Job Description

Clinical Research Coordinator I Position Title: Clinical Research Coordinator I Position Number: 8151017 Work Modality: Hybrid – 4 In‑Person Job Type: Full‑Time (Non‑Exempt) Campus: Maywood – Health Sciences Department: CBCC Research Job Summary Under the guidance of the principal investigator and in conjunction with the Clinical Research Nurse, the CRC I is responsible for assuring the integrity and quality of clinical research trials, maintaining compliance with good clinical practice (GCP), federal and sponsor regulations, and Loyola University policies. The role involves overall management and implementation of assigned research protocols across Loyola University Medical Center and satellite sites. Duties and Responsibilities Develop in‑depth understanding of each study protocol and ensure adherence to FDA, GCP, and ICH guidelines. Serve as primary contact with research participants, sponsors, and regulatory agencies; coordinate studies from startup through close‑out. Coordinate collection of study specimens and processing. Collect and manage patient and laboratory data; maintain research project databases and develop study documents. Assemble study kits, monitor procedure scheduling and charges, coordinate documentation, and attend monitoring meetings. Participate in monitor visits and regulatory audits. Regulatory Responsibilities Establish and maintain research project regulatory files. Maintain ongoing communication with the local IRB, federal organizations, affiliate institutions, and sponsors. Data Management Responsibilities Collect, record, and maintain accurate data reporting in accordance with protocol and federal guidelines; clarify data queries. Coordinate with the Clinical Research RN to procure, package, and ship research samples; manage supplies. Participate in cooperative group audits, FDA/GCP quality audits, internal audits, and department audits. Minimum Education and Experience Bachelor’s Degree or equivalent training via work experience or education. Less than one year of previous job‑related experience. Qualifications Ability to analyze and interpret data. Strong verbal and written communication skills. Calm, courteous interaction with people. Timely task completion. Follow oral and written instructions and established procedures. Independent time and task management. Accuracy, consistency, and confidentiality. Office filing and standard procedures. Negotiation, persuasion, and direction setting. Workflow organization. Basic filing, office procedures, and word processing. Effective teamwork. Knowledge of medical terminology. Computer Skills Proficient in Microsoft Office suite. REDCap proficiency preferred. Physical Demands Repetitive motions; irregular hours. Equal Employment Opportunity Loyola University Chicago adheres to all applicable federal, state, and local civil rights laws and prohibits discrimination in private institutions of higher education. Please see the University’s Nondiscrimination Policy for details. #J-18808-Ljbffr

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