Summary: The IRB Compliance & Quality Assurance Specialist isresponsible for assisting with achieving and maintaining accreditation throughthe Association for the Accreditation of Human Research Protection Programs(AAHRPP) and developing continuous quality improvement initiatives that areconsistent with the accreditation standards. This position is also responsiblefor conduct of the post-approval research compliance program.
Bachelor's degree required in nursing, science, or healthrelated management field.
Minimum of 5 years of research-related, IRB, or researchcompliance experience required.
Knowledge of Federal regulations related to human subjectprotections, e.g., DHHS, FDA, as well as Good Clinical Practice guidelines (asrelated to research), HIPAA, etc.
Must have strong organizational, critical thinking, problemsolving, and writing skills.
Excellent attention to detail and must be able to completemultiple tasks independently as well as with direction.
Must have excellent project management skills.
Must possess strong verbal, written and interpersonalcommunication skills.
Able to communicate comfortably with physicianinvestigators, research personnel, and officials from otherdepartments.
Basic computer skills including Microsoft Word, MicrosoftOffice: Excel, Access, PowerPoint, and ability to work in various, otherinternet-based software applications.
Certified in Healthcare Research Compliance or is eligibleto test for certification exam within one year of hire.