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Clinical Research Associate I

2 months ago


San Diego, California, United States CEDARS-SINAI Full time
Clinical Research Associate I Job Description

Cedars-Sinai Medical Center is seeking a highly motivated and detail-oriented Clinical Research Associate I to join our team in the Cancer - Research Center Health Equity department.

Key Responsibilities:
  • Collaborate with Clinical Research Coordinators, Research Program Administrators, and Research Nurses to coordinate and implement clinical trials.
  • Evaluate and abstract research data from source documents, ensuring compliance with protocol and research objectives.
  • Complete Case Report Forms (CRFs) and enter clinical research data into Electronic Data Systems (EDCs) provided by sponsors.
  • Provide supervised patient contact or patient contact for long-term follow-up patients, as needed.
  • Assist with regulatory submissions to the Institutional Review Board (IRB), including submission of Adverse Events, Serious Adverse Events, and Safety Letters.
  • Contribute to clinical trial budgets and patient research billing.
  • Schedule patients for research visits and procedures, and maintain study supplies and kits.
  • Ensure compliance with federal, local, and FDA guidelines, as well as Good Clinical Practice (GCP) guidelines.
  • Maintain patient confidentiality according to HIPAA regulations and applicable law.
  • Participate in required training and education programs.
Requirements:
  • High School Diploma/GED required; Bachelor's Degree preferred.