Clinical Research Coordinator I - Department of Surgery
Cedars Sinai
 West Hollywood, CA

As a Clinical Research Coordinator I, you will perform 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. Your day to day responsibilities will include:

  • Scheduling of 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, responsible 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, preset 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 involve 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 IRB.
  • Maintains research practices using Good Clinical Practice (GCP) guidelines.
  • Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
  • Participates in required training and education programs.

Educational Requirements:

  • BA/BS degree preferred

License/Certification Requirements:

  • ACRP/SoCRA (or equivalent) certification preferred

Experience:

  • Two (2) years of directly related experience
  • Working Title: Clinical Research Coordinator I - Department of Surgery
  • Department: Home Dept - Gewertz
  • Business Entity: Academic / Research
  • City: West Hollywood
  • Job Category: Compliance/Quality
  • Job Specialty: Research Compliance
  • Position Type: Full-time
  • Shift Length: 8 hour shift
  • Shift Type: Day