Senior Clinical Research Coordinator — Trials & Compliance Lead

ULSA University of Louisville; United States; On-site; USD 75,000 - 95,000; Full time

Job summary

The University of Louisville Health Sciences Center, Department of Surgical Oncology, seeks a Clinical Research Coordinator V to oversee enrollment, accrual and daily trial operations. Reporting to the principal investigators, you will coordinate multiple protocols, ensure IRB/FDA/OHRP compliance, and maintain data quality while supporting participants and the research team.

This full-time, salaried position offers growth in a collaborative environment and requires strong regulatory knowledge

Responsibilities

• Coordinates the activation, implementation, enrollment, accrual, and maintenance of multiple research protocols.
• Ensures assigned studies are conducted in accordance with UL IRB, FDA and the OHRP.
• Reviews regulatory requirements to ensure proper methods, practices and procedures.
• Assists investigators and clinical staff in recruitment, screening and enrollment of eligible participants.
• Develops source materials and ensures compliance from site staff.
• Provides accurate data collection, entry and reporting in accordance with site SOPs and applicable regulations.
• Interfacing with research participants to determine eligibility and obtain informed consent.
• Communicates study requirements to the study team and oversight entities (IRB, sponsors, monitors).
• Provides ongoing quality control of study operations including maintenance of accountability logs.

Job description

The University of Louisville Health Sciences Center, Department of Surgical Oncology, seeks a Clinical Research Coordinator V to oversee enrollment, accrual and daily trial operations. Reporting to the principal investigators, you will coordinate multiple protocols, ensure IRB/FDA/OHRP compliance, and maintain data quality while supporting participants and the research team.

This full-time, salaried position offers growth in a collaborative environment and requires strong regulatory knowledge