CLINICAL RESEARCH REGULATORY COORDINATOR I

University of Alabama at Birmingham; University (FL); On-site; USD 20,664 - 34,440; Full time

Job summary

The University of Alabama at Birmingham (UAB) is seeking a Clinical Research Regulatory Coordinator I to support regulatory activities across the Pulmonary/Allergy/Critical Care division. This entry-level role focuses on assisting with IRB submissions, document oversight, and ensuring compliance with ICH-GCP, FDA, OHRP, HIPAA, and UAB policies.

Responsibilities include maintaining regulatory binders, assisting with audits, and learning federal regulations while coordinating with investigators

Qualifications

• High School diploma or GED required.
• Familiarity with ICH-GCP, FDA, OHRP, and HIPAA policies preferred.
• Experience with regulatory documentation and trackers is a plus.

Responsibilities

• Prepares, submits, maintains, and tracks IRB applications, CDAs, MTAs, DUAs, amendments, and other regulatory documents.
• Prepares for and participates in calls and meetings, site visits with sponsors.
• Maintains regulatory binders and licensures for clinicians.
• Conducts QA audits of regulatory files.
• Uses electronic databases necessary for operations.

Skills

Regulatory compliance

IRB submissions

FDA inspections readiness

HIPAA knowledge

Documentation management

Education

High School diploma or GED

Tools

MURE

IRAP

Florence e-binder

Veeva Vault

Job description

Job Description - CLINICAL RESEARCH REGULATORY COORDINATOR I (T237040)

The University of Alabama at Birmingham (UAB), Department of Med - Pulmonary/Allergy/Critical Care, is seeking a Clinical Research Regulatory Coordinator I.

This job position is for an entry-level regulatory specialist. Core responsibilities include assisting with project oversight, preparation, submission, and tracking of IRB applications (including continuing reviews, amendments, and reportable events). Responsibilities also include assisting with documentation oversight (regulatory binders, eISFs, logs, etc.), ensuring all documents meet ICH-GCP, FDA, OHRP, and UAB policies, and compliance monitoring (must be knowledgeable of or willing to learn federal regulations, human subjects protections, HIPAA, and informed consent processes).

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

Prepares, submits, maintains, and tracks IRB applications, CDAs, MTAs, DUAs, amendments, and other regulatory documents.

Prepares for and participates in calls and meetings, and participates in site visits with sponsors.

Prepares for, collects, and maintains documents for sponsor site visits.

Maintains regulatory binders and licensures for clinicians.

Conducts QA audits of regulatory files.

Uses electronic databases necessary for operations.

Performs other duties as assigned.

Hourly Range

$18.85 - $24.50

Qualifications

High School diploma or GED required.

Preferences

Candidate is expected to be knowledgeable of or willing to learn IRB submission processes of complex, high-risk trials and capable of advising investigators and leadership on regulatory processes and risk mitigation.

Candidate is expected to help prepare and assist with lead responses for FDA inspections, audits, quality assurance reviews, and monitoring visits.

Assisting with identifying compliance gaps and implementing processes for corrective action planning is required.

Maintaining standardized regulatory practices across multiple studies with multiple PIs is required.

Must be able to use a variety of electronic platforms and be knowledgeable of or willing to learn and apply FDA regulations, HSP, UAB research processes, and IRB submission processes.

Must have good project management and risk assessment skills.

Must be able to communicate effectively with staff, investigators, sponsor representatives, legal officers, and other clinical trials administrative staff.

Must possess great computer skills, have experience with Microsoft Office, be able to engage in group meetings and discussions, be able to actively work closely with others and under the leadership of Investigators and senior research coordinators in a variety of settings, and have a strong work ethic.

Must also be knowledgeable of or willing to learn UAB systems such as MURE, IRAP, Florence e-binder system, and Veeva Vault.

EEO Statement

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

311402800 Med - Pulmonary/Allergy/Critical Care

Employee Status

Regular

Shift: Day/1st Shift

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