Katherine Buckner
Clinical Research Professional, Family Nurse Practitioner
Brentwood,TN
Summary
Highly experienced and motivated Family Nurse Practitioner with over 15 years of experience across diverse healthcare settings including concentration in multiple progressive roles in clinical research. Leader in clinical trial operations, site oversight, regulatory compliance, and patient safety. Adept in ethical decision-making, informed consent process, protocol evaluation, and Good Clinical Practice (GCP) adherence. Passionate about protecting human subjects and advancing ethical clinical science through collaboration and integrity.
Overview
21
21
years of professional experience
3
3
Certifications
Work History
Regional Director of Clinical Operations
KUR Research - Clinical Research Site Network
12.2024 - Current
- Oversee multi-site operations ensuring compliance with GCP, FDA, ICH, and IRB standards protecting the rights, safety, and well-being of study participants while ensuring credibility and reliability of clinical trial data
- Lead all trial phases including site initiation, recruitment, monitoring, and closeout
- Serve as primary liaison between sites, sponsors, Principal Investigators, CROs, and leadership
- Conduct internal quality audits and oversee protocol adherence and informed consent compliance
- Manage documentation including ICFs, AEs, SAEs, deviations, and source records
- Built and manage a Clinical Data Management team, aligning data integrity with study objectives ensuring clinical data meets GCP and regulatory standards
- Monitor performance metrics and advocate for site resources and needs.
Owner/Operator and Aesthetics Injector
Southern Belle Aesthetics
08.2023 - 02.2025
- Authored comprehensive Standard Operating Procedures (SOPs) and ensured consistent employee adherence through training and oversight
- Ensured office and compliance with all Tennessee Board of Examiners regulations, OSHA standards, and HIPAA requirements
- Perform patient consultations and informed consent reviews for aesthetic treatments
- Administer treatment of neurotoxins, fillers, biostimulants, lasers, microneedling, PRP therapy, and GLP-1 analogs treatment
- Monitor patient responses and educate on safety, risks, and post-procedure care
Family Nurse Practitioner
Optum House Calls, United Health Group
09.2020 - 05.2024
- Conducted comprehensive health assessments including health history, review of systems, medication reconciliation, vital signs, physical exams, and point-of-care testing
- Formulated diagnoses and summary of current and past medical conditions to support care management and medical plans
- Communicate assessment findings to the patient's primary care provider and identify gaps in care or preventative needs
- Provide patient education on disease management, medication adherence, and lifestyle modifications
Clinical Research Nurse Practitioner & Sub-Investigator
Alliance for Multispecialty Research (AMR)
06.2018 - 08.2020
- Coordinated phase 1-4 clinical trials from site feasibility to close-out in accordance with protocol and meeting ICH-GCP, ALCOA-C, FDA regulations, HIPAA, and IRB requirements
- Performed study-related physicals and eligibility screenings per protocol and inclusion/exclusion criteria
- Ensured accurate and timely communication with the Institutional Review Board including protocol amendments and continuing reviews
- Performed the informed consent process and ensured compliance with ethical and regulatory standards
- Administered investigational products, collect and process biological samples, and performed study-specific procedures
- Documented findings in source documents and CRFs; monitored and reported AEs/AESIs/SAEs
- Collaborated with sponsors, monitors, and study staff to support adherence to protocols
Palliative Care Nurse Practitioner
Aspire Health
06.2016 - 06.2018
- Treated patients living with complex, chronic, terminal conditions with the goal of providing comfort and preserving dignity
- Identified physical, emotional, social, and spiritual needs and provided treatment options which aligned with evidence-based guidelines
- Developed and implemented individualized care plans with patients, family members, physicians, nurses, social workers, chaplains
- Facilitated discussions of goals-of-care, advanced directives, and code status determinations
Registered Nurse Care Coordinator
United Health Group
01.2012 - 08.2014
- Developed education plans for patients and families focused on chronic care management
- Coordinated care transitions and facilitated communication between patients and providers
- Facilitated care transitions management, including discharge planning after hospital, ED, or skilled nursing facility stays ensuring timely follow-up appointments and coordination with primary care providers
- Supported the transition of members from long-term care facilities to home and community-based settings coordinating services and resources to promote independence, safety, and continuity of care
Clinical Research Nurse Coordinator
Alliance for Multispecialty Research (AMR)- Formerly VRG
08.2004 - 10.2006
- Coordinated clinical trials from study start-up to close-out in accordance with protocol and while meeting ICH-GCP, ALCOA-C, FDA regulations, HIPAA, and IRB requirements
- Ensured accurate and timely communication with the Institutional Review Board including protocol amendments, and continuing reviews
- Performed the informed consent process ensuring compliance with ethical and regulatory standards
- Administered investigational products, collect and process biological samples, and performed study-specific procedures
- Documented findings in source documents and CRFs; monitored and reported AEs/AESIs/SAEs
- Collaborated with sponsors, monitors, and study staff to support adherence to protocols
Education
Master of Science in Nursing (MSN) - Family Nurse Practitioner
King University
Bristol, TN05-2016
Bachelor of Science in Nursing (BSN) -
King University
Bristol, TN05-2014
Associate of Science in Nursing (ASN) -
Lincoln Memorial University
Harrogate, TN05-2008
Licensed Practical Nurse (LPN) -
Blount Memorial Nursing Program
Alcoa, TN03-2004
Skills
Healthcare management
Patient safety
Clinical leadership
Operational excellence
Certification
- Family Nurse Practitioner - Certified (FNP-C)
Timeline
Regional Director of Clinical Operations
KUR Research - Clinical Research Site Network
12.2024 - Current
Owner/Operator and Aesthetics Injector
Southern Belle Aesthetics
08.2023 - 02.2025
Family Nurse Practitioner
Optum House Calls, United Health Group
09.2020 - 05.2024
Clinical Research Nurse Practitioner & Sub-Investigator
Alliance for Multispecialty Research (AMR)
06.2018 - 08.2020
Palliative Care Nurse Practitioner
Aspire Health
06.2016 - 06.2018
Registered Nurse Care Coordinator
United Health Group
01.2012 - 08.2014
Clinical Research Nurse Coordinator
Alliance for Multispecialty Research (AMR)- Formerly VRG
08.2004 - 10.2006
Master of Science in Nursing (MSN) - Family Nurse Practitioner
King University
Bachelor of Science in Nursing (BSN) -
King University
Associate of Science in Nursing (ASN) -
Lincoln Memorial University
Licensed Practical Nurse (LPN) -
Blount Memorial Nursing Program
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