Clinical Research Associate I

5 days ago

Sacramento, California, United States CEDARS-SINAI Full time
Job Summary

Cedars-Sinai is seeking a highly motivated Clinical Research Associate I to join our team in the Department of Pediatrics - Pediatric Nephrology. This part-time position will be responsible for coordinating and implementing clinical research studies, ensuring compliance with protocol and research objectives, and providing limited patient contact as needed.

Key Responsibilities
  • Coordinate and implement clinical research studies, including evaluating and abstracting research data and 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 only.
  • Assist 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.
  • Assist with clinical trial budgets and patient research billing.
  • Schedule patients for research visits and research procedures.
  • Responsible for sample preparation and shipping and maintenance of study supplies and kits.
  • Ensure compliance with all federal and local agencies, including the Food and Drug Administration (FDA) and local Institutional Review Board.
  • Maintain research practices using Good Clinical Practice (GCP) guidelines.
  • Maintain strict 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 in Science, Sociology, or related degree preferred.
  • One (1) year of clinical research-related experience preferred.
About Cedars-Sinai

Cedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine, and research. We are committed to transforming healthcare for the benefit of patients and the community.

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