Experience
The Marie Group brings experience supporting complex clinical research, healthcare, and public health programs in regulated environments, including work performed under direct federal contract.
Our experience includes clinical study monitoring, project management, regulatory coordination, research operations, grant development, and program support. We work across investigators, research staff, healthcare organizations, and other stakeholders to help organizations meet regulatory requirements, manage operational priorities, and advance program objectives.
Featured Experience
Infinite Legacy
The Marie Group provided strategic research and program support to Infinite Legacy, an Organ Procurement Organization (OPO), across internal operations, workforce initiatives, and community-facing programs within a highly regulated and mission-driven environment.
Key contributions included:
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Designed and deployed internal surveys to assess employee perspectives on diversity, equity, and inclusion (DEI) initiatives
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Developed survey tools to assess staff sentiment and organizational readiness during a major organizational merger
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Analyzed survey findings and prepared reports to support leadership decision-making and organizational strategy
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Developed and implemented community education initiatives
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Authored a successful, award-winning grant proposal supporting expansion of a community-based model
National Institutes of Health (NIH)
The Marie Group held a direct NIH prime contract to provide independent clinical study monitoring and research operations support for NIH-funded studies. Services included site monitoring, regulatory documentation review, study readiness assessment, and quality oversight in collaboration with Principal Investigators and research staff.
Key contributions included:
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Led and coordinated site monitoring activities to assess study readiness prior to participant enrollment
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Reviewed regulatory documentation, including investigator training records, study logs, and required study records
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Assessed study infrastructure, including data collection systems and databases, for readiness and implementation
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Verified that study personnel were appropriately documented and authorized through delegation logs
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Assessed implementation of quality assurance and quality control processes
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Identified and communicated issues requiring resolution prior to study launch
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Worked directly with Principal Investigators and research staff to address findings and support study quality and compliance