Clinical Research Coordinator II - Pediatric Neurology & Genetics

CEDARS-SINAI

Camarillo, CAFull-timePosted Apr 25, 2026

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Qualifications

  • •High School Diploma/GED required

Responsibilities

  • •The Clinical Research Coordinator II works independently 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
  • •Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries
  • •Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information
  • •Presents information at regular research staff meetings
  • •May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities
  • •Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB)
  • •Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process
  • •Schedules patients for research visits and procedures
  • •In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug
  • •Maintains 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
  • •Schedules and participates 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; present this information at regular research staff meetings
  • •Notifies direct supervisor about concerns regarding data quality and study conduct
  • •Works 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
  • •Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA and local Institutional Review Board
  • •Maintains research practices using Good Clinical Practice (GCP) guidelines
  • •Maintains 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
  • •Participates in required training and education programs
  • •22 more items(s)
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