The Clinical Research Regulatory Coordinator II will prepare, submit, and assist with multiple levels of clinical research documentation for the Dermatology Clinical Research Unit.

General Responsibilities

To prepare, submit, and assist with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).
To maintain regulatory documentation including consent forms, protocols, 1572s, CVs, licenses, investigator brochures, recruitment materials, safety reports, and submission forms.
To draft informed consents.
To prepare and maintain FDA applications for Investigational New Drugs (INDs) and Investigational Device Exemptions (IDEs).
To assist in drafting compliant advertisements.
To serve as resource person or act as consultant within area of regulatory expertise.
Performs other duties as assigned.

Annual Salary Range: $47,665 - $77,455

Qualifications

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

Preferences

IRB clinical research experience.

Primary Location

: University

Job Category

: Clinical Research

Organization

: 311150000 Dermatology

Employee Status

: Regular

Shift: Day/1st Shift

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

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