Clinical Research Associate I - Regenerative Medicine Institute

Company: Cedars-Sinai
Location: Alhambra
Posted on: May 24, 2023

Job Description:

Join us as we translate today's discoveries into tomorrow's medicine!Regenerative medicine is a new and developing field that aims to restore function in diseased or aged tissues through either revitalizing existing cells or transplanting new ones. At the Board of Governors Regenerative Medicine Institute, researchers are turning stem cells into therapies for treating a multitude of prevalent diseases and conditions. We're also exploring how to prevent diseases and we're extending our knowledge to students in Los Angeles and researchers around the world.To learn more, please visit--Are you ready to be a part of breakthrough research?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 Duties & Responsibilities:

• 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 and patient research billing.
• 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.
• 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.
• Assists with sample processing.
• Assists with form creations.
• May assist with animal work.Education:
  • High School Diploma is required. Bachelor's degree preferred in Science, Sociology, or related field, is preferred.Experience and Skills:
    • Understanding of general clinical research objectives. One (1) year of clinical research experience is preferred.
    • Ability to interpret and apply knowledge of State, Federal and Agency standards to comply with regulations.
    • Must possess computer skills, including Word and Excel, and the ability to use standard office equipment is required.Working Title: Clinical Research Associate I - Regenerative Medicine InstituteDepartment: Regenerative Medicine InstBusiness Entity: Cedars-Sinai Medical CenterJob Category: Academic/ResearchJob Specialty: Research Studies/Clinical TrialsPosition Type: Full-timeShift Length: 8 hour shiftShift Type: DayBase Pay:$17.57 - $29.87

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