Clinical Research Regulatory Coordinator II — IRB & FDA Submissions

ScholarLink Inc.; Birmingham (AL); On-site; USD 55,000 - 75,000; Full time

Job summary

The University of Alabama at Birmingham is seeking a Clinical Research Regulatory Coordinator II to oversee regulatory compliance for clinical studies. You will manage IRB submissions, prepare FDA documentation, and maintain essential regulatory files.

You will coordinate with study teams to ensure adherence to HIPAA, OHRP, and FDA requirements, draft consent templates, and support QA audits. Strong project management and communication are essential in this role.

Qualifications

• Knowledge of federal regulations (HIPAA, FDA, OHRP).
• Experience with IRB submission processes.
• Proficiency with electronic databases (MURE, IRAP, Veeva Vault, Florence e-binder).

Responsibilities

• Prepare, submit, and track IRB applications and amendments.
• Maintain regulatory documentation including consent forms, protocols, CVs, licenses.
• Draft informed consents and assist with FDA applications (INDs, IDEs).
• Assist in drafting compliant advertisements.
• Serve as resource or consultant in regulatory area.
• Conduct QA audits for regulatory files.

Skills

Regulatory knowledge

IRB submissions

Project management

Tools

MURE

IRAP

Veeva Vault

Florence e-binder

Job description

The University of Alabama at Birmingham is seeking a Clinical Research Regulatory Coordinator II to oversee regulatory compliance for clinical studies. You will manage IRB submissions, prepare FDA documentation, and maintain essential regulatory files.

You will coordinate with study teams to ensure adherence to HIPAA, OHRP, and FDA requirements, draft consent templates, and support QA audits. Strong project management and communication are essential in this role.