Research Quality Assurance Auditor

University of Miami•Coral Gables, FL

4d•Onsite

About The Position

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. The Research Quality Assurance Auditor conducts routine and focused audits of human subject research protocols to ensure compliance with federal and local regulations and guidelines and research site specific Standard Operating Procedures (SOPs). The Research Quality Assurance Auditor reports to the Director, Research Quality Assurance.

Requirements

Bachelor’s Degree in Science, Health Care, or related field.
Professional certification in at least one of the following areas: clinical research, research compliance, auditing.
Minimum 1 year (preferably 2 years) of work-related research experience, including research compliance or study coordination, auditing, or monitoring experience.
Working knowledge of FDA, OHRP and ICH-GCP regulations and guidelines, in regards to clinical research and Good Clinical Practice (GCP) is required.
Ability to communicate effectively in (English) both oral and written form.
Ability to maintain effective interpersonal relationships.
Ability to deal professionally with all types of information including that of a confidential nature.
Ability to exercise sound judgment in making critical decisions.
Ability to recognize, analyze, and solve a variety of problems.
Ability to lead, motivate, develop and train others.
Excellent organizational skills with strong attention to detail/accuracy.
Ability to effectively set priorities and perform a variety of tasks simultaneously.
Proficiency using Microsoft Office products (Microsoft Word, Excel, PowerPoint, and SharePoint) with excellent data management skills.

Nice To Haves

Master’s Degree preferred.
Nursing degree desirable.
One of the following certifications is desirable: RQAP-GCP, CHRC, CCRC, CCRP

Responsibilities

Conducts routine and focused audits of human subject research protocols to ensure compliance with FDA GCP and other federal regulations, ICH-GCP guidelines, and internal policies and procedures.
Conducts audits of IND/IDE multi-center studies, including external sites.
Prepares audit reports and reports of investigations/inquiries.
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.
Advises RQA leadership of deficiencies and recommends necessary corrective and preventive actions.
As requested by RQA leadership, investigates and/or conducts inquiries of laboratories and research protocols.
Assists in the preparation and presentation of educational classes to the University research community.
Monitors new legislation or changes in regulations that might affect the University’s compliance in conducting research, recommending changes to administrative policies and procedures, as appropriate.
Collaborates with internal units (e.g., Human Subjects Research Office, Privacy Office, University Compliance, etc.) to resolve research-related compliance issues.
Assists RQA leadership in the creation and maintenance of internal policies and SOPs as well as University-wide policies.
Maintains RQA related databases, electronic audit files and metrics.
Adheres to University and unit-level policies and procedures and safeguards University assets.

Benefits

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.
The mission of the University of Miami is to transform lives through education, research, innovation, and service.
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.