CLINICAL RESEARCH REGULATORY COORDINATOR II

at  University of Alabama at Birmingham

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

• 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.
  UAB is an Equal Opportunity/Affirmative Action Employer committed to fostering a diverse, equitable, and family-friendly environment in which all faculty and staff can excel and achieve work/life balance irrespective of race, national origin, age, genetic or family medical history, gender, faith, gender identity and expression as well as sexual orientation. UAB also encourages applications from individuals with disabilities and veterans.
  Primary Location: University
  Job Category: Clinical Research
  Organization: 311400030 DOM Research Unit
  Employee Status: Regular
  Shift: Day/1st Shift
  Work Arrangement (final schedule to be determined by the department/hiring manager): Onsite