Job Title 

The University of Alabama at Birmingham (UAB), Med - Cardiovascular Disease is seeking a Clinical Research Regulatory Coordinator I. We are seeking a Clinical Research Regulatory Coordinator I to join our multidisciplinary Cardiovascular Clinical and Translational Research Program to carry out regulatory duties to support the NIH and Industry Sponsored clinical trials.

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. Performs other duties as assigned.

Hourly Range:    $18.85 - $30.65

High School diploma or GED required.

Preferences

• Interpersonal skills. 
• Knowledge of Microsoft Office products. 
• Written and verbal communication skills. 
• Knowledge of regulatory documentation, including consent forms, protocols, 1572s, CVs, licenses, investigator brochures, recruitment materials, safety reports, and submission forms.