Clinical Research Assistant - Comprehensive Cancer Center

Position Summary

The Clinical Research Associate (CRA) will support the coordination and execution of clinical research activities within Dr. Brittney Keller-Hamilton’s lab. This role is responsible for ensuring studies are conducted in compliance with regulatory requirements, institutional policies, and study protocols while maintaining high-quality data and participant safety. The CRA will work collaboratively with investigators, study coordinators, regulatory teams, and external partners to support study operations across the lifecycle of clinical trials.

Responsibilities

• Study Coordination & Operations
  • Support day-to-day activities of clinical studies
  • Aid in participant recruitment, screening, enrollment, and retention efforts
  • Coordinate study visits and ensure adherence to protocol schedules
  • Maintain study timelines and proactively identify and address operational challenges
• Regulatory Compliance
  • Ensure compliance with GCP, IRB requirements, FDA regulations, and institutional policies
  • Aid in preparation and submission of IRB applications, amendments, continuing reviews, and study reports
  • Maintain regulatory binders (electronic and/or paper) ensuring documents are current and audit-ready
  • Support internal and external audits and monitoring visits
• Data Management & Quality
  • Collect, enter, and verify study data in electronic data capture (EDC) systems
  • Perform routine data quality checks and resolve queries in a timely manner
  • Ensure accurate and complete source documentation
  • Aid in maintaining study databases and tracking logs
• Collaboration & Communication
  • Serve as a liaison between investigators, participants, sponsors, and study team members
  • Participate in team meetings and provide updates on study progress
• Participant Safety & Experience
  • Ensure participant safety through adherence to protocol and monitoring for adverse events
  • Document and report adverse events and protocol deviations per guidelines
  • Provide education and support to study participants throughout the trial

Qualifications

• Bachelor’s Degree in Public Health or related field, or equivalent combination of education experience required
• Strong organizational skills and attention to detail
• Excellent written and verbal communication skills