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Clinical Research Regulatory Coordinator I

4 months ago

University, United States University of Alabama at Birmingham Full time

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.

Hourly Range: $18.85 - $30.65

High School diploma or GED required.