Hybrid Manager, Clinical Research Monitoring na UMiami

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 reports of regulatory activities, summarizing efforts taken and changes to be implemented at both University and department levels. 

• Establishes and continuously assesses the effectiveness of the internal controls within the unit and compliance with University policies and procedures. Ensures employees are trained on controls within the function and on University policy and procedures. 

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 relevant field.   

Certification and Licensing: 

Clinical research certification (e.g. ACRP, SOCRA) 

Experience: 

Minimum 5 years of experience with clinical trials (involving drugs, biologics or devices) required. 

Knowledge, Skills and Attitudes: 

• Strong knowledge of research-related federal regulations (FDA and HHS), guidance documents and state laws  

• Good Clinical Practice (GCP), FDA regulatory requirements and ICH-GCP guidelines 

• Excellent English skills, both verbal and written  

• Excellent interpersonal and team skills 

• Strong attention to detail, time/project management and organization skills 

• Strong Microsoft Office (Excel, Outlook, PowerPoint, Word) skills 

• Ability to meet deadlines, prioritize tasks, and works well both independently and as a team 

• Ability to manage multiple projects and assignments 

• Excellent customer service skills. 

DEPARTMENT ADDENDUM 

Department Specific Functions 

• Manages and coordinates clinical research monitoring resources and workload for studies requiring or requesting regulatory oversight. 

• Assists with defining departmental monitoring processes, strategies, and goals. 

• Oversees management of multiple investigational studies.  

• Provides interpretation and implementation of new regulations or guidance related to monitoring. 

• Escalates any ongoing issues identified from routine monitoring visits to the Director. 

• Collaborates with Data & Safety Monitoring Boards or Committees. 

• Works with Research IT to visualize data related to how studies are monitored, including reports of queries issued in institutional CTMS and EDC systems. 

• Implements and maintains a billing and data tracking structure for monitoring services to recover costs for applicable clinical trials. 

• Reviews and approves the creation and revision of monitoring plans and oversees adherence to them. 

• In collaboration with the Research Quality Assurance team and study teams, assists with external audit preparation activities for studies monitored by IITS-U. 

• Implements and maintains a rate sheet for monitoring services. 

• Creates cost estimates for departments requiring or requesting monitoring services.  

• Develops, maintains, and oversees training matrix for monitors. 

• Makes recommendations on corrective and preventive action (CAPA) plans for studies being monitored IITS-U and refers to RQA for implementation. 

• Conducts or assists with pre-study visits, site initiation visits, routine monitoring visits and close-out visits, as needed.  

• Other duties as assigned.