Remote Clinical Research Regulatory Coordinator II

University of Alabama at Birmingham; Birmingham (AL); Hybrid; USD 48,000 - 77,000; Full time

Job summary

University of Alabama at Birmingham (UAB) is seeking a Clinical Research Regulatory Coordinator II to prepare, submit, and manage regulatory documentation for IRB submissions, INDs, and IDEs. This role entails maintaining consent forms, protocols, CVs, licenses, recruitment materials, safety reports, and submission forms.

Responsibilities include drafting informed consents, preparing FDA applications for INDs/IDEs, and providing regulatory guidance to the team.

Qualifications

• Bachelor's degree in a related field and three (3) years of related experience required.
• Work experience may substitute for education requirement.

Responsibilities

• Prepare, submit, and assist with multiple levels of research documentation (IRB submissions, educational materials, reports, grant renewal reports, and study forms).
• Maintain regulatory documentation including consent forms, protocols, 1572s, CVs, licenses, investigator brochures, recruitment materials, safety reports, and submission forms.
• Draft informed consents.
• Prepare and maintain FDA applications for INDs and IDEs.
• Assist in drafting compliant advertisements.
• Serve as resource person or consultant within area of regulatory expertise.

Skills

Regulatory knowledge

IRB submissions

IND/IDE familiarity

Communication

Education

Bachelor's degree

Job description

University of Alabama at Birmingham (UAB) is seeking a Clinical Research Regulatory Coordinator II to prepare, submit, and manage regulatory documentation for IRB submissions, INDs, and IDEs. This role entails maintaining consent forms, protocols, CVs, licenses, recruitment materials, safety reports, and submission forms.

Responsibilities include drafting informed consents, preparing FDA applications for INDs/IDEs, and providing regulatory guidance to the team.