Cleveland Clinic - Las Vegas, NV
posted 2 months ago
Join Cleveland Clinic Neurology, where research and surgery are advanced, technology is leading-edge, patient care is world-class, and caregivers are family. Cleveland Clinic is recognized as one of the top hospitals in the country. In this role, you will coordinate the compliant implementation and conduct of human subject research projects that are typically of medium workload and medium complexity. You will maintain regulatory documents and binders, manage data, and handle IRB submissions and communications. Reporting and completing Serious Adverse Events and/or safety logs as defined per protocol will be part of your responsibilities as they occur. You will also complete Food and Drug Administration (FDA) and sponsor forms in accordance with Good Clinical Practice (GCP) guidelines. Effective communication with sponsors, monitors, and research personnel is essential to ensure all aspects of study compliance. You will serve as a liaison between investigators, research personnel, outside study personnel, and central research administration offices to assist in protocol interpretation, enrollment, and safety questions. Collaboration with the study team will be necessary to schedule pre-site selection visits, site initiation visits, webinars, monitoring, and close-out visits. You will work closely with the primary investigator, sponsor, and research staff to plan, conduct, and evaluate project protocols, including research subject recruitment, while monitoring and reporting project status. Your role will also involve completing regulatory documents, data capture, monitoring plans, and protocol-related activities. You will need to attain and maintain clinical competencies for unlicensed caregivers, such as phlebotomy, vital signs, ECG, POC testing, and other testing as required. Monitoring research data to maintain quality and demonstrating comprehension of assigned research protocols will be crucial. You will assist with preparing audits and responses to audits, develop and maintain research tools, and maintain study personnel certification records. Additionally, you will document the education and training of research personnel as needed and participate in the conduct and documentation of the informed consent process. Lastly, assisting the Principal Investigator (PI) with research study design and developing research protocols will be part of your responsibilities.