Senior Clinical Research QA Analyst — Remote

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

Benefits offered by this job

Competitive wages

Paid holidays

Generous time off

Medical, dental, and pharmacy plans

Wellbeing program

Job summary

The University of Minnesota is seeking a QA professional to support the HRPP QA program with a focus on clinical investigator inspections, risk assessment, and regulatory compliance. This 50% appointment emphasizes on-site and remote work options and requires strong knowledge of GCP and federal regulations.

Responsibilities include conducting inspections, interpreting findings, reporting results, and mentoring staff.

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 in accord with QA program plans and assess risk across programs.
• Investigate compliance breaches; gather information, assess impact, mitigate risk and report findings.
• Evaluate investigator adherence to GCP and study procedures through on-site inspections.
• Assist in resolving issues to ensure compliance and protect research subjects.
• Review data quality and integrity via in-house CRF reviews and on-site source verification; resolve data inconsistencies.

Skills

Regulatory knowledge

Clinical research experience

IRB/HRPP familiarity

Communication skills

Education

BA/BS degree

Job description

The University of Minnesota is seeking a QA professional to support the HRPP QA program with a focus on clinical investigator inspections, risk assessment, and regulatory compliance. This 50% appointment emphasizes on-site and remote work options and requires strong knowledge of GCP and federal regulations.

Responsibilities include conducting inspections, interpreting findings, reporting results, and mentoring staff.