Clinical Research Associate I - Surgery Chair

Cedars-Sinai•Los Angeles, CA
•$25 - $34

About The Position

The Clinical Research Associate I works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to support the coordination and implementation of noncomplex research studies. The role supports study objectives through tasks such as data collection, prescreening and scheduling research participants, assisting with IRB submissions, supporting budgets and billing, and ensuring compliance with applicable federal and local guidelines.

Requirements

  • High school diploma or GED.

Nice To Haves

  • Bachelor's degree in science, sociology, or a related field.
  • One year of clinical research-related experience.

Responsibilities

  • Support the coordination and implementation of noncomplex research studies under the direction of supervising staff.
  • Collect, evaluate, and/or abstract clinical research data; may assist in designing data collection or abstraction forms.
  • Enter and process clinical research data in sponsor-provided Electronic Data Systems (EDCs).
  • Complete Case Report Forms (CRFs).
  • Assist with prescreening potential research participants for clinical trials.
  • Schedule research participants for research visits and procedures.
  • Provide supervised patient contact or independent patient contact for long-term follow-up patients only.
  • Assist supervising staff with Institutional Review Board (IRB) regulatory submissions, including Adverse Events, Serious Adverse Events, and Safety Letters, in accordance with local and federal guidelines.
  • Assist with clinical trial budgets and patient research billing.
  • Prepare and ship samples and maintain study supplies and kits.
  • Ensure compliance with study protocols, research objectives, federal and local agency requirements, Good Clinical Practice (GCP) guidelines, and HIPAA and applicable privacy laws.
  • May serve as a point of contact for external sponsors on select trials, respond to sponsor inquiries, and attend meetings about study activity under the direction of supervising staff.
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