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