CLINICAL RESEARCH REGULATORY COORDINATOR I (4)

UAB Medicine; University (FL); Hybrid; USD 25,000 - 43,000; Full time

Job summary

The University of Alabama at Birmingham (UAB) Clinical Research Support Enterprise seeks a Clinical Research Regulatory Coordinator I to assist with regulatory aspects of diverse studies, including industry-sponsored and federally funded projects. You will help manage regulatory documents, IRB submissions, and ensure GCP compliance.

This entry-level role emphasizes attention to detail, teamwork, and timely document handling; day shift with Remote/Hybrid eligibility and opportunity to grow in a

Qualifications

• Experience in clinical research or regulatory documentation is a plus.
• Familiarity with IRB processes and regulatory submissions is desirable.
• Strong written and verbal communication with keen attention to detail.

Responsibilities

• Assist in maintaining regulatory documentation including consent forms, protocols, 1572s, CVs, licenses, investigator brochures, recruitment materials, safety reports, and submission forms.
• Assist with preparation of Institutional Review Board (IRB) submissions, including preparing all relevant documentation and obtaining necessary signatures to meet study timelines.
• Assist with initial drafts of informed consent documents.
• Prepare regulatory binders and associated documentation.
• Enter protocol specific data into required institutional systems (IRAP and OnCore).

Skills

Clinical research

Regulatory knowledge

Microsoft Office

Attention to detail

Communication

Education

High School diploma

Tools

Microsoft Office

Job description

CLINICAL RESEARCH REGULATORY COORDINATOR I (3)

The University of Alabama at Birmingham (UAB), Clinical Research Support Enterprise, is seeking a Clinical Research Regulatory Coordinator I. This position supports the regulatory aspects of clinical research studies, including industry-sponsored, federally funded, and investigator-initiated research. The role includes assisting with IRB submissions, maintaining regulatory documentation, and supporting compliance with federal regulations, Good Clinical Practice (GCP), and institutional requirements.

General Responsibilities

• To assist in maintaining regulatory documentation including consent forms, protocols, 1572s, CVs, licenses, investigator brochures, recruitment materials, safety reports, and submission forms.
• To assist with preparation of Institutional Review Board (IRB) submissions including preparing all relevant documentation and obtaining necessary signatures to meet study timelines.
• To assist with initial drafts of informed consent documents.
• To prepare regulatory binders and associated documentation.

Key Duties & Responsibilities

1. Assists in maintaining regulatory documentation including consent forms, protocols, 1572s, CVs, licenses, investigator brochures, recruitment materials, safety reports, and submission forms.
2. Assists with preparation of Institutional Review Board (IRB) submissions, including preparing all relevant documentation and obtaining necessary signatures to meet study timelines.
3. Assists with initial drafts of informed consent documents.
4. Prepares regulatory binders and associated documentation.
5. Enters protocol specific data into required institutional systems (IRAP and OnCore).
6. Maintains Delegation of Authority logs.
7. Performs other duties as assigned.

Hourly Range

$18.85 - $30.65

Qualifications

High School diploma or GED required.

Preferences

Preferred Hard Skills: Clinical research, healthcare, or regulatory experience preferred. Familiarity with IRB processes or regulatory documentation is a plus. Strong computer skills, including Microsoft Office.

Preferred Soft Skills: Strong attention to detail and organizational skills. Excellent written and verbal communication. Ability to manage multiple priorities and regulatory submission deadlines. Collaborative and proactive Willingness to learn and grow in a fast-paced regulatory environment.

UAB is an Equal Employment/Equal Educational Opportunity Institution dedicated to providing equal opportunities and equal access to all individuals regardless of race, color, religion, ethnic or national origin, sex (including pregnancy), genetic information, age, disability, and veteran's status. As required by Title IX, UAB prohibits sex discrimination in any education program or activity that it operates. Individuals may report concerns or questions to UAB's Assistant Vice President and Senior Title IX Coordinator. The Title IX notice of nondiscrimination is located at uab.edu/titleix.

Primary Location

University

Job Category

Clinical Research

Organization

310009510 Clinical Research Support Enterprise

Employee Status

Regular

Shift

Day/1st Shift

Work Arrangement (final schedule to be determined by the department/hiring manager)

Remote/Hybrid Eligible