Clinical Research Manager

4 days ago

Miami, Florida, United States University of Miami Full time
Job Summary

The University of Miami is seeking a highly skilled Clinical Research Manager to oversee the development of clinical trials and research programs that support the overall mission of the University. This role is 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.

Key Responsibilities
  • 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.
Requirements
  • Master's degree in relevant field.
  • Minimum 5 years of relevant experience.
  • Any appropriate combination of relevant education, experience and/or certification may be considered.
Department Specific Functions
  • The Department of Pathology and Laboratory Medicine (DPLM) is a growing multi-disciplinary department at the University of Miami Miller School of Medicine. It encompasses 4 distinct divisions: Anatomic Pathology, Hematopathology, Comparative Pathology, and Laboratory Medicine. DPLM Research includes all divisions and is divided according to basic, translational, and clinical research. The position of Manager, Clinical Research is expected to:
  • Oversee all pathology clinical research study requests requesting pathology specific services.
  • Manage clinical research coordinators and provide research support to DPLM faculty.
  • Develop DPLM research specific guidelines and SOPs for the proper management of specimen for internal and external purposes.
  • Assist in the development of DPLM research study protocols.
  • Attend and participate in all relevant committees to provide pathology expertise and guidance.
  • Review all research studies submitted to the IRB that requires biospecimen.
  • Assist the Director of Clinical Research in enforcing all DPLM guidelines across all UM department and centers.
Knowledge, Skills and Attitudes
  • Knowledge of business and management principles.
  • Ability to direct, manage, implement, and evaluate department operations.
  • Ability to establish department goals, and objectives that support the strategic plan.
  • Ability to effectively plan, delegate and/or supervise the work of others.
  • Ability to lead, motivate, develop, and train others.

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