Heart Institute - Clinical Research Associate I, Susan Cheng Team

Cedars-Sinai•Los Angeles, CA

9h•Onsite

About The Position

The Smidt Heart Institute at Cedars-Sinai is dedicated to heart disease and research innovation, providing patients with the highest level of care. It treats the full spectrum of heart diseases and disorders, with investigators advancing life-saving research through genetic counseling, targeted drug therapies, and minimally invasive procedures. The Clinical Research Associate I works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement studies. This role involves evaluating and abstracting research data, ensuring compliance with protocol and research objectives, completing case report forms, and entering clinical research data. The position is also responsible for assisting with regulatory submissions to the IRB, providing limited patient contact as needed for the study, and assisting with study budgets and patient research billing. The role requires compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.

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 are provided by the 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) and works closely with supervising research staff or directly with the Institutional Review Board to submit Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
Assists with clinical trial budgets and patient research billing as needed
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.