Clinical Research Associate I - Smidt Heart Institute

Grow your career at Cedars-Sinai!

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.

Join our team and use your skills with an organization known nationally for excellence in 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 And Responsibilities

• Schedules patients for research visits and research procedures.
• Maintains research practices using Good Clinical Practice (GCP) guidelines.
• Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
• Ensures compliance with protocol and overall clinical research objectives.
• Evaluates and abstracts clinical research data from source documents.
• Assists with patient research billing.
• Assists with clinical trial budgets.
• Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study.
• Responsible for sample preparation and shipping and maintenance of study supplies and kits.
• 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.
• Participates in required training and education programs.
• Completes Case Report Forms (CRFs).
• Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
• Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
• Provides supervised patient contact or patient contact for long term follow-up patients only.

Education

• Highschool diploma/GED required
• Bachelor's Degree in Science, Sociology or related degree preferred

Experience

• 1-year Clinical Research Related Experience

Working Title: Clinical Research Associate I - Smidt Heart Institute

Department: Heart Institute Operations

Business Entity: Cedars-Sinai Medical Center

Job Category: Academic/Research

Job Specialty: Research Studies/Clinical Trials

Position Type: Full-time

Shift Length: 8 hour shift

Shift Type: Day

Base Pay:$19.50 - $29.87