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Clinical Research Manager

2 months ago

Coral Gables, Florida, United States InsideHigherEd Full time
Job Summary

The Clinical Research Manager will 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
  • Collaborate with investigators and study teams to meet targets and milestones, ensuring timely and accurate submission to Institutional Review Boards (IRBs), sponsors, and master agreements.
  • Coordinate the efforts of relevant team members to manage, retain, and control all applicable Regulatory Affairs submissions pertaining to University-held Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications, as well as exemption requests.
  • Develop and implement project plans, team assignments, and work efforts on a daily basis, identifying resource needs, performing quality review, and escalating functional, quality, and timeline issues appropriately.
  • Manage investigator relationships, maintain IND and IDE documentation, including annual reports for delegated studies, and work with the primary investigator and project team to assist in responding to queries from regulatory agencies, including the FDA.
  • Develop, implement, maintain, and oversee internal policies and Standard Operating Procedures (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.
  • Establish and continuously assess the effectiveness of internal controls within the unit and compliance with University policies and procedures, ensuring employees are trained on controls within the function and on University policy and procedures.
Department-Specific Functions
  • Oversee all CFAR Population Engagement Core research study requests for services.
  • Manage clinical research coordinators and research assistants and provide support to faculty, developing Population Engagement Core SOPs for the creation of a service center.
  • Assist in the development of research study protocols, maintain regulatory compliance for all CFAR Population Engagement studies, and coordinate with other CFAR cores to ensure seamless integration of research services.
  • Monitor and report on the progress of Population Engagement Core projects, facilitate training and development programs for staff to enhance research capabilities, and collaborate with external partners and stakeholders to promote CFAR research initiatives.
Qualifications
  • Master's degree in a relevant field.
  • Minimum 5 years of relevant experience.
  • Knowledge of business and management principles, ability to direct, manage, implement, and evaluate department operations, establish department goals, and objectives that support the strategic plan, effectively plan, delegate, and/or supervise the work of others, lead, motivate, develop, and train others.