Clinical Research Quality Specialist 2

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Clinical Research Quality Specialist 2

The University of Miami/UHealth department of SCCC has an exciting opportunity for a Full Time Clinical Research Quality Specialist 2 to work Hybrid in Miami, FL.

The Clinical Research Quality Specialist 2 independently performs quality control reviews and contributes to clinical research quality improvement initiatives through analysis of compliance trends and reporting. The position provides structured support for quality assurance activities and follow-up actions.

• Independently performs quality control reviews of clinical research study documentation and data for accuracy, completeness, consistency, and compliance.
• Identifies patterns, trends, and recurring issues within quality findings and compliance metrics.
• Prepares reports summarizing quality control findings, trends, observations, and opportunities for process improvement.
• Participates in quality improvement initiatives and supports implementation and evaluation of improvement activities.
• Develops and maintains tracking tools for compliance metrics, documentation status, and assigned follow-up items.
• Performs self-audits of deliverables to ensure accuracy, consistency, and alignment with established procedures.
• Provides documentation and data to support quality assurance reviews and tracks completion of follow-up items identified by quality assurance.
• Communicates findings and collaborates with research teams and stakeholders to support timely resolution of identified issues.
• Applies applicable clinical research requirements, including ICH-GCP, FDA requirements, IRB standards, and University policies, and Florida law.
• 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

• Bachelor’s degree in relevant field required
• Minimum 2 years of relevant experience required

Knowledge, Skills and Attitudes

• Learning Agility: Ability to learn new procedures, technologies, and protocols, and adapt to changing priorities and work demands.
• Teamwork: Ability to work collaboratively with others and contribute to a team environment.
• Technical Proficiency: Skilled in using office software, technology, and relevant computer applications.
• Communication: Strong and clear written and verbal communication skills for interacting with colleagues and stakeholders

The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.

UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.

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

About Us

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

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.

Transforming Lives

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.