Quality Assurance Auditor

University of Miami•Miami, FL

2d•Onsite

About The Position

The University of Miami/UHealth Department of Neurology is hiring a Quality Assurance Auditor to conduct routine and focused audits of human-subject research protocols. The role evaluates compliance with federal and local regulations and guidelines, as well as research-site standard operating procedures. The auditor advises institutional officials of deficiencies, recommends corrective actions, and follows up to confirm that actions are implemented. The position supports regulatory compliance and quality assurance activities for the Brain Endowment Bank in alignment with NIH contract requirements. Working with the Brain Bank Executive Director, Operational Committee, Research Laboratory Manager, and other stakeholders, the auditor supports compliant biospecimen management and continuous improvement of the Quality Management Plan and Standard Operating Procedures. The role conducts quarterly internal audits and serves as the external auditor for the biennial audit process.

Requirements

Bachelor’s degree in a relevant field.
At least 1 year of relevant experience.
Ability to learn new procedures, technologies, and protocols and adapt to changing priorities and work demands.
Ability to work collaboratively and contribute to a team environment.
Proficiency with office software, technology, and relevant computer applications.
Strong written and verbal communication skills for interacting with colleagues and stakeholders.

Responsibilities

Conduct routine and focused audits of human-subject research protocols and inquiries of laboratory and research protocols.
Identify compliance deficiencies, recommend corrective actions, and follow up to verify implementation.
Prepare reports of investigations and inquiries for internal or external use.
Assist with preparing and presenting educational programs for the University research community.
Monitor new legislation and regulatory changes that may affect research compliance and recommend updates to administrative policies and procedures.
Assist in creating and maintaining internal policies, standard operating procedures, and University-wide research compliance policies.
Maintain quality assurance databases and electronic and paper audit files.
Support regulatory compliance and quality assurance activities for the Brain Endowment Bank in alignment with NIH contract requirements.
Collaborate with the Brain Bank Executive Director and Operational Committee to support compliance with regulatory and contractual requirements, including oversight of compliant biospecimen management practices.
Partner with the Brain Endowment Bank Executive Director and Research Laboratory Manager to review and update the Quality Management Plan and Standard Operating Procedures in support of continuous improvement and compliance with NCI best practices and applicable regulations.
Conduct quarterly internal audits and serve as the external auditor for the biennial audit process.
Oversee quality assurance activities, including reviews of procedures and outcomes and investigations of nonconforming brain/tissue products and processes.
Collaborate with the Executive Director to report quarterly and biennial audit results and routine evaluations of Quality Management Plan and Standard Operating Procedure effectiveness to the Contracting Officer’s Representative.
Adhere to University and unit-level policies and procedures and safeguard University assets.
Perform additional duties or responsibilities as necessary.