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