Summary: The Regulatory Affairs CoordinatorII possesses substantial clinical research and regulatory knowledge; is capable of independent action in the development, application and maintenance of all regulatory documentation and activities within the Cook Children's System. This person may rely upon other Senior Regulatory Affairs staff for guidance, but is capable of managing a project with highest quality throughout its lifecycle. The Regulatory Affairs Coordinator II will further develop their knowledge of regulatory guidelines through independent study and external training, as appropriate.
Bachelor's degree in appropriate field (e.g., healthcare, social or health science, etc.) and minimum 5 years relevant clinical research, pharmaceutical or regulatory experience with at least 3 years regulatory affairs experience required; or an equivalent combination of education/certification and experience from which comparable knowledge and abilities can be demonstrated.
Computer proficiency in word processing and Excel required.
Knowledge of medical terminology required.
Knowledge of principles of research and federal regulations required.
Detail-oriented with strong organizational skills.
Excellent writing and editing skills.
Good interpersonal and communication skills required.
Licensure, Registration, and/or Certification:
IRB Administration or Clinical Research certification required if used in lieu of education.