Clinical Research Regulatory Coord II - Remote/Hybrid

University of Alabama at Birmingham; University (FL); Hybrid; USD 48,000 - 77,000; Full time

Job summary

The University of Alabama at Birmingham, O'Neal Comprehensive Cancer Center, seeks a Clinical Research Regulatory Coordinator II to manage regulatory documentation for multiple studies. You will prepare IRB submissions to UAB, WIRB, Advarra and others, maintain consent forms, protocols, and FDA files for INDs/IDEs, and act as a regulatory resource across trials.

This role requires a Bachelor's degree and at least three years in clinical research; remote/hybrid eligible, with day shift and

Qualifications

• Bachelor's degree required; three years of related experience preferred.
• Experience with IRB submissions and regulatory documentation is expected.
• Knowledge of FDA IND/IDE processes is advantageous.

Responsibilities

• Prepare, submit, and assist with multiple levels of research documentation (IRB submissions, reports, renewal materials).
• Maintain regulatory documentation including ICFs, protocols, CVs, licenses, recruitment materials and submissions.
• Draft informed consent documents and FDA applications for INDs/IDEs; provide regulatory guidance to the team.

Skills

Regulatory compliance

IRB submissions

FDA applications

Clinical trials knowledge

Communication skills

Education

Bachelor's degree in a related field

Job description

The University of Alabama at Birmingham, O'Neal Comprehensive Cancer Center, seeks a Clinical Research Regulatory Coordinator II to manage regulatory documentation for multiple studies. You will prepare IRB submissions to UAB, WIRB, Advarra and others, maintain consent forms, protocols, and FDA files for INDs/IDEs, and act as a regulatory resource across trials.

This role requires a Bachelor's degree and at least three years in clinical research; remote/hybrid eligible, with day shift and