Clinical Research Associate II - Heart Institute - Makkar Team

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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.

Are you ready to be a part of breakthrough research?

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.

The Smidt Heart Institute at Cedars-Sinai is looking for a Clinical Research Associate II to join the laboratory of Dr. Raj Makkar.

Raj Makkar, MD is a world-renowned leading expert in interventional cardiology and is one of the most widely cited researchers on the management of valvular heart disease. He has performed the greatest number of transcatheter valve implantation (TAVI) procedures in the world and has led the field in advancing the procedure to ensure the best outcomes for patients. In 2020, he performed the most transcatheter mitral valve repair procedures with the MitraClip system in the United States and is the national principal investigator for mitral valve replacement research studies. He has authored over 500 manuscripts, abstracts and book chapters in peer-reviewed literature including practice-changing contributions in the New England Journal of Medicine and the Lancet. He has lectured extensively around the world and regularly performs live case transmissions for major international conferences to demonstrate cutting-edge interventional cardiology techniques to a world-wide audience. His research interests focus on novel transcatheter therapies to treat structural heart disease, with a focus on studies that directly demonstrate improvements in patient outcomes. Since 2010, he has been the Stephen R. Corday Chair in Interventional Cardiology at Cedars-Sinai and has led the clinical program and trained over 50 fellows both from within the United States and internationally.

The Clinical Research Associate II works independently but in close collaboration with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, other supervising staff to coordinate and/or implement increasingly complex research studies. Supports objectives of research studies through noncomplex tasks such as data collection, prescreening of potential and scheduling of current research participants, assisting in IRB submission activities, budget and billing, and ensuring overall compliance with all federal and local guidelines. Provides increasingly complex and independent support for studies by serving as the independent contact with sponsors, IRB, and research participants, providing training, education to junior level staff, and coordination of ad hoc activities related to studies. May serve independently as study coordinator for minimal number of noncomplex research studies or projects.

Primary Job Duties and Responsibilities:

• Works independently under minimal direction from a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to coordinate and/or implement increasingly complex research studies.
• Collects, evaluates and/or abstracts clinical research data. May assist in designing forms for data collection/abstraction. Enters and processes clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
• Completes Case Report Forms (CRFs).
• Independently prescreens potential research participants for various clinical trials. Schedules research participants for research visits and research procedures. May provide increasingly independent contact with research participants and/or conduct research participant visits independently.
• Assists supervising staff with regulatory submissions to the Institutional Review Board (IRB). May work directly with the Institutional Review Board to submit Adverse Events, Serious Adverse Events, Safety Letters, etc in accordance with local and federal guidelines.
• Assists with clinical trial budgets and patient billing.
• Responsible for sample preparation and shipping and maintenance of study supplies and kits.
• Ensures compliance with protocol and overall clinical research objectives. 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.
• May serve as the primary point of contact for external sponsors for select trials. Responds to sponsor inquiries and attends meetings regarding study activities.
• Participates in and provides training and education to other Clinical Research Associates. May assist in coordinating activities of other associates to ensure compliance with protocol and clinical research objectives.
• Participates in centralized activities such as auditing, Standard Operating Procedure development, etc.
• May participate in the development of Investigator Initiated trials for Investigational New Drug applications and/or Device applications
• May provide coordination of minimal number of noncomplex research studies or projects independently. May provide coverage for study coordination activities of supervising staff when needed to ensure minimal disruption to study objectives.

Education:

• High School Diploma/GED is required. Bachelor's degree in Science, Sociology, or a related field is preferred.

Licenses:

• Certification in Clinical Research from SOCRA or ACRP is preferred.

Experience:

• One (1) year of clinical research related experience is required.