Clinical Research Associate I - Heart Institute - Makkar Lab

Cedars-Sinai Medical Center; Los Angeles (CA); Vor Ort; USD 70.000 - 90.000; Vollzeit

Zusammenfassung

Cedars-Sinai Medical Center is seeking a Clinical Research Associate I to support coordination of noncomplex studies under supervision. You will assist with data collection, participant scheduling, IRB tasks, and regulatory compliance within a dynamic research environment.

The role involves sample handling, budget assistance, and ensuring adherence to Good Clinical Practice while maintaining patient confidentiality in line with HIPAA regulations.

Qualifikationen

• Education requirements: High School Diploma or GED; Bachelor’s degree preferred.
• Experience: 1 year clinical research experience preferred.

Aufgaben

• Coordinate/implement study with CRAs, coordinators or nurses.
• Abstract and evaluate clinical research data from source documents.
• Ensure protocol compliance with study objectives.
• Complete Case Report Forms (CRFs).
• Enter data into sponsor-provided EDC systems.
• Assist with IRB submissions and regulatory tasks.
• Assist with clinical trial budgets and patient research billing.
• Pre-screen potential research participants and schedule visits.

Kenntnisse

Data collection

Participant scheduling

Regulatory compliance

IRB submissions

GCP compliance

Ausbildung

High School Diploma/GED

Bachelor's degree in Science, Sociology, or related field

Tools

EDC systems

Jobbeschreibung

Job Description

Grow your career at Cedars-Sinai!

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.

What will you be doing in this role?

The Clinical Research Associate I works under the supervision of Principal Investigator and Research Scientist Dr. Raj Makkar and under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies. Supports research objectives through tasks like data collection, candidate evaluation, participant scheduling, IRB assistance, budget management, and regulatory compliance.

Primary Duties & Responsibilities:

• Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study.
• 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) that the sponsors provide.
• 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.
• Assists with prescreening of potential research participants for various clinical trials.
• 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.

Qualifications

Education:

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

Experience:

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