Clinical Research Associate I - Heart Institute - Makkar Lab

Cedars-Sinai•Los Angeles, CA
•$25 - $34

About The Position

The Clinical Research Associate I works under the supervision of Principal Investigator and Research Scientist Dr. Raj Makkar and under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff. The role assists with coordinating and implementing noncomplex research studies and supports research objectives through data collection, candidate evaluation, participant scheduling, IRB assistance, budget management, and regulatory compliance.

Requirements

  • High school diploma or GED.
  • Maintain patient confidentiality in accordance with HIPAA regulations and applicable law.
  • Maintain research practices using Good Clinical Practice (GCP) guidelines.

Nice To Haves

  • Bachelor's degree in Science, Sociology, or a related field.
  • One year of clinical research-related experience.

Responsibilities

  • Work with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and implement studies.
  • Evaluate and abstract clinical research data from source documents.
  • Ensure compliance with the protocol and overall clinical research objectives.
  • Complete Case Report Forms (CRFs).
  • Enter clinical research data into sponsor-provided Electronic Data Systems (EDCs).
  • Provide supervised patient contact or patient contact for long-term follow-up patients only.
  • Assist with Institutional Review Board (IRB) regulatory submissions, including Adverse Events, Serious Adverse Events, and Safety Letters, in accordance with local and federal guidelines.
  • Assist with clinical trial budgets.
  • Assist with patient research billing.
  • Assist with prescreening potential research participants for clinical trials.
  • Schedule patients for research visits and procedures.
  • Prepare and ship samples and maintain study supplies and kits.
  • Ensure compliance with federal and local agencies, including the Food and Drug Administration (FDA) and the 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.
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