeout.
Screen, recruit, consent, and schedule study participants.
Collect, document, and maintain accurate study data and source documentation.
Ensure compliance with FDA, IRB, GCP, and sponsor requirements.
Prepare for sponsor visits, monitoring visits, and audits.
Coordinate study procedures, laboratory specimens, and investigational product accountability.
Maintain regulatory binders and study documentation.
Communicate effectively with investigators, sponsors, research staff, and participants.
Assist with data entry, query resolution, and timely reporting of adverse events.
Qualifications
Must have at least 3+ years of Oncology Phase 1 clinical research coordination experience.