Clinical Research QA Specialist 3

The Minnesota Cancer Clinical Trials Network (MNCCTN) is a multi-site cancer clinical trials network. The network, led by the Masonic Cancer Center (MCC) at the University of Minnesota (UMN), brings cancer clinical trials from the Masonic Cancer Center, Mayo Clinic Cancer Center, Hormel Institute and partner institutions to community sites across the state. As a growing program, MNCCTN offers qualified candidates the opportunity to join a team that is shaping the direction and implementation of cancer clinical research across the state.

The CRA and Quality Specialist is a member of the network's coordinating center and reports to MNCCTN's Director of Operations and works closely with MNCCTN Partners and sites, investigators, and study teams the UMN and Mayo Clinic Cancer Center, UMN Masonic Cancer Center's CTO, CTSI, and other research groups or organizations. As a key member of the MNCCTN Portfolio team, the CRA and Quality Specialist's primary responsibility is to develop and execute quality assurance and monitoring strategies during clinical studies/trials to ensure compliance with regulations, applicable standards, and corporate policies. Evaluates overall risk levels and audits research activities for conformance to requirements throughout the study. Develops and assesses the effectiveness of corrective and preventative actions. monitoring of the network's portfolio of multi-site cancer clinical trials. Using their knowledge of clinical research, they provide technical expertise and overall guidance for the network's quality assurance program. The CRA and Quality Specialist also participates in the development of the network's processes and policies with a focus towards sustainability and growth.

A successful applicant will be highly organized, able to oversee multiple projects in various stages of development, and work collaboratively with a wide variety of internal and external stakeholders.

RESPONSIBILITIES:
Quality Assurance Study Monitoring - 70%
* Perform on-site and remote monitoring for MNCCTN managed portfolio of multi-site cancer clinical trials in accordance with the QA and study specific monitoring and data management plan. Includes review of participant consent, study participant medical record, EDC, source documentation, regulatory documentation, and pharmacy accountability.
* Responsible for monitoring to the standards of the FDA Code of Federal Regulations, ICH GCP guidelines, NIH, the Human Subjects Protection Program and applicable HIPAA regulations.
* Evaluate risk levels and analyze compliance trends as defined by the MNCCTN Quality Assurance Plan.
* Evaluates site responses to findings and ensures that appropriate corrective actions are completed. Reviews findings for continued compliance concerns and escalates as needed.
* Responsible for scheduling and performing study start-up, interim and closeout visits.
* Communicates all queries and concerns to both the principal investigator and the research staff and provides training (e.g. Good Clinical Practices, the need for documentation of study procedures, how to obtain informed consent, etc.) when necessary.
* Generates visits and close out reports in a timely manner.

Portfolio Team Operations - 15%
* Participate in study review activities to assess protocols for multi-site implementation appropriateness and success.
* Lead / co-lead network calls, meetings, and training initiatives to provide both study-specific and general best practice guidance on QA topics and findings to site staff and study team members.
* Lead and collaborate on quality and regulatory reporting efforts for internal and external partners. Prepare data requests for internal and external partners, analyze incoming data for completeness and consistency. Produce quarterly reports and ad hoc reports based on latest data and disseminate as appropriate.
* Audit and verify the completeness and accuracy of study documentation, templates, version control in OnCore and Florence eBinders.

Quality Assurance Leadership and Strategic Roadmap - 10%
* Accomplish quality assurance program goals in collaboration with MNCCTN Leadership.
* Develop, execute, and maintain the MNCCTN Quality Assurance plan and associated guidance documents and procedures.
* Serve as an ambassador for MNCCTN quality assurance program.
* Participant in training and onboarding of new research staff and provide ongoing mentorship for current portfolio and network staff.
* Lead quality assurance educational events for MNCCTN staff and partner sites.

Professional Development - 5%
* Remain informed of emerging quality assurance standards at the state and federal level including relevant clinical research regulations and guidelines
* Engage in professional development opportunities in relevant technologies and best practices

All required qualifications must be documented on application materials.

Required Qualifications:
* BA/BS in health, public health, or biomedical disciplines plus at least 4 of clinical research experience or advanced degree plus 2 years of clinical research experience, or a combination of related education and work experience to equal nine years
* Comprehensive working knowledge of best practices and regulations governing clinical research activity (GCP, FDA regulations, and ICH guidelines)
* Experience monitoring clinical trials or direct experience and knowledge from working closely with clinical trial monitors, source verification and corrective action plans.
* Ability to work with research staff of all experience levels including coordinators and investigators
* Demonstrated ability to work effectively on multiple projects at various stages with competing demands
* Incumbent must exercise judgment, diplomacy, and discretion in all interactions and operate under the highest ethical standards at all times
* Experience with Electronic Data Capture and Medical Records review, general survey collection systems including Qualtrics, REDCap, or Medidata Rave
* Periodic travel within Minnesota for site visits required. Must have a valid driver's license.

Preferred Qualifications:
* Experience with investigator-initiated human subjects clinical research in an oncology setting
* Experience working as a research coordinator in a clinical setting
* Familiarity with Clinical Trial Management Systems and Regulatory e-tech (e.g. OnCore, eFlorence)
* Clinical Research professional certification (ACRP, SoCRA)

The Masonic Cancer Center (MCC) is an NCI-designated Comprehensive Cancer Center dedicated to cancer research, education, and patient care for the citizens of Minnesota and the surrounding region. Since the time of the first award in 1997, there has been consistent growth of the membership and research base, enabling our center to further advance our knowledge and enhance care for our catchment area. We are driven to be the choice academic healthcare environment for patients, clinicians, scientists and students who seek exceptional, compassionate, precision cancer therapy; innovative clinical trials and prevention programs; cutting-edge research opportunities; and outstanding advanced education.

Pay Range: $91,000 - $110,000; depending on education/qualifications/experience

Time Appointment: 100% Appointment

Position Type: Civil-Service & Non-Faculty Labor Represented 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 and degree-seeking programs supported by the Regents Tuition Benefit Program
• 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
• Employee Transit Pass with free or reduced rates in the Twin Cities metro area

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 be given the opportunity to complete an online application for the position and attach a cover letter and resume.

Additional documents may be attached after application by accessing your "My Job Applications" page and uploading documents in the "My Cover Letters and Attachments" section.

To request an accommodation during the application process, please e-mail employ@umn.edu or call (612) 624-8647.

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.

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), and Best Employer by State (2022-2026). In 2026, we also received Culture Excellence & Industry Awards recognition for employee appreciation and work-life flexibility.