The Clinical Research Coordinator I independently manages clinical study coordination, including patient screening for eligibility, informed consent participation, and data collection. They ensure compliance with federal and local regulations such as FDA and IRB requirements, maintain accurate documentation, and communicate study information to stakeholders. Additionally, they support monitoring activities, regulatory submissions, and maintain confidentiality under HIPAA guidelines.
Job DescriptionThe 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 ResponsibilitiesJob qualifications
clinical research coordinator, study coordination, patient screening, protocol eligibility, informed consent, data collection, FDA compliance, IRB regulations, clinical trials, Good Clinical Practice
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