Manager, Clinical Research Monitoring

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The Department of Executive Dean For Research is currently seeking a full time Manager, Clinical Research Monitoring to work in Miami. The Manager, Clinical Research Monitoring oversees a team of University of Miami clinical research monitors for investigational site monitoring of clinical trials. This role ensures training and mentoring of all clinical research monitors.

CORE JOB FUNCTIONS  

• Oversees a team providing regulatory support for clinical research studies supported by the department. 

• Identifies study issues and implements solutions, including identifying and involving the appropriate decision-makers. 

• Anticipates regulatory needs and implements tools for effective study management.   

• Assists in creation and management of reports. 

• Facilitates the development of site training documentation and materials.  

• Assists in the creation or revision and maintenance of standard operating procedures and work instructions. 

• Contributes to the development and writing of protocols and other study documents for clinical research studies.  

• Monitors new legislation or changes in regulations that might affect the University's compliance in conducting research, provides guidance and recommends changes to administrative policies and procedures. 

•  Maintains records of regulatory activities, and prepares reports, responses, and follow-up activities. 

• Provides expert consultation on regulatory issues to research sites and investigators.  

• Advises appropriate institutional officials of deficiencies and recommends necessary corrective actions, with follow-up to ensure that needed actions have been implemented. 

• Assists with internal and external audit preparations.  

• Remains in compliance with federal, state, and local regulations, and extramural agencies' requirements. 

• Assists with the preparation and presentation of educational programs to groups and individuals in the University research community.  

• Provides regulatory guidance to principal investigators and research teams. 

• Maintains regulatory support related databases and files.  

• Assists with the preparation of quarterly