Research Quality Assurance Auditor

Core Job Summary

The Research Quality Assurance Auditor conducts routine and focused audits of human subject research studies for compliance with federal and local regulations, guidelines and internal policies and procedures. The Quality Assurance Auditor reports to the Director, Research Quality Assurance.

Core Job Functions

• Conducts routine and focused audits of human subject research studies in compliance with Food & Drug Administration (FDA), Good Clinical Practice (GCP), and other federal regulations, International Council for Harmonisation (ICH-GCP) guidelines and internal policies and procedures.
• Prepares written reports of observations.
• Affords assistance to study teams in creating corrective and preventive action (CAPA) plans in response to internal audits.
• Conducts CAPA implementation follow-up reviews to ensure all actions have been completed.
• Reports compliance deficiencies to RQA/OVPRS leadership and recommends appropriate corrective/preventive actions.
• Maintains awareness of new legislation or changes in regulations that may affect the University's compliance in conducting research, recommending changes to internal policies and procedures, as appropriate.
• Collaborates with internal units (e.g., HSRO, EDR/IITS-U, Privacy Office, University Compliance, etc.) to resolve research-related compliance issues.
• Assists with maintenance of QA databases, electronic audit files and metrics reporting.
• Adheres to University and unit-level policies and procedures and safeguards University assets.

  Core Qualifications

  • Education: Bachelor’s degree in Science, Health Care, or related field is required. Master’s degree preferred.
  • Certification and Licensing: Professional certification in at least one of the following areas is highly preferred: clinical research, Good Clinical Practice (GCP), research compliance, auditing.
  • Experience: Minimum 1 (preferably 2 years) of research-related experience, including research compliance, study coordination, auditing, or monitoring experience. Working knowledge of federal regulations regarding clinical research and Good Clinical Practice (GCP) is required. Any appropriate combination of relevant education and/or work experience may be considered.
  • Knowledge, Skills and Attitudes: Ability to communicate effectively in (English) both oral and written form. Ability to establish and maintain effective working relationships with leadership, physicians, and coworkers. Ability to deal professionally with all types of information including that of a confidential and sensitive nature. Ability to recognize, analyze, and solve a variety of problems. Ability to exercise sound judgment in making critical decisions. Excellent organizational skills with strong attention to detail and accuracy. Ability to manage numerous priorities effectively. Proficiency using Microsoft Office products (Microsoft Word, Excel, PowerPoint, and SharePoint) with excellent data management skills.

    Qualifications

    • Education: Bachelor’s degree in Science, Health Care, or related field is required. Master’s degree preferred.
    • Certification and Licensing: Professional certification in at least one of the following areas is highly preferred: clinical research, Good Clinical Practice (GCP), research compliance, auditing.
    • Experience: Minimum 1 (preferably 2 years) of research-related experience, including research compliance, study coordination, auditing, or monitoring experience. Working knowledge of federal regulations regarding clinical research and Good Clinical Practice (GCP) is required. Any appropriate combination of relevant education and/or work experience may be considered.
    • Knowledge, Skills and Attitudes: Ability to communicate effectively in (English) both oral and written form. Ability to establish and maintain effective working relationships with leadership, physicians, and coworkers. Ability to deal professionally with all types of information including that of a confidential and sensitive nature. Ability to recognize, analyze, and solve a variety of problems. Ability to exercise sound judgment in making critical decisions. Excellent organizational skills with strong attention to detail and accuracy. Ability to manage numerous priorities effectively. Proficiency using Microsoft Office products (Microsoft Word, Excel, PowerPoint, and SharePoint) with excellent data management skills.

    Benefits

    The University of Miami offers a comprehensive benefits package including medical, dental, vision, retirement, paid time off, and more.

    Pay

    The salary range for this position is $65,000 - $85,000 annually.

    Schedule

    The schedule for this position is full-time.

    About the Role

    The Research Quality Assurance Auditor plays a crucial role in ensuring the integrity and compliance of human subject research studies at the University of Miami. This position requires a deep understanding of regulatory requirements and a commitment to maintaining high standards of quality and safety in research practices.

    Skills

    Strong analytical and problem-solving skills are essential for this role. The ability to work independently and collaboratively with various stakeholders is also important.

    Qualifications

    • Education: Bachelor’s degree in Science, Health Care, or related field is required. Master’s degree preferred.
    • Certification and Licensing: Professional certification in at least one of the following areas is highly preferred: clinical research, Good Clinical Practice (GCP), research compliance, auditing.
    • Experience: Minimum 1 (preferably 2 years) of research-related experience, including research compliance, study coordination, auditing, or monitoring experience. Working knowledge of federal regulations regarding clinical research and Good Clinical Practice (GCP) is required. Any appropriate combination of relevant education and/or work experience may be considered.
    • Knowledge, Skills and Attitudes: Ability to communicate effectively in (English) both oral and written form. Ability to establish and maintain effective working relationships with leadership, physicians, and coworkers. Ability to deal professionally with all types of information including that of a confidential and sensitive nature. Ability to recognize, analyze, and solve a variety of problems. Ability to exercise sound judgment in making critical decisions. Excellent organizational skills with strong attention to detail and accuracy. Ability to manage numerous priorities effectively. Proficiency using Microsoft Office products (Microsoft Word, Excel, PowerPoint, and SharePoint) with excellent data management skills.

    Research Quality Assurance Auditor

    The Research Quality Assurance Auditor is responsible for ensuring the compliance and quality of human subject research studies at the University of Miami. This role involves conducting audits, preparing reports, and assisting with corrective and preventive actions.

    University of Miami

    The University of Miami is committed to providing a diverse and inclusive workplace, and is an equal opportunity employer. The university is dedicated to fostering a culture where every individual feels valued and empowered to contribute meaningfully.