Clinical Research Regulatory Coordinator I – Entry Level

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

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