Senior Clinical Research Regulatory Coordinator

University of Alabama at Birmingham; Birmingham (AL); On-site; USD 55,000 - 90,000; Full time

Job summary

The University of Alabama at Birmingham, O'Neal Comprehensive Cancer Center, is seeking a Clinical Research Regulatory Coordinator III to manage regulatory submissions, IND/IDE filings, and quality initiatives within cancer research programs.

This role partners with clinical staff, IRB, sponsors, and departments to ensure compliance, trains staff, and maintains SOPs while advancing efficient, compliant trial operations.

Qualifications

• Bachelor's degree in a related field is required.
• Five (5) years of related experience required.
• Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) preferred.

Responsibilities

• Prepare and submit multiple levels of research documentation (IRB submissions, educational materials, reports, grant renewal reports, study forms).
• Prepare and maintain FDA applications for INDs and IDEs.
• Lead the implementation of study-specific regulatory processes of a moderate to complex nature.
• Conduct internal quality assurance audits of regulatory files and programs.

Skills

Critical thinking

Problem solving

Organizational skills

Written and verbal communication

Independent work

Education

Bachelor's degree in related field

Tools

ICH-GCP guidelines

Job description

The University of Alabama at Birmingham, O'Neal Comprehensive Cancer Center, is seeking a Clinical Research Regulatory Coordinator III to manage regulatory submissions, IND/IDE filings, and quality initiatives within cancer research programs.

This role partners with clinical staff, IRB, sponsors, and departments to ensure compliance, trains staff, and maintains SOPs while advancing efficient, compliant trial operations.