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Clinical Research Coordinator I - Smidt Heart Institute (Bello Lab)

Company: CEDARS-SINAI
Location: Altadena
Posted on: November 16, 2022

Job Description:

Grow your career at Cedars-Sinai!The Smidt Heart Institute reflects Cedars-Sinai's steadfast commitment to heart disease and research innovation giving patients access to the highest level of care. Year after year, thousands of people trust their hearts to Smidt Heart Institute at Cedars-Sinai. Our cardiologists, cardiac surgeons and specialized care teams treat the full spectrum of heart disease and disorders, while our investigators continue to advance the field with groundbreaking, life-saving research. From genetic counseling and targeted drug therapies to an increasing array of minimally invasive procedures, Cedars-Sinai continues to stand at the forefront of technology, innovation and discovery improving patient outcomes.Join our team and use your experience with an organization known nationally for excellence in research!The Clinical Research Coordinator I works independently providing study coordination, screening of 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 study information at research staff meetings. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).Duties and Responsibilities

  • Schedules patients for research visits and procedures.
  • In collaboration with the physician and other medical personnel, documents 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.
  • Participates in required training and education programs.
  • Performs phlebotomy services according to CSMC policies and procedures.
  • Verifies specimen identification, assesses appropriateness of test orders and quality of specimen by recognizing
    Requirements:
    • High School Diploma/GED required
    • Bachelor's Degree Science, Sociology or related degree preferred
    • One year of Clinical Research Related experience required
    • Certification in clinical Research: SOCRA or ACRP certification preferred
      Working Title:Clinical Research Coordinator I - Smidt Heart Institute (Bello Lab)
      Department:Heart Institute Operations
      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, Altadena , Clinical Research Coordinator I - Smidt Heart Institute (Bello Lab), Healthcare , Altadena, California

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