Remote Clinical QA Analyst — Research Compliance

University of Minnesota; Minneapolis (MN); On-site; USD 51,000 - 52,000; Part time

Benefits offered by this job

Flexible work profile

Remote work options

Job summary

The University of Minnesota is seeking a 50% time Quality Assurance Inspector to support the HRPP QA program. The role focuses on conducting clinical investigator inspections, risk assessments, and reporting findings to safeguard human research participants across the U of M Health system.

Responsibilities include on-site inspections, review of study documents, and collaboration with IRB and HRPP staff. Flexible work arrangements are available, including remote options and hybrid scheduling.

Qualifications

• BA/BS degree plus at least six years of experience in the clinical research industry.
• At least three years of experience working for an industry sponsor or contract research organization.
• Working knowledge of federal regulations for human subjects research.
• Eligible to sit for Clinical Research Associate exam (if not already certified)

Responsibilities

• Plan, develop and conduct on-site inspections of clinical research per QA plans with risk-based methodology.
• Investigate compliance breaches; assess impact and report findings; update procedures as needed.
• Evaluate investigator adherence to GCP and study procedures during inspections.
• Review data quality via in-house CRF review and on-site source verification; resolve inconsistencies.
• Attend IRB meetings to ensure consistency between IRB review and QA program.

Skills

Problem solving

Regulatory knowledge

Communication skills

Attention to detail

Education

BA/BS degree in a scientific/clinical field

Job description

The University of Minnesota is seeking a 50% time Quality Assurance Inspector to support the HRPP QA program. The role focuses on conducting clinical investigator inspections, risk assessments, and reporting findings to safeguard human research participants across the U of M Health system.

Responsibilities include on-site inspections, review of study documents, and collaboration with IRB and HRPP staff. Flexible work arrangements are available, including remote options and hybrid scheduling.