Hilary K.
Research Compliance Business Partner @Saint Luke's
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WORK HISTORY
Research Compliance Business Partner @Saint Luke's
Kansas City, MO, US
Collaborates with executive leadership, investigators, research staff, Human Research Protection Program, and numerous stakeholders to ensure compliance with applicable institutional policies, sponsor requirements, federal regulations, and international guidelines- Internally audits research-related activities in a variety of specialties- Experience with interviewing personnel and comprehensive review of records to identify and address possible areas of concern, proactively and for-cause- Ensures development and adherence to compliance guidance and (Corrective and Preventive Action (CAPA) plans- Develops, reviews, and revises policies, SOPs, work instructions, and tools- Created and implemented an intuitive tool to assist end users in understanding whether a proposed project is likely Quality Improvement or Research, ensuring projects are then routed for review, support, and oversight- Conducts the annual Research Compliance Risk Assessment and executes the subsequent Research Compliance Work Plan- Chair, Research Compliance Committee- Responsible for coordination and documentation of proceedings- Chair, Research Conflict of Interest Committee- Coordinates, tracks, and assesses disclosures, maintaining thorough documentation- Creates and implements tailored training for faculty and staff- Generates management plans and acts as a liaison between the committee, the Institutional Review Board (IRB), and relevant study team members.
EDUCATION
Drake University
Bachelor of Arts (BA), Psychology
MidAmerica Nazarene University
BSN, Registered Nursing/Registered Nurse
ABOUT HILARY K.
Experienced Clinical Research Professional with a demonstrated history of working within the academic medical center setting. Skilled in research compliance, conflict of interest, clinical trials education, research administration, and study coordination. Strong focus on communication, training, process improvement, and project management.
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