Clinical Research Coordinator I (IITs)

Position Details Title: CLINICAL RESEARCH COORDINATOR I Position Number: 8150814 Work Modality: Fully In-Person New Position? No Job Category: University Staff Job Type: Full-Time FLSA Status: Non-Exempt Campus: Maywood-Health Sciences Campus Department: RADIATION ONCOLOGY Location Code: RADIATION ONCOLOGY (06720A) Grant Funded: Yes Open Date: 04/27/2026 Duties and Responsibilities Coordination responsibilities: Develops in-depth understanding of each study protocol to ensure all aspects of the protocol are adhered to in accordance with FDA, GCP, and ICH Guidelines. Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out. In collaboration with the PI & RN, incorporate clinical judgment and knowledge of protocol to identify potential study participants according to inclusion and exclusion criteria. Coordinate collection of study specimens and processing. Collect and manage patient and laboratory data for clinical research projects. Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms. Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions and ensure institutional Review Board renewals are completed. Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact. Ensure adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff. Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct. Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements. Participate in monitor visits and regulatory audits. Process local IRB submissions to include new research projects, amendments, adverse events, and study terminations. Perform other duties as assigned. Regulatory responsibilities: Establish and maintain research project's regulatory files. Ongoing communication with the local IRB, federal organizations, affiliate institutions, and pharmaceutical study sponsors. Data Management Responsibilities: Collect, record, and maintain accurate data reporting adhering to protocol data collection protocols and federal guidelines. Clarify data queries. Specimen Handling and Shipping Responsibilities: Coordinate with the Clinical Research RN to organize procurement of research samples and then prepare, package, and ship research samples. Manage research sample supplies. Participate in Cooperative Group Audits, FDA, Sponsor GCP quality audits, Loyola internal audits, and department audits. Perform related duties as assigned. Minimum Education and/or Work Experience Bachelor's Degree OR equivalent training acquired via work experience or education. Qualifications Experience with oncology population preferred. Project management skills. Excellent written and verbal communication skills. Experience working in clinical trials highly desirable. Certificates/Credentials/Licenses CCRA (Certified Clinical Research Associate) or equivalent (SoCRA or ACRP) is desired. Computer Skills Proficiency with Microsoft Word, Groupwise, EPIC, Microsoft Excel, Basic Keyboarding Skills, Adobe Acrobat, Beacon. Clinical Trials Management System. Electronic data entry web based databases. Supervisory Responsibilities No Required operation of university owned vehicles No Direct animal or patient contact Yes Physical Demands None Working Conditions None Salary Maximum: $31.25/hr. Minimum: $22.60/hr. Legal/EEO Statement Loyola adheres to all applicable federal, state, and/or local civil rights laws and regulations prohibiting discrimination in private institutions of higher education. Please see the University's Nondiscrimination Policy. #J-18808-Ljbffr Loyola University Chicago