Research Quality Assurance Auditor

University of Miami; United States; On-site; USD 70,000 - 100,000; Full time

Job summary

The University of Miami seeks a Research Quality Assurance Auditor to conduct audits of human subject research in line with FDA, GCP and ICH-GCP standards. You will prepare reports, assist with CAPA plans, and track corrective actions while collaborating across internal units to resolve compliance issues.

Strong knowledge of federal research regulations and excellent communication are essential, as is attention to detail and data management. This role supports OVPRS and QA initiatives.

Qualifications

• Bachelor’s degree in science, health care or related field is required; Master’s preferred.
• Professional certification in clinical research, GCP, research compliance or auditing is highly preferred.
• 1–2 years of research-related experience, including compliance, coordination, auditing or monitoring.
• Working knowledge of federal regulations regarding clinical research and GCP is required.

Responsibilities

• Conduct routine and focused audits of human subject research studies in compliance with FDA, GCP, ICH-GCP, and internal policies.
• Prepare written reports of observations and recommend corrective actions.
• Assist study teams in creating CAPA plans and follow up on CAPA implementation.
• Monitor regulatory changes and advise on policy updates to ensure ongoing compliance.
• Collaborate with HSRO, Privacy Office, Compliance, and other units to resolve issues.
• Maintain QA databases, audit files and metrics reporting.
• Communicate findings clearly to leadership and stakeholders.
• Adhere to University policies and safeguard institutional assets.

Skills

Auditing

Regulatory compliance

Communication skills

Data management

CAPA implementation

Microsoft Office

Education

Bachelor's degree in Science/Health Care or related field

Tools

Microsoft Office Suite

SharePoint

Job description

CORE JOB SUMMARY

The Research Quality Assurance (RQA) team within the Office of the Vice Provost for Research & Scholarship (OVPRS) has an exciting job opportunity for a Research Quality Assurance Auditor to work at the University of Miami.

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.
• Assists 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.
• Monitors 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.
• This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.

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.

The University of Miami is recognized as one of the nation’s premier research institutions and academic health systems and is among the largest employers in South Florida. With more than 20,000 faculty and staff, the University is committed to excellence and guided by a mission to positively impact the lives of students, patients, and communities locally and globally. We are dedicated to fostering a culture where every individual feels valued and empowered to contribute meaningfully. United by shared values, the University community works together to build an environment defined by purpose, collaboration, and service.

The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.

Job Status: Full time Employee Type: Staff

Visit welcome.miami.edu/about-um to learn more about our points of pride.

We are a vibrant and diverse academic and healthcare community, the University of Miami and the University of Miami Health System ("UHealth") have rapidly progressed to become one of the nation’s top research universities and academic medical centers in the nation. The University comprises 12 schools and colleges serving undergraduate and graduate students in more than 350 majors and programs. The University ranks No. 55 on U.S. News & World Report’s 2022 Best Colleges list and ranked No. 49 in the 2022 Wall Street Journal/Times Higher Education College Rankings. Bascom Palmer Eye Institute is ranked the #1 eye hospital in the USA and offers some of the nation’s premiere eye doctors to treat every eye condition for adults. Sylvester Comprehensive Cancer, part of the Miller School of Medicine, received the prestigious National Cancer Institute designation in 2019. The University of Miami and UHealth have also ranked among the Forbes Best Employers and Best Employers for Women on several occasions, most recently in 2022. With more than 17,000 faculty and staff, the University strives for excellence, and is driven by a powerful mission to transform and impact the lives of its students, patients, members of the community, and people across the globe.

The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.