Gcp Qa Auditor Jobs (NOW HIRING)

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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 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 studiesin 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. Click here for additional information.

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