Clinical Research Coordinator V - Trial Operations Leader

University of Louisville; United States; On-site; USD 70,000 - 100,000; Full time

Job summary

The University of Louisville seeks an experienced Clinical Research Coordinator V to oversee enrollment, accrual, and coordination of multiple clinical trials in the Department of Surgical Oncology. You will work with investigators, sponsors, monitors, and regulatory bodies to ensure participant safety and study integrity.

Under the direction of the clinical Principal Investigators, you will manage daily trial activities, ensure regulatory compliance, and facilitate communication across

Qualifications

• Bachelor's degree in a related field and 2+ years of relevant research experience or an equivalent combination of education and work experience.

Responsibilities

• Coordinates the activation, implementation, enrollment, accrual, and maintenance of multiple research protocols.
• Ensures studies are conducted in accordance with UL IRB, FDA and OHRP requirements.
• Reviews regulatory requirements to confirm proper implementation of methods and procedures.
• Assists investigators and staff in identifying, recruiting, screening and enrolling eligible participants.
• Develops accurate source materials and ensures site staff compliance.
• Data collection, documentation, data entry and reporting per site SOPs and regulations.
• Communicates study requirements to participants and the research team to ensure consent and understanding.

Skills

Clinical research coordination

Regulatory compliance

Participant recruitment

Education

Bachelor's degree in a related field

Job description

The University of Louisville seeks an experienced Clinical Research Coordinator V to oversee enrollment, accrual, and coordination of multiple clinical trials in the Department of Surgical Oncology. You will work with investigators, sponsors, monitors, and regulatory bodies to ensure participant safety and study integrity.

Under the direction of the clinical Principal Investigators, you will manage daily trial activities, ensure regulatory compliance, and facilitate communication across