Clinical Research Coordinator

Clinical Research Coordinator The Clinical Research Coordinator works independently to coordinate clinical research studies, ensuring compliance with all regulatory requirements and facilitating the efficient conduct of research. Responsibilities Screen patients for protocol eligibility and present non‑medical‑trial concepts and details, participating in the informed consent process. Maintain accurate source documents and perform timely data collection, documentation, entry, and reporting, including responses to sponsor queries. Schedule patients for research visits and procedures. Document on Case Report Forms (CRFs) changes in patient condition, adverse events, concomitant medication use, protocol compliance, and response to study drug. Participate in monitoring and auditing activities. Compile and report study data—including protocol activity, accrual data, and workload—to staff meetings. Notify direct supervisor of data quality concerns and study conduct issues. Submit adverse events, serious adverse events, protocol deviations, and safety letters to the Institutional Review Board (IRB) or regulatory coordinator. Assist with patient research billing and reconciliation. Ensure compliance with FDA and IRB regulations and maintain Good Clinical Practice (GCP) guidelines. Maintain patient confidentiality in accordance with HIPAA regulations. Coordinate training and education of other personnel. Participate in centralized activities such as audits and Standard Operating Procedure (SOP) development. Plan and coordinate strategies to increase patient enrollment and improve clinical research efficiency. Identify quality and performance improvement opportunities and develop action plans to enhance research quality. Identify new research opportunities and present them to investigators. Qualifications BA/BS degree (preferred). ACRP/SoCRA (or equivalent) certification preferred. Minimum one year of clinical research coordination experience required. Compensation Pay range: $70,304 to $75,000 per year, depending on experience, certification, education, skills, and location. #J-18808-Ljbffr Astera Cancer Care