Clinical Research Associate I

About the Role

The Karsh Division of Gastroenterology and Hepatology at Cedars-Sinai is seeking a Clinical Research Associate I to join Dr. Walid Ayoub's research team. This role involves coordinating and implementing studies, ensuring compliance with protocols, and managing research data.

Key Responsibilities

• Ensures compliance with protocol and overall clinical research objectives.
• Enters clinical research data into Electronic Data Systems (EDCs) provided by 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), including submitting Adverse Events, Serious Adverse Events, and Safety Letters.
• Assists with clinical trial budgets and 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 (IRB).
• Maintains research practices using Good Clinical Practice (GCP) guidelines.
• Maintains strict patient confidentiality according to HIPAA regulations.
• Participates in required training and education programs.

Requirements & Tech Stack

• High School Diploma/GED required.
• Bachelor's degree in Science, Sociology, or related degree is preferred.
• ACRP/SoCRA certification is preferred.
• Clinical research experience is highly preferred.
• Understanding of general research objectives.