CLINICAL RESEARCH REGULATORY COORDINATOR I

University of Alabama, Birmingham, United States

Updated: 20 days ago
Location: Birmingham, ALABAMA

Details

Posted: 10-Apr-24

Location: Birmingham, Alabama

Type: Full-time

Salary: Open

Categories:


Staff/Administrative

Internal Number: T215859


CLINICAL RESEARCH REGULATORY COORDINATOR I - (T215859)

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
    : 311652600 Ped - Hematology/Oncology
    Employee Status
    : Regular
    Shift: Day/1st Shift
    Work Arrangement (final schedule to be determined by the department/hiring manager): Onsite

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