Clinical Research Coordinator I - Dept of Orthopaedics

What you will be doing in this role Work 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. Provide accurate and timely source documents, data collection, documentation, entry, and reporting, including timely response to sponsor queries. Compile and report on each study including information related to protocol activity, accrual data, workload, and other research information. Present study information at regular research staff meetings. Ensure compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB). Coordinate independent study activities such as patient screening, scheduling research visits and procedures, and collaborative documentation on Case Report Forms (CRFs). Document thoroughly 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. Participate in monitoring and auditing activities and 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, and assist with patient research billing and reconciliation. Ensure compliance with FDA and local IRB regulations and 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 a related degree preferred. One (1) year of clinical research related experience required. #J-18808-Ljbffr