Clinical Research Coordinator V

University of Louisville • Aurora, CO

10d

About The Position

Working under the direction of clinical Principal Investigators in the Department of Surgical Oncology, the Clinical Research Coordinator V coordinates daily activities for multiple clinical research studies, including participant enrollment and accrual, implementation, facilitation, and study operations. The role collaborates with investigators, multidisciplinary clinical entities, sponsors, monitors, and regulatory entities to support participant safety, efficient study operations, and timely study completion. The coordinator is expected to understand how regulatory, financial, and oversight entities work together in clinical research management.

This is a full-time, regular position at the Health Sciences Center. Compensation will be commensurate with candidate experience.

Requirements

• Bachelor's degree in a related field and two or more years of relevant research experience, or an equivalent combination of education and work experience.

Responsibilities

• Coordinate activation, implementation, enrollment, accrual, and maintenance of multiple research protocols.
• Ensure studies are conducted in accordance with University of Louisville Institutional Review Board (UL IRB), Food and Drug Administration (FDA), and Office for Human Research Protections (OHRP) requirements.
• Review regulatory requirements and ensure site compliance with research protocols and appropriate methods, practices, and procedures.
• Assist investigators and clinical staff with identifying, recruiting, screening, and enrolling eligible study participants.
• Develop accurate source materials and ensure site staff compliance.
• Collect, document, enter, and report data accurately and promptly in accordance with site standard operating procedures and applicable regulations.
• Interact with research participants to support eligibility determination and consent.
• Communicate and coordinate study requirements with participants, the research team, multidisciplinary clinical management team, and oversight entities.
• Provide ongoing quality control of study operations, including maintaining accountability logs.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior