Clinical Research Quality Specialist

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.

• 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.

• 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

• 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