Clinical Research Coordinator I

Responsibilities

• Coordinate clinical research studies from startup through close-out, ensuring adherence to FDA, GCP, and ICH guidelines.
• Serve as the primary contact for research participants, study sponsors, and regulatory agencies.
• Identify potential study participants in collaboration with the PI and RN based on inclusion and exclusion criteria.
• Manage research project databases, collect and maintain accurate patient and laboratory data, and complete case report forms.
• Prepare and process local IRB submissions, including new projects, amendments, adverse events, and study terminations.
• Coordinate the collection, processing, packaging, and shipping of research specimens.
• Maintain essential regulatory files and participate in monitor visits and regulatory audits.
• Monitor study budgets and resolve billing issues in collaboration with finance and management staff.

Requirements

• Bachelor’s Degree or equivalent training acquired via work experience or education.
• Strong project management skills.
• Excellent written and verbal communication skills.

Preferred Qualifications

• Experience working with an oncology population.
• Previous experience in clinical trials is highly desirable.
• CCRA (Certified Clinical Research Associate) or equivalent certification (SoCRA or ACRP).
• Proficiency with EPIC, Microsoft Office Suite, and Clinical Trials Management Systems (CTMS).

About the Company

Founded in 1870, Loyola University Chicago is one of the nation’s largest Jesuit, Catholic universities, recognized for its academic excellence, commitment to community engagement, and leadership in sustainability. As a Carnegie R1 research institution, Loyola leverages its status to advance knowledge that serves communities and creates global impact.