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CLINICAL RESEARCH REGULATORY COORDINATOR I

University of Alabama at Birmingham

University of Alabama at Birmingham

Legal
university, fl, usa
Posted 6+ months ago
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

  1. Enters protocol specific data into required institutional systems (IRAP and OnCore).
  2. Maintains Delegation of Authority logs.
  3. Tracks and maintains documentation of training, medical licenses, CVs, etc. for key personnel.
  4. Updates investigator registrations in the CTEP RCR system.
  5. Assists with registration membership for new employees with Children's Oncology Group, CTEP RCR, and other external systems.
  6. Scans and archives paper regulatory documents.
  7. Performs other duties as assigned.

Hourly Range: $18.85 - $30.65

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