50% Senior Clinical Research Quality Assurance Analyst

About the role

This 50% position will assist in the ongoing conduct of the U of M HRPP QA program, evaluating clinical investigator performance and compliance with policies and procedures, Good Clinical Practice, and applicable regulatory requirements. The primary purpose of the work is to conduct clinical trial inspections, perform risk assessments, analyze trends including root cause, and report and disseminate information to key stakeholders to enhance the protections of human research participants at the University of Minnesota, Fairview Hospitals, Gillette, and affiliated clinics.

Responsibilities

• Quality Assurance Inspections of Investigator Compliance (75%):
  • Plan, develop, and conduct on-site inspections of clinical research in accord with QA program plans, including execution of an appropriate proportion of inspections to meet program goals and comprehensively assess risk.
  • Develop plans and procedures using the program’s risk-based methodology, focusing inspection efforts on activities creating the greatest risks.
  • Investigate compliance breaches: gather relevant information, assess impact to the University and affiliates, determine steps to mitigate risk, and report findings.
  • Communicate regulatory changes, update procedures according to best practice, and act as a resource to colleagues and researchers in research compliance.
  • Evaluate clinical investigator adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site inspections.
  • Assist in resolving issues to ensure compliance and enhance the protection of research subjects.
  • Review the quality and integrity of clinical data through in-house review of electronic CRF data and on-site source verification. Work with investigators to resolve data inconsistencies.
  • Review protocols, eCRFs, monitoring reports, follow-up letters, study manuals, and other study-related documents as requested by the QA Program and/or IRB.
  • Authorized to request inspections due to data integrity concerns.
  • Communicate results of work performed using both verbal and written skills, including:
    • Developing and documenting findings to allow proper review and assessment of risks identified.
    • Conducting meetings with the principal investigator and study team to discuss preliminary and final results.
    • Scheduling meetings with the IRB as necessary.
    • Drafting the initial inspection report document.
  • In consultation with the program director, evaluate the significance of audit findings to ensure recommendations are actionable and aligned with regulations governing human research protections.
• In-House Inspections and Compliance Assessments (10%):
  • Lead, plan, develop, and conduct internal evaluations of clinical investigator compliance; collect and analyze data from various sources and teams.
  • Develop comprehensive reports of results for dissemination to internal and external compliance entities.
  • Work collaboratively with researchers and HRPP staff to develop and implement compliance efforts and support strategic initiatives.
  • Provide advice and expert knowledge on regulatory requirements and UMN HRPP policies to IRB Committee members, IRPP staff, researchers, and study staff.
  • Attend IRB meetings to maintain consistency between IRB review and the QA program as needed.
  • Assist with external quality and regulatory reviews of the HRPP and collaborate with other organizations in support of the HRPP mission.
• Program Development and Compliance Results Evaluations (10%):
  • Analyze and interpret policies, procedures, federal regulations, GCP compliance, guidance documents, and accreditation standards for the protection of human subjects.
  • Work with QA staff to analyze overall findings for trends and key process failures, and contribute to the annual report of the program.
  • Lead and manage the creation, development, and maintenance of policies, procedures, and tools related to clinical inspections.
  • Initiate and participate in cross-functional problem-solving projects; establish and maintain records of compliance activities.
  • Serve as a mentor for junior staff of the HRPP QA program.
  • Assist the QA Program in the annual evaluation of related program activities and risk stratification for study inspection selection.
  • In collaboration with program leadership, plan and develop the overall clinical inspection plan and specific tests and procedures using a risk-based methodology.
• Other Duties as Assigned (5%):
  • Attend study-related and departmental meetings as required.
  • Maintain appropriate credentialing.
  • Maintain expert knowledge of clinical inspection/auditing techniques, requirements, and guidance.
  • Collaborate with internal compliance functions to enhance research compliance at the University of Minnesota.
  • Conduct follow-up work to determine the status of prior recommendations made to management when requested.
  • Complete training and other activities to maintain and enhance professional skills, credentials, and abilities.
  • Serve as a resource for other QA staff auditors.

Schedule

This position has been designated as eligible for Flexible Work Profile Four, Fully Remote: only occasionally visiting the office, typically spending four or fewer days per month working in the office/lab on average.

Requirements

• 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 by the Association of Clinical Research Professionals).

Preferred Qualifications

• Seven or more years of experience working in the clinical research industry.
• Good Clinical Practice monitoring and/or quality assurance experience.
• Clinical Research Associate certification from the Association of Clinical Research Professionals.
• RA credentialing or eligibility to sit for the exam.

Skills

• Ability to identify and solve problems.
• Ability to apply sound judgment and take initiative in collecting information from a wide variety of sources.
• Knowledge of inspection and quality control methods, techniques, and documentation.
• Ability to work with complex or diverse information and data.
• Excellent organizational skills, excellent oral and written communication skills.

About the department

The Human Research Protection Program processes IRB submissions, supports independent research review committees, and assists the executive committees comprising chairs and vice-chairs from other panels.

Pay

Pay Range: $50,523.20 - $51,989.60 annually, depending on education, qualifications, and experience. This is a 50% appointment.

Benefits

The University offers a comprehensive benefits package that includes:

• Competitive wages, paid holidays, and generous time off.
• Continuous learning opportunities through professional training.
• Medical, dental, and pharmacy plans.
• Healthcare and dependent care flexible spending accounts.
• University HSA contributions.
• Disability and life insurance.
• Employee wellbeing program.
• Retirement plans.
• Financial counseling services.
• Employee Assistance Program with eight sessions of counseling at no cost.