Clinical Research Associate I - Department of Medicine

Cedars-SinaiLos Angeles, CA
233d$19 - $32

About The Position

Cedars-Sinai is a hub for biomedical research and a training center for future physicians and other healthcare professionals. By joining us in an academic role, you'll be a part of formulating future ideas for discovery and then translating those discoveries into cures for the benefit and health of the Los Angeles community. The Clinical Research Associate I will work under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of complex research studies. The incumbent will support objectives of research studies through complex tasks such as data collection, prescreening of and scheduling of current research participants, assisting in IRB submission activities, budget and billing, and ensuring overall compliance with all federal and local guidelines.

Requirements

  • High School Diploma/GED is required.
  • Clinical research experience is preferred.

Responsibilities

  • Collects, evaluates and/or abstracts clinical research data.
  • May assist in designing forms for data collection/abstraction.
  • Enters and processes clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
  • Completes Case Forms (CRFs).
  • Schedules research participants for research visits and research procedures.
  • Provides supervised patient contact or independent patient contact for long term follow-up patients only.
  • Assists supervising staff with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
  • Assists with clinical trial budgets and patient research billing.
  • Responsible for sample preparation and shipping and maintenance of study supplies and kits.
  • Ensures compliance with protocol and overall clinical research objectives.
  • 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.

Benefits

  • Healthcare
  • 401(K)/Retirement Plans
  • Continuing Education
  • Relocation Reimbursement
  • Professional Development
  • Work/Life Balance
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