CLINICAL RESEARCH REGULATORY COORDINATOR II

1 week ago

Birmingham, AL, United States UAB NOVA RENT Full time

The University of Alabama at Birmingham (UAB), DOM Research Unit is seeking a Clinical Research Regulatory Coordinator II. This position will support the DOM Clinical Research Enterprise and its shared services.

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
  • Previous UAB experience strongly preferred.

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.

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