Job #: 1395
Title: Research Compliance Auditor
Momentum is looking for a Research Compliance Auditor.
The Research Compliance Auditor develops and implements the research audit plan as an element under the Research Administration (RA) office.
The Research Compliance Auditor performs audits of research projects throughout the health care delivery system to ensure compliance with federal and state law and regulation and the institutional policies and procedures relating to the conduct of human subjects research.
- Participates in and provides training assistance on the research conduct process according to the Operating Procedure 180-9.
- Maintains current knowledge of applicable federal and state laws and accreditation standards related to research, GCP, the protection of human subjects and OP 180-9, with the ability to exercise applicability across the system.
- Conducts audits to ensure compliance with Operating Procedure 180-9, sponsor SOPs, GCP and applicable federal and state laws; develops, executes and maintains audit schedules.
- Develops audit reports for review by the RA Director, IRB representatives, PI and study team personnel; trends, collects and reports audit findings in writing and in-person to the study team.
- Ensures that the implemented research audit program is appropriate in scope, that identified issues are corrected and that all investigators and their staff are educated.
- Develops an annual audit plan and determines protocols to audit based on identified risk areas or operational requests.
- Works with the investigator and study team to identify root causes and implements corrective and preventative action plans for identified areas of non-compliance.
- Assists in the preparation for external audits by regulatory agencies or sponsors.
- Assists the Research Administration office with additional tasks and projects, as needed.