Clinical Research Coordinator I - Medical Group

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• The Clinical Research Coordinator I works independently to coordinate studies and screen candidates to determine protocol eligibility.
• They present non-medical trial concepts and details and participate in the informed consent process.
• Ensures source documents, data collection, documentation, entry, and reporting are accurate and completed promptly, including responding to sponsor queries without delay.
• 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 such as the Food and Drug Administration (FDA) and the local Institutional Review Board (IRB).
• Primary

Duties & Responsibilities

Independent study coordination including assessing potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process. Schedules patients for research visits and procedures. In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug. Maintains accurate source documents related to all research procedures. Responsible for accurate and timely gathering, recording, entry, and reporting of data including timely response to sponsor queries. Schedules and participates in monitoring and auditing activities. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings. Notifies direct supervisor about concerns regarding data quality and study conduct. Works 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, and assisting with patient research billing and reconciliation. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board. Maintains research practices using Good Clinical Practice (GCP) guidelines. Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Participates in required training and education programs.