Clinical Research Coordinator I - Guerin Children's Pediatric NICU - Full-Time, Hybrid

Job Description Come join our team! The Clinical Research Coordinator I works independently providing study coordination, screening of potential patients for protocol eligibility, presenting non‑medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting, including timely response to sponsor queries. Responsible for compiling and reporting on each study, including information related to protocol activity, accrual data, workload, and other research information. Presents study information at regular research staff meetings. Ensures compliance with all federal and local agencies, including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB). Primary Duties And Responsibilities Independent study coordination, including screening of potential patients for protocol eligibility, presenting non‑medical trial concepts and details to patients, and participating in the informed consent process. Schedule patients for research visits and procedures. In collaboration with the physician and other medical personnel, document thoroughly on Case Report Forms (CRFs) the following: changes in patient condition, adverse events, concomitant medication use, protocol compliance, and response to study drug. Maintain accurate source documents related to all research procedures. Responsible for accurate and timely data collection, documentation, entry, and reporting, including timely response to sponsor queries. Schedule and participate in monitoring and auditing activities. Compile and report on each study, including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings. Notify direct supervisor about concerns regarding data quality and study conduct. Work closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit adverse events, serious adverse events, protocol deviations, and safety letters in accordance with local and federal guidelines. May perform other regulatory / Institutional Review Board duties, budgeting duties, assist with patient research billing, and reconciliation. Ensure compliance with all federal and local agencies, including the Food and Drug Administration (FDA) and local Institutional Review Board. Maintain research practices using Good Clinical Practice (GCP) guidelines. Maintain strict patient confidentiality according to HIPAA regulations and applicable law. Participate in required training and education programs. Qualifications High School Diploma/GED required. Bachelor's Degree in Science, Sociology, or related degree preferred. One (1) year of clinical research related experience required. SOCRA or ACRP certification preferred upon hire. Prior interventional clinical trial and pediatric NICU clinical research experience is desired. #J-18808-Ljbffr