Senior Clinical Research Regulatory Coordinator

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

Job summary

University of Alabama at Birmingham (UAB) is seeking a Clinical Research Regulatory Coordinator II for the O'Neal Comprehensive Cancer Center. You will handle regulatory submissions, maintain essential documents, and assist in IND/IDE filings in a hospital research setting.

The role requires a related bachelor's degree with experience, strong knowledge of OnCore and RedCap, and excellent communication and leadership abilities. Onsite work arrangement with standard day shifts is expected.

Qualifications

• Bachelor's degree in a related field with 3 years of related experience required.
• Work experience may substitute for the education requirement.
• Strong understanding of clinical trial operations, regulatory processes, OnCore and RedCap.
• Excellent communication, organizational and leadership skills.

Responsibilities

• Prepare, submit, and assist with IRB submissions, educational materials, reports, and grant renewal reports.
• Maintain regulatory documentation including consent forms, protocols, 1572s, CVs, licenses, brochures, and safety reports.
• Draft informed consents.
• Prepare and maintain FDA applications for INDs and IDEs.
• Assist in drafting compliant advertisements.
• Mentor junior regulatory staff and train others as needed.

Skills

Regulatory operations

Clinical trials

OnCore

RedCap

Communication

Leadership

Organizational skills

Education

Bachelor's degree + 3 years related experience

3 years related experience

Tools

IRB submission systems

Job description

University of Alabama at Birmingham (UAB) is seeking a Clinical Research Regulatory Coordinator II for the O'Neal Comprehensive Cancer Center. You will handle regulatory submissions, maintain essential documents, and assist in IND/IDE filings in a hospital research setting.

The role requires a related bachelor's degree with experience, strong knowledge of OnCore and RedCap, and excellent communication and leadership abilities. Onsite work arrangement with standard day shifts is expected.