Clinical Research Coordinator II

1 week ago

Los Angeles, California, United States Cedars Sinai Full time
Job Summary

The Clinical Research Coordinator II is responsible for providing study coordination, including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. This role requires independent study coordination, scheduling patients for research visits and procedures, and maintaining accurate source documents related to all research procedures. Additionally, the Clinical Research Coordinator II is responsible for accurate and timely data collection, documentation, entry, and reporting, including timely response to sponsor queries.

Key Responsibilities

  • Provide study coordination, including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process.
  • Schedule patients for research visits and procedures.
  • Maintain accurate source documents related to all research procedures.
  • Responsible for accurate and timely data collection, documentation, entry, and reporting, including timely response to sponsor queries.
  • Participate in monitoring and auditing activities.
  • Responsible for compiling and reporting on each study, including information related to protocol activity, accrual data, workload, and other research information.
  • Notify direct supervisor about concerns regarding data quality and study conduct.
  • Work closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
  • May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
  • 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.
  • May coordinate training and education of other personnel.
  • May participate in centralized activities, such as auditing, Standard Operating Procedure development, etc.
  • May plan and coordinate strategies for increasing patient enrollment, and/or improving clinical research efficiency.
  • May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
  • May identify new research opportunities and present to investigators.
Requirements

  • High School Diploma/GED required.
  • Bachelor's Degree in Science, Sociology, or related degree preferred.
  • Master's Degree strongly preferred.
  • SOCRA or ACRP certification preferred.
  • Two (2) years of clinical research related experience required.

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