Clinical Research Regulatory Specialist II

UAB; University (FL); Híbrido; USD 48.000 - 62.000; Jornada completa

Descripción de la vacante

The University of Alabama at Birmingham (UAB) seeks a Clinical Research Regulatory Coordinator II in the Med – Pulmonary/Allergy/Critical Care department.

Responsibilities include preparing and submitting IRB documents, maintaining regulatory binders and licensures, drafting informed consents, and ensuring compliance with ICH-GCP, FDA, and HIPAA across investigations. This role supports sponsors, investigators, and leadership with regulatory expertise in a hybrid work setting.

Formación

• Bachelor’s degree in a related field and three years of related experience required.
• Work experience may substitute for education requirement.

Responsabilidades

• Prepare, submit, maintain, and track IRB applications, CDAs, MTAs, DUAs, amendments, and other regulatory documents.
• Prepare for and participate in calls and meetings, and participate in site visits with sponsors.
• Prepare for, collect, and maintain documents for sponsor site visits.
• Clerical duties (scan, fax, route documents, etc.).
• Maintain regulatory binders and licensures for clinicians.
• Conduct QA audits for regulatory files.
• Use electronic databases necessary for operations.
• Performs other duties as assigned.

Conocimientos

Regulatory knowledge

Project management

Communication

FDA regulations

HIPAA

Educación

Bachelor’s degree in related field

Herramientas

MURE

IRAP

Florence e-binder

Veeva Vault

Descripción del empleo

The University of Alabama at Birmingham (UAB) seeks a Clinical Research Regulatory Coordinator II in the Med – Pulmonary/Allergy/Critical Care department.

Responsibilities include preparing and submitting IRB documents, maintaining regulatory binders and licensures, drafting informed consents, and ensuring compliance with ICH-GCP, FDA, and HIPAA across investigations. This role supports sponsors, investigators, and leadership with regulatory expertise in a hybrid work setting.