Entry-Level Clinical Research Regulatory Coordinator (IRB & Compliance)

University of Alabama at Birmingham; Birmingham (AL); On-site; USD 26,000 - 34,000; Full time

Job summary

The University of Alabama at Birmingham (UAB) is seeking an entry-level Clinical Research Regulatory Coordinator I to support IRB submissions, regulatory documentation, and compliance monitoring. You will help prepare consent forms, protocols, and reviewer materials while learning ICH-GCP, HIPAA, and FDA regulations.

The role involves assisting with regulatory binders, site visits, and QA audits, with a focus on accurate documentation and timely submissions in a fast-paced research environment

Qualifications

• Entry-level regulatory role supporting IRB submissions and documentation.
• Familiarity with ICH-GCP, HIPAA, and human subjects protections.
• Willingness to learn FDA inspections, audits, and monitoring.
• Strong organizational skills and attention to detail.

Responsibilities

• Prepares, submits, maintains, and tracks IRB applications, amendments, and other regulatory documents.
• Maintains regulatory binders, licensures, and eISFs across studies.
• Supports site visits with sponsors and prepares for sponsor communications.
• Performs clerical tasks and ensures regulatory compliance.

Skills

IRB submissions

Regulatory knowledge

Documentation management

QA audits

Communication

Education

High School diploma or GED

Tools

MURE

IRAP

Florence e-binder system

Veeva Vault

Microsoft Office

Job description

The University of Alabama at Birmingham (UAB) is seeking an entry-level Clinical Research Regulatory Coordinator I to support IRB submissions, regulatory documentation, and compliance monitoring. You will help prepare consent forms, protocols, and reviewer materials while learning ICH-GCP, HIPAA, and FDA regulations.

The role involves assisting with regulatory binders, site visits, and QA audits, with a focus on accurate documentation and timely submissions in a fast-paced research environment