Clinical Research QA Specialist

About the Job

The Minnesota Cancer Clinical Trials Network (MNCCTN) is a multi‑site cancer clinical trials network led by the Masonic Cancer Center (MCC) at the University of Minnesota (UMN). MNCCTN 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 reports to the MNCCTN Director of Operations and works closely with MNCCTN Partners, sites, investigators, study teams at 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.

The role 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, and monitors 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 toward 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.

• Quality Assurance Study Monitoring (70%)
  • Perform on‑site and remote monitoring for the 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.
  • Monitor 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.
  • Evaluate site responses to findings and ensure appropriate corrective actions are completed. Review findings for continued compliance concerns and escalates as needed.
  • Schedule and perform study start‑up, interim, and close‑out visits.
  • Communicate all queries and concerns to both the principal investigator and the research staff and provide training (e.g., Good Clinical Practices, the need for documentation of study procedures, how to obtain informed consent, etc.) when necessary.
  • Generate 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 or 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, analyze incoming data for completeness and consistency, produce quarterly and ad‑hoc reports.
  • Audit and verify the completeness and accuracy of study documentation, templates, and 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 the MNCCTN quality assurance program.
  • Participate in training and onboarding of new research staff and…