CLINICAL RESEARCH REGULATORY COORDINATOR I (4)

University of Alabama at Birmingham; University (FL); Hybrid; USD 26,000 - 42,000; Full time

Job summary

The University of Alabama at Birmingham invites applications for the Clinical Research Regulatory Coordinator I. This role supports regulatory activities for clinical studies, including industry-sponsored, federally funded, and investigator-initiated projects.

Responsibilities include preparing IRB submissions, maintaining regulatory documents, managing consent forms and delegation logs, and ensuring compliance with GCP and institutional policies.

Qualifications

• High School diploma or GED is required.
• Familiarity with IRB processes or regulatory documentation is a plus.
• Strong computer skills, including Microsoft Office.

Responsibilities

• Maintain regulatory documentation (consent forms, protocols, 1572s, CVs, licenses, brochures, recruitment materials, safety reports, submission forms).
• Prepare IRB submissions with relevant documents and signatures to meet study timelines.
• Draft initial informed consent documents as needed.
• Prepare regulatory binders and related documentation.

Skills

Clinical research

Regulatory experience

IRB processes

Microsoft Office

Education

High School diploma or GED

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