The Clinical Research Associate I at the Smidt Heart Institute supports the coordination and implementation of cardiovascular clinical studies, ensuring compliance with protocols and regulatory requirements. They handle data abstraction, case report form completion, regulatory submissions, and assist with patient scheduling and billing. This role contributes to advancing cardiac research while maintaining adherence to federal, FDA, IRB, and HIPAA guidelines.
The Smidt Heart Institute reflects Cedars-Sinai's steadfast dedication to heart disease and research innovation giving patients access to the highest level of care. Year after year, thousands of people trust their hearts to Smidt Heart Institute at Cedars-Sinai. Our cardiologists, cardiac surgeons and niche care teams treat the full spectrum of heart disease and disorders, while our investigators continue to advance the field with groundbreaking, life-saving research. From genetic counseling and targeted drug therapies to a growing array of minimally invasive procedures, Cedars-Sinai continues to stand at the forefront of technology, innovation and discovery improving patient outcomes.
Are you ready to be a part of breakthrough research?
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 & Responsibilities:
Education:
Experience and Skills:
clinical research, cardiovascular studies, data abstraction, regulatory compliance, IRB submissions, clinical trial coordination, patient scheduling, research billing, FDA regulations, Good Clinical Practice
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