Academic Research, Administrative Policies, Analysis Skills, Audit Metrics, Auditing, Clinical Research, Communication Skills, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Data Management, Database Administration, Detail Oriented, English Language, Establish Priorities, FDA (Food and Drug Administration), Federal Laws and Regulations, File Audits, GCP (Good Clinical Practices), Health Science, Healthcare, ICH Regulations, IDE (Integrated Development Environment), Internal Audit, Interpersonal Skills, Leadership, Licensing, Maintain Compliance, Microsoft Excel, Microsoft Office, Microsoft PowerPoint, Microsoft Product Family, Microsoft SharePoint, Microsoft Word, Multitasking, Nursing, Organizational Skills, Presentation/Verbal Skills, Quality Assurance, Regulations, Reporting Skills, Research Laboratory, Research Protocols, Research Skills, Standard Operating Procedures (SOP), Training/Teaching, University/School Policies
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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.
CORE JOB SUMMARY
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.
CORE JOB FUNCTIONS
- 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.
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
Education:
Bachelor's Degree in Science, Health Care, or related field. Master's Degree preferred. Nursing degree desirable.
Certification and Licensing:
Professional certification in at least one of the following areas: clinical research, research compliance, auditing. One of the following certifications is desirable: RQAP-GCP, CHRC, CCRC, CCRP
Experience:
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. Any appropriate combination of relevant education and/or work experience may be considered.
Knowledge, Skills and Attitudes:
- 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.
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. Click here for additional information.
Job Status:
Full time
Employee Type:
Staff