Manager, Clinical Research

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The Clinical Translational Research Site is currently seeking a full time Manager, Clinical Research to work on-site in Miami.

CORE JOB SUMMARY

The Manager, Clinical Research (A) oversees the development of clinical trials and research programs that support the overall mission of the University. This role is also responsible for the independent execution of regulatory-related decisions/strategies and coordinates work with study managers and other relevant team members to assure the fidelity of study protocols and data collection.

CORE JOB FUNCTIONS        

• Works with investigators and study teams to help meet targets and milestones, ensures timely and accurate submission to IRBs, sponsors and master agreements, and coordinates with the Research Program Director on remediation.

• Coordinates the efforts of relevant team members to manage, retain and control all applicable Regulatory Affairs submissions pertaining to University held INDs and IDEs as well as exemption requests.  

• Assembles project plans, team and work assignments, directing and monitoring work efforts on a daily basis, identifying resource needs, performing quality review, and escalating functional, quality and timeline issues appropriately. 

• Manages investigator relationships. 

• Maintains IND and IDE documentation, including annual reports for delegated studies and works with the primary investigator and project team to assist in responding to queries from regulatory agencies including the FDA. 

• Tracks proposals and other study relevant documentation through signature/approval processes then through collaboration with Contracts and budgets.

• Serves as liaison and facilitates meetings between project stakeholders and leadership and completes and maintains professional documentation for projects and deliverables, develops SOPs as needed, and assists in the auditing and monitoring of studies.

• Identifies areas for improvement within daily functions, internal procedures, and regulatory agency interactions.

• Interacts with project team members to define submission logistics and workflow scheduling. 

• Oversees the ongoing maintenance of records detailing the number of active INDs and IDEs and related data via an internal tracking system. 

• Prepares and presents the annual summary report for clinical trial and research areas. 

• Provides consultation and guidance for UM held INDs and IDEs.  

• Develops, implements, maintains and oversees internal policies and SOPs as well as University‐wide policies and SOPs intended to assist University researchers in maintaining compliance with FDA regulations and other Clinical Research Best Practices. 

• 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.

Department Specific Functions

• Supervise and Lead Clinical Research Coordinators: Oversee the daily activities of the CTRS Clinical Research Coordinators, providing guidance, mentorship, and performance feedback to ensure adherence to study protocols and regulatory requirements.

• Ensure Compliance with Regulatory Requirements: Monitor all clinical research activities to ensure compliance with institutional, federal, and international regulations, including Good Clinical Practice (GCP), Institutional Review Board (IRB) protocols, and FDA guidelines. Responsible for maintaining the CTRS central regulatory binder.

• Manage Study Protocol Implementation: Work together with the CTRS Clinical Research Coordinators to ensure that clinical trials are conducted according to the approved study protocols, including CTRS in-services, site initiation visits, participant recruitment, consent, data collection, and monitoring, to maintain the integrity of the research.

• Develop and Implement Standard Operating Procedures (SOPs): Create and update SOPs, ensuring all CTRS Clinical Research Coordinators follow consistent, efficient, and compliant practices.

• Train and Onboard New