Audit Consultant

1 week ago

Salisbury, United States CareerBuilder Full time

The candidate may complete the audit report and generate remediation suggestions outside of the listed hours (0800-1630).
Remediation consultation will occur onsite during business hours with the appropriate parties in the department of Research & Academic Affairs and Pharmacy Service.
TECHNICAL REQUIREMENTS:
Experience with gap assessment as it relates to research, FDA regulations,
Knowledge on Good Clinical Practices, Good Laboratory Practices, Human Subject Protection, and Institutional Review Boards,
Experience with Food and Drug Administration policy and procedures sufficient to evaluate research records, conduct patient tracers to follow the custody, control, and documentation of the research study and study drug,
Ability to simulate onsite Food and Drug Administration audit inspection,
Provide in depth remediation strategies that prepare the facility for Food and Drug Administration audit inspection,
Ability to perform audit in person and/or virtually.

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