Clinical Research Coordinator

5 days ago


Fountain Valley, California, United States Medix™ Full time
Clinical Research Coordinator Job Description

Job Summary:

The Clinical Research Coordinator will work independently to 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.

Key Responsibilities:

  • Independent study coordination, including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to patients, and participating in the informed consent process.
  • Scheduling of patients for research visits and procedures.
  • Documentation of patient information, including changes in patient condition, adverse events, concomitant medication use, protocol compliance, and response to study drug.
  • Maintenance of 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.
  • Scheduling and participation in monitoring and auditing activities.
  • Compilation and reporting of study information, including protocol activity, accrual data, workload, and other research information.
  • Notification of direct supervisor regarding concerns regarding data quality and study conduct.
  • Collaboration with regulatory coordinator or Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
  • Assistance with patient research billing and reconciliation.
  • Maintenance of research practices using Good Clinical Practice (GCP) guidelines.
  • Maintenance of patient confidentiality according to HIPAA regulations and applicable law.
  • Coordination of training and education of other personnel.
  • Participation in centralized activities, such as auditing, Standard Operating Procedure development, etc.

Requirements:

  • 2+ years of experience working as a Clinical Research Coordinator.
  • Bachelor's degree in a related discipline.
  • Oncology trial experience is a plus.


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