Clinical Research Associate I - Heart Institute - Berman Lab

Cedars-Sinai

Posted 2 months ago

Full Time

Los Angeles, California

In Person

Smart Summary

Responsibilities

The Clinical Research Associate I assists in the coordination and implementation of clinical studies, including data abstraction, entry into electronic systems, and regulatory compliance. They also support patient scheduling, sample management, and financial tasks such as trial budgets and research billing.

Qualifications

You have experience coordinating clinical research studies, ensuring compliance with protocols, and managing data. You are responsible for completing case report forms, entering data into electronic systems, and assisting with regulatory submissions to the IRB, all while adhering to HIPAA and GCP guidelines.

Must Have Skills for ATS

Clinical Research Coordinator

Case Report Forms

Electronic Data Systems

Institutional Review Board

HIPAA

Good Clinical Practice

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 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:

  • 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.
  • 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.

Cedars-Sinai

Since its beginning in 1902, Cedars-Sinai has evolved to meet the healthcare needs of one of the most diverse regions in the nation, continually setting new standards for quality and innovation in patient care, research, teaching and community service. Today, Cedars-Sinai is widely known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai receives consistent recognition for our excellence. Our awards include; being named one of America’s Best Hospitals by U.S. News & World Report, receiving the National Research Corporation’s Consumer Choice Award 19 years in a row for providing the highest-quality medical care in Los Angeles, achieving the longest-running Magnet designation for nursing excellence in California, and being recognized as The Advisory Board Company’s 2017 Workplace of the Year, an award Cedars-Sinai has won three years in a row. This annual award recognizes hospitals and health systems nationwide that have outstanding levels of employee engagement. Cedars-Sinai is a leader in the clinical care and research of heart disease, cancer and brain disorders, among other areas. Pioneering research achievements include using cardiac stem cells to repair damaged hearts, developing minimally invasive surgical techniques and discovering new types of drugs to target cancer more precisely. Cedars-Sinai also impacts the future of healthcare through education programs that encompass everything from highly competitive medical residency and fellowship programs to a biomedical science and translational medicine PhD program, advanced training for nurses and educational opportunities for allied health professionals. Most notably, Cedars-Sinai demonstrates a longstanding commitment to strengthening the Los Angeles community through wide-ranging programs that improve the health of its most vulnerable residents.
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