Clinical Research Centers Operations

Throughout the network, some research groups maintain their own regulatory and coordinating research teams, while other investigators utilize more centralized support. The Clinical Research Centers Operations Office promotes easy access and use of clinical research operations support for investigators in the conduct and management of human subjects clinical research. It provides a primary point of contact for sponsors and investigators interested in conducting clinical research at HMHRI and assists investigators with study feasibility analysis, staffing per study needs, recruitment, patient navigation, data collection and essential document management.

Research coordination services include:

• Provide CITI certified, Good Clinical Practice-trained staff
• Conduct study feasibility/population assessment/project planning
• Develop study recruitment/retention strategies
• Manage study start up, ongoing conduct and close out
• Conduct the informed consent process
• Draft and submit the IRB application
• Manage regulatory documentation
• Track recruitment
• Collect/process specimens
• Manage study data and query responses
• Manage the trial-related finances
• Administer treatment/medication
• Review contracts for alignment with informed consent
• Review study quality assurance

For more information about the Clinical Research Center Operations Office services, please contact clinicaltrials@hmhn.org.