The Clinical Research Associate I supports clinical trials by coordinating study activities, collecting and entering data, and ensuring compliance with protocols and regulations. They assist with regulatory submissions, patient scheduling, and study budgeting while maintaining patient confidentiality and adhering to Good Clinical Practice guidelines. This role requires coordination with research staff and regulatory bodies to facilitate accurate and compliant clinical research.
Job DescriptionPrimary Duties and Responsibilities
The Clinical Research Associate I works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study. Evaluates and abstracts research data and ensures compliance with protocol and research objectives. Responsible for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited patient contact as needed for study and assist with study budget and patient research billing. Ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.
Primary Duties and ResponsibilitiesRequirements:
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Req ID : 11098clinical research, clinical trials, data collection, regulatory compliance, protocol adherence, patient scheduling, case report forms, IRB submissions, HIPAA compliance, Good Clinical Practice
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