Clinical Research Coordinator I (IITs)

Clinical Research Coordinator I (IITs) Full‑time, non‑exempt position located at Loyola University Chicago, Maywood‑Health Sciences Campus. Work is fully in‑person. The role is approved for grant funding and requires coordination of clinical research studies in the Radiation Oncology department. Duties and Responsibilities Develop an 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 the primary contact with research participants, sponsors, and regulatory agencies, coordinating studies from start‑up through close‑out. Collaborate with the PI and RN to identify potential study participants according to inclusion and exclusion criteria using clinical judgment and protocol knowledge. Coordinate collection and processing of study specimens. Collect and manage patient and laboratory data for clinical research projects; manage research project databases, develop flow sheets and other study documents, and complete case report forms. Ensure compliance with research protocols 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. Maintain 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 and federal guidelines; clarify data queries. Coordinate with the Clinical Research RN to procure, 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 Work Experience Bachelor’s Degree or equivalent training acquired via work experience or education. Preferred Qualifications Experience with oncology populations. Project management skills. Excellent written and verbal communication skills. Experience working in clinical trials highly desirable. Certificates / Credentials / Licenses Certified Clinical Research Associate (CCRA) 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 experience. Electronic data entry, web‑based databases. EEO Statement Loyola adheres to all applicable federal, state, and local civil rights laws and regulations prohibiting discrimination in private institutions of higher education. This position is open to qualified individuals regardless of race, color, religion, sex, national origin, disability, veteran status, or any other protected class. #J-18808-Ljbffr LRES Corporation