Clinical Research Quality Specialist 2
University of Miami
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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
- Bachelors 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 Floridas 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. Were the challenge youve 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 timeEmployee Type:
StaffRequired Experience:
IC
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