Senior Quality Assurance Associate at University of Minnesota

We need one to Develop organizational metrics of audit finding reports for management as requested.

Required Qualifications:

• BA/BS degree and at least six years of relevant experience.
• Quality auditing or monitoring experience.
• Knowledge of clinical research regulations (FDA, GCP).
• Experience leading teams and delegating or assigning work tasks.
• Strong organizational skills, including evidence of ability to multi-task.
• Excellent verbal and written communication skills.
• Experience working with diverse populations.

Preferred Qualifications:

• Prior experience within academic research, sponsor, or CRO settings (Clinical Research Associate, Clinical Trial Managers, CRAs, CRCs or Clinical Trial Assistants).
• Experience with clinical and/or translational research.
• Experience with regulatory aspects (e.g. IRB and FDA) of conducting clinical research.
• Auditing certification.
• Benefits of working at the University

Description

Utilizes extensive knowledge of research regulations to evaluate the proper conduct of complex research studies. Ensures compliance with institutional policies and federal regulations as they affect clinical research. Identifies trends, areas of risk, and provides overall recommendations for improvement in compliance, clinical outcomes, and mitigation of risk to the department.

Auditing and Quality Control 80%

Develops, executes, and maintains audit schedules according to the needs of the Masonic Cancer Center (MCC) Clinical Trials Office (CTO) and Data and Safety Monitoring Plan.

• Interprets regulations and guidance documents governing FDA, OHRP, ICH/GCP and applies the interpretation to the audit plan.
• Provides timely feedback by means of the audit report and ensures timely completion of all audit related activities.
• Tracks, collects, and reports responses and provides assistance in creating corrective and preventative action plans.
• Evaluates the potential risk of compliance deficiencies related to audit outcomes.
• Assists in the management of external audits by regulatory agencies or external sponsors.
• Develops organizational metrics of audit finding reports for management as requested.
• Reviews CAPA plans and audit responses for adequacy.
• QA Department Leadership 10%
• Works with the QA Director to collaborate on screening, interviewing, hiring, orientation and onboarding of new employees.
• Participates in the creation of quality/compliance training programs for the CTO and assists with the delivery of training programs.
• Carries out quality improvement initiatives within the CTO.
• Research Conduct Review and Compliance 10%

Utilizes extensive knowledge of Code of Federal Regulations, Good Clinical Practice (GCP) guidelines, National Institutes of Health policies specific to the NCI, as well as institutional policies, and applies them to the design, conduct, data collection and entry, data analysis and reporting of study results

• Actively participates in University of Minnesota clinical research committees, such as the OnCore Service Group and CTMS Implementation Team
• This position is 100% remote and out of state candidates are welcomed to apply.
• All required qualifications must be documented on application materials.
• At the University of Minnesota, you’ll find a flexible work environment and supportive colleagues who are interested in lifelong learning. We prioritize work-life balance, allowing you to invest in the future of your career and in your life outside of work.
• The University also offers a comprehensive benefits package that includes:
• Competitive wages, paid holidays, and generous time off
• Continuous learning opportunities through professional training and degree-seeking programs supported by the Regents Scholarship
• Low-cost medical, dental, and pharmacy plans
• Healthcare and dependent care flexible spending accounts
• University HSA contributions
• Disability and employer-paid life insurance
• Employee wellbeing program
• Excellent retirement plans with employer contribution
• Public Service Loan Forgiveness (PSLF) opportunity
• Financial counseling services
• Employee Assistance Program with eight sessions of counseling at no cost
• Please visit the Office of Human Resources websitefor more information regarding benefits.

Job Type: Full-time

Pay: $90,000.00 - $100,000.00 per year

Benefits:

• Dental insurance
• Employee assistance program
• Health insurance
• Paid time off
• Parental leave
• Retirement plan