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Clinical Research Coordinator II - Biomedical Imaging Research Institute

Company: Cedars-Sinai
Location: Bell Gardens
Posted on: November 16, 2022

Job Description:

Do you have a passion for the highest quality and patient happiness? Then please respond to this dynamic opportunity available with one of the best places to work in Southern California! We would be happy to hear from you. he Cedars-Sinai Biomedical Imaging Research Institute (BIRI) is an interdisciplinary research program established in 2010 to develop and apply state-of-the-art imaging technologies to todays most pressing translational research and clinical questions. Our mission is to improve the diagnosis, prevention and treatment of diseases by developing novel medical imaging technology. To learn more, please visitBiomedical Imaging Research Institute - Cedars-Sinai Are you ready to be a part of breakthrough research? The Clinical Research Coordinator II works independently providing study coordination including screening potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents information at regular research staff meetings. May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB). Primary Duties and Responsibilities:

  • Schedules patients for research visits and procedures.
  • In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
  • Maintains accurate source documents related to all research procedures.
  • Schedules and participates in monitoring and auditing activities.
  • Notifies direct supervisor about concerns regarding data quality and study conduct.
  • Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
  • May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
  • Maintains research practices using Good Clinical Practice (GCP) guidelines.
  • Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
  • May coordinate training and education of other personnel.
  • May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
  • May plan and coordinate strategies for increasing patient enrollment, and/or improving clinical research efficiency.
  • May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
  • May identify new research opportunities and present to investigators
  • Participates in required training and education programs. Department-Specific Responsibilities:
    • Schedules appointments in the iLab research appointment calendar and sends out invites in the Outlook calendar
    • Keeps track of refrigerator and room temperature (supportive role)
    • Orders and keeps inventory of research compensation cards and parking validation passes
    • Uses Electronic Medical Records (CS-Link) for patient/study subject chart review for research
    • Assists in clinical patient scheduling (supportive role).
    • Assists in monthly radiation dosimeter badge dispensation to teammates and the return of old ones to the safety office (supportive role). Education:
      • High School Diploma/GED is required. Bachelor's degree preferred. Experience and Skills:
        • Two (2) years minimum of directly related experience required.
        • Establishes effective working relationships with cross-functional team(s).
        • Ability to use discretion and maintain privacy, confidentiality or anonymity.
        • Ability to interpret and apply knowledge of State, Federal and Agency standards to comply with regulations.
        • Ability to convey and/or receive written/verbal information to/from various audiences in different formats. Licenses/Certifications:
          • ACRP/SoCRA (or equivalent) certification, preferred. Working Title:Clinical Research Coordinator II - Biomedical Imaging Research Institute Department:BMS - BioMed Imaging Res Inst Business Entity:Academic / Research Job Category:,Academic/Research,Academic/Research Job Specialty:Research Studies/Clinical Trials Position Type:Full-time Shift Length:8 hour shift Shift Type:Day

Keywords: Cedars-Sinai, Bell Gardens , Clinical Research Coordinator II - Biomedical Imaging Research Institute, Healthcare , Bell Gardens, California

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