Clinical Research Coordinator I

Job Title: Clinical Research Coordinator I Location: Maywood-Health Sciences Campus, Loyola University Medical Center Work Modality: Hybrid – 4 in-person sessions Job Type: Full-Time FLSA Status: Non-Exempt Position Number: 8151017 Job Summary Under the guidance of the principal investigator and in conjunction with the Clinical Research Nurse, the Clinical Research Coordinator I ensures the integrity and quality of clinical research trials. The Coordinator manages and implements assigned protocols, maintaining efficiency and regulatory compliance across studies conducted at Loyola University Medical Center and satellite sites. Duties and Responsibilities Develop in-depth understanding of each study protocol to 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 and processing of study specimens. Collect and manage patient and laboratory data; maintain research project databases, develop flow sheets and other study‑related documents, and complete case report forms. Assemble study kits for visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact. Participate in monitoring visits and regulatory audits. Perform related duties as assigned. Regulatory Responsibilities Establish and maintain regulatory files for research projects. Maintain ongoing communication with the local IRB, federal organizations, affiliate institutions, and pharmaceutical sponsors. Data Management Responsibilities Collect, record, and maintain accurate data reporting in accordance with protocol and federal guidelines; clarify data queries. Coordinate specimen handling, packaging, and shipping with the Clinical Research RN; manage research sample supplies. Participate in cooperative group audits, FDA, sponsor GCP quality audits, Loyola internal audits, and department audits. Minimum Education and Experience Education: Bachelor’s degree or equivalent training acquired via work experience or education. Experience: Less than one year of previous job‑related experience. Qualifications Ability to analyze and interpret data. Ability to communicate verbally. Ability to compose letters and memorandums. Ability to deal calmly and courteously with people. Ability to finish tasks in a timely manner. Ability to follow oral and written instructions and established procedures. Ability to function independently and manage own time and work tasks. Ability to maintain accuracy and consistency. Ability to maintain confidentiality. Ability to maintain office files and follow standard office procedures. Ability to negotiate, persuade and establish direction. Ability to organize workflow. Ability to perform basic filing, office procedures and word processing. Ability to work as an effective team member. Knowledge of medical terminology. Computer Skills Proficient in Microsoft Office suite; REDcap proficiency preferred. Working Conditions Repetitive motions; irregular hours. EEO Statement Loyola University Chicago adheres to all applicable federal, state, and local civil rights laws and regulations prohibiting discrimination in private institutions of higher education. Please see the University’s Nondiscrimination Policy. #J-18808-Ljbffr