Clinical Research Associate I - Heart Institute - Makkar Team

About the Organization

Cedars-Sinai Medical Center has been named to the Honor Roll in U.S. News & World Report’s “Best Hospitals 2025-2026” rankings. When you join our team, you’ll have access to groundbreaking biomedical research facilities and world-class medical education programs. We take pride in hiring exceptional, dedicated professionals who are passionate about advancing healthcare. Our physicians, nurses, and staff reflect the culturally and ethnically diverse communities we serve and are united by a shared commitment to excellence. Together, we foster a dynamic, inclusive environment that drives innovation and supports the gold standard of patient care.

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. 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.

Responsibilities

• 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.
• Completes case report forms, enters clinical research data, and assists with regulatory submissions to the IRB.
• Provides limited patient contact as needed for study and assists 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.
• Evaluates and abstracts clinical research data from source documents.
• Ensures compliance with protocol and overall clinical research objectives.
• Completes Case Report Forms (CRFs).
• Enters clinical research data into Electronic Data Systems (EDCs) provided by sponsors.
• Provides supervised patient contact or patient contact for long-term follow-up patients only.
• Assists with regulatory submissions to the Institutional Review Board (IRB), including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
• Assists with clinical trial budgets.
• Assists with patient research billing.
• Schedules patients for research visits and research procedures.
• Responsible for sample preparation and shipping, and maintenance of study supplies and kits.
• 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.

Requirements

Education: High School Diploma is required. Bachelor's degree is preferred in Science, Sociology, or a related field.

Experience and Skills: One (1) year of clinical research-related experience is preferred.