50% Senior Clinical Research Quality Assurance Analyst

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 performed 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.

Position Duties and 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 appropriate proportion of inspections to meet program goals and comprehensively assess risk. The plans and procedures are to be developed using the program's risk-based methodology, focusing inspection efforts on those activities creating the greatest risks.
• Investigate compliance breaches. Gather relevant information, assess the 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 the area of 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 any issues in order to ensure compliance and enhance the protection of research subjects.
• Review the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Work with investigators, when appropriate, to resolve data inconsistencies.
• May review protocols, eCRFs, monitoring reports and follow-up letters, study manuals and other prepared study-related documents and templates, as requested by the QA Program and/or IRB.
• Authorized to request inspections due to data integrity concerns.
• Communicate the results of work performed, using both verbal and written skills. This will include:
  • Developing and documenting findings in a manner that allows for proper review and assessment of the risks identified and the conclusions drawn.
  • Conduct meetings with the principal investigator and study team to discuss preliminary (when applicable) and final results. Meetings with the IRB will be scheduled as necessary.
  • Drafting the initial inspection report document.

  • In consultation with the program director, use appropriate judgment in evaluating the significance of audit findings to ensure recommendations are actionable and aligned with regulations and guidance governing the protection of human research participants.

In House Inspections and Compliance Assessments (10%):

• Lead, plan, develop and conduct internal evaluations of clinical investigator compliance; collect, and analyze data from a variety of 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 lead the implementation of compliance efforts and support strategic initiatives.
• Provide advice and expert knowledge on regulatory requirements and UMN HRPP policies to IRB Committee members, IRB staff, researchers and study staff
• Attend IRB meetings to maintain consistency between the IRB review and the QA program as needed.
• Assist with external quality and regulatory reviews of the HRPP as well as collaborate with other organizations (internal and external) in support of the HRPP mission

Program Development and Compliance Results Evaluations (10%):

• Analyze and interpret policies and procedures, federal regulations, GCP compliance, guidance documents and accreditation standards for the protection of human subjects. Expert knowledge of all regulatory requirements related to the conduct of clinical research.
• 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 mentor for junior staff of the HRPP QA program.
• Assist the QA Program in 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 to be used for inspections of University units and processes. The plans and procedures are to be developed using a risk-based methodology, focusing our efforts on those activities creating the greatest risks to the institution.

Other Duties as Assigned (5%):

• Attends 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.

Flexible Work Profile
The Research and Innovation Office (RIO) and HRPP endorses a "work with flexibility" approach that offers a welcoming and flexible work environment where everyone is inspired to do their best. Work location options include working fully remote, partially remote, or entirely in the office and are based on the work of the position. Some on-site work may be necessary for certain positions, even those designated as fully remote.

This position has been designated as eligible for Flexible Work Profile Four.
Flexible Work Profile Four, Fully Remote: Only occasionally visiting the office. Typically spends four or less days per month working in the office/lab on average. Your dedicated office space will be in your remote work location.

HRPP management retains the right to modify flexible work arrangement agreements on a temporary or permanent basis for any reason at any time.

Required 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 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 exam

Knowledge, Skills and Abilities

• Ability to identify and solve problems
• Ability to apply sound judgment and take initiative in collection of 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

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 Range: $50,523.20 - $51,989.60 annually; depending on education/qualifications/experience

Time Appointment: 50% Appointment

Position Type: Faculty and P&A Staff

Please visit the Office of Human Resources website for more information regarding benefit eligibility.

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

While our salary ranges provide a framework, it is important to note that most of the time, the initial pay may not reach the maximum of the range. This approach ensures that compensation reflects the value and unique contributions of each candidate while maintaining equity within our organization. As part of our commitment to fair and equitable compensation, please be aware that the salary offered to incoming candidates will be based on their individual credentials and experience.

Applications must be submitted online. To be considered for this position, please click the Apply button and follow the instructions. You will have the opportunity to complete an online application for the position and attach a cover letter and resume or CV.

To request an accommodation during the application process, please e-mail jobcentr@umn.edu.

The University recognizes and values the importance of diversity and inclusion in enriching the employment experience of its employees and in supporting the academic mission. The University is committed to attracting and retaining employees with varying identities and backgrounds.

The University of Minnesota provides equal access to and opportunity in its programs, facilities, and employment without regard to race, color, creed, religion, national origin, gender, age, marital status, disability, public assistance status, veteran status, sexual orientation, gender identity, or gender expression. To learn more about diversity at the U: http://diversity.umn.edu

Any offer of employment is contingent upon the successful completion of a background check. Our presumption is that prospective employees are eligible to work here. Criminal convictions do not automatically disqualify finalists from employment.

This position is not eligible for H-1B visa sponsorship.

The University of Minnesota, Twin Cities (UMTC)

The University of Minnesota, Twin Cities (UMTC), is among the largest public research universities in the country, offering undergraduate, graduate, and professional students a multitude of opportunities for study and research. Located at the heart of one of the nation's most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations.

At the University of Minnesota, we are proud to be recognized by Forbes as a Best Employer for Company Culture (2026), Best Employer for Women (2023, 2025, 2026), and Best Employer by State (2022-2026). In 2026, we also received Culture Excellence & Industry Awards recognition for employee appreciation and work-life flexibility.