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    clinical research regulatory coordinator i - Birmingham, United States - UAB

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    Regular
    Description
    CLINICAL RESEARCH REGULATORY COORDINATOR I-(T Description

    The University of Alabama at Birmingham (UAB), Department Ped - Hematology/Oncology, is seeking a Clinical Research Regulatory Coordinator I.

    General Responsibilities

  • To assist in maintaining regulatory documentation including consent forms, protocols, 1572s, CVs, licenses, investigator brochures, recruitment materials, safety reports, and submission forms.
  • To assist with preparation of Institutional Review Board (IRB) submissions including preparing all relevant documentation and obtaining necessary signatures to meet study timelines.
  • To assist with initial drafts of informed consent documents.
  • To prepare regulatory binders and associated documentation.
  • Key Duties & Responsibilities

  • Enters protocol specific data into required institutional systems (IRAP and OnCore).
  • Maintains Delegation of Authority logs.
  • Tracks and maintains documentation of training, medical licenses, CVs, etc. for key personnel.
  • Updates investigator registrations in the CTEP RCR system.
  • Assists with registration membership for new employees with Children's Oncology Group, CTEP RCR, and other external systems.
  • Scans and archives paper regulatory documents.
  • Performs other duties as assigned.
  • Annual Salary Range: $39,215 - $63,725

    Qualifications

    High School diploma or GED required.

    Primary Location

    :University

    Job Category

    :Clinical Research

    Organization

    : Ped - Hematology/Oncology

    Employee Status

    :RegularShift:Day/1st ShiftWork Arrangement (final schedule to be determined by the department/hiring manager):Onsite

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