Clinical Research Data Associate I (Hybrid)

Company: CEDARS-SINAI
Location: Beverly Hills
Posted on: November 7, 2024

Job Description:

Job DescriptionPrimary Duties and ResponsibilitiesThe 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 Duties and 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 follow-up 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.
  QualificationsRequirements:
  • High School Diploma/GED required. Bachelor's Degree preferred.#Jobs-Indeed
    Req ID : 3700
    Working Title : Clinical Research Data Associate I (Hybrid)
    Department : Cancer - SOCCI Clinical Research
    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 : $23.00 - $29.87

Keywords: CEDARS-SINAI, Laguna Niguel , Clinical Research Data Associate I (Hybrid), Healthcare , Beverly Hills, California