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Sr Quality Assurance Assoc 1

Company: University of Minnesota
Location: Saint Paul
Posted on: March 17, 2023

Job Description:

Apply for Job Job ID 354585
Location Twin Cities
Job Family Research-Support
Full/Part Time Full-Time
Regular/Temporary Regular
Job Code 9742S1
Employee Class Acad Prof and Admin
Add to Favorite Jobs Email this Job About the Job

Senior Quality Assurance Associate I - Auditor
Res Project Specialist 1 (9742S1)

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

All required qualifications must be documented on application materials. 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.
About the Department

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.

Working at the University 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 website for more information regarding benefits.
    How To Apply

    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 or call (612) 624-UOHR (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:
    Employment Requirements

    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.

    Please note: All employees at the University of Minnesota are required to comply with the University's Administrative Policy: COVID-19 Vaccination and Safety Protocol by either providing proof of being fully vaccinated on their first day of employment, or complete a request for an exemption for medical exemption or religious reasons. To learn more please visit:
    About the U of M

    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.

Keywords: University of Minnesota, St. Paul , Sr Quality Assurance Assoc 1, Other , Saint Paul, Minnesota

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