Clinical Research Associate I, Per Diem - Beverly Hills, United States - CEDARS-SINAI

Mark Lane

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Mark Lane

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Description

The Clinical Research Associate I works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study.

Evaluates and abstracts research data and ensures compliance with protocol and research objectives. Responsible for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited patient contact as needed for study and assist with study budget and patient research billing.

Ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.

Primary


Responsibilities:


  • Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study.
  • Evaluates and abstracts clinical research data from source documents.
  • Ensures compliance with protocol and overall clinical research objectives.
  • Completes Case Report Forms (CRFs).
  • Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
  • Provides supervised patient contact or patient contact for long term followup patients only.
  • Assists 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.
  • Assists with patient research billing.
  • Schedules patients for research visits and research procedures.
  • Responsible for sample preparation and shipping and maintenance of study supplies and kits.
  • 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.
  • Participates in required training and education programs.

Qualifications:


Requirements:


  • High School Diploma/GED required. Bachelor's Degree preferred.
  • 1 year Clinical Research Related Experience preferred.
Jobs-Indeed


Req ID : 2237


Working Title :
Clinical Research Associate I, Per Diem


Department :
Cancer - Research Center Health Equity


Business Entity :
Cedars-Sinai Medical Center


Job Category :
Academic / Research


Job Specialty :
Research Studies/ Clin Trial


Overtime Status :

NONEXEMPT

Primary Shift :
Day


Shift Duration : 8 hour


Base Pay :
$ $29.87

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