Kathryn Epperson
HUNTERSVILLE,NC
Summary
Results-driven professional with expertise in research methodologies and compliance. Manages complex projects, enhances trial coordination, and fosters effective communication for optimal study outcomes. Delivers operational support and streamlines administrative functions to improve efficiency and drive team collaboration.
Overview
13
13
years of professional experience
Work History
Assistant to the Director of Operations
Red Rock Church
Colorado Springs, CO
01.2015 - 08.2017
- Administrative Support: Managed departmental calendars, coordinated mail, and maintained organized digital and physical filing systems to ensure efficient access to information.
- Facility & Logistics: Coordinated event set-ups and tear-downs, scheduled maintenance vendors, and monitored campus cleanliness to support smooth operations.
- Database & Communication: Handled data entry using church management software (like Planning Center) and routed inquiries to appropriate departments for timely responses.
- Database & Communication: Handle basic data entry using church management software (like Planning Center) and route general inquiries.
Senior Site Visit Report Review
Quintiles, Inc
Colorado Springs, CO
03.2012 - 12.2014
- Reviewed complex monitoring visit reports for accuracy, completeness, and alignment with study protocols, annotated reports, and Good Clinical Practice (GCP) guidelines to ensure compliance and data integrity.
- Issue Escalation: Identify, track, and escalate critical site safety trends, severe protocol deviations, and systemic compliance risks to Clinical Trial Managers (CTMs) and project leadership.
- Metric Oversight: Monitor Clinical Research Associate (CRA) performance metrics, ensuring visit report and follow-up letter timelines (MVR/FUL) and action item resolutions are met.
- Cross-Functional Liaison: Act as a central bridge between CRAs, CTMs, and project managers to drive timely resolution of site-level action items.
- Liaised between CRAs, CTMs, and project managers to facilitate timely resolution of site-level action items, enhancing communication and collaboration across teams.
Senior Clinical Research Associate
Quintiles, Inc
Colorado Springs, CO
03.2007 - 03.2012
- Site Management & Monitoring: Execute site selection, initiation, routine monitoring, and close-out visits (both remote and on-site).
- Compliance & Quality Control: Verified source data (SDV), reviewed case report forms (CRFs), and ensured investigational product (IP) accountability to maintain trial integrity.
- Risk Management: Apply Risk-Based Quality Management (RBQM) principles to identify site deviations, perform root cause analysis, and implement Corrective and Preventive Actions (CAPAs).
- Site Relations & Support: Served as primary subject matter expert for clinical sites on protocol interpretation, enhancing patient recruitment and ensuring compliance with safety reporting.
- Documentation & Tracking: Maintain essential trial records in electronic Trial Master Files (eTMF) and Clinical Trial Management Systems (CTMS).
- Guided junior CRAs and site staff in developing essential clinical skills.: Provide guidance, training, and co-monitoring support to junior CRAs and site staff.
Clinical Regulatory Specialist
Quintiles, Inc
Raleigh, NC
03.2006 - 03.2007
- Managed submissions of regulatory packets, protocol amendments, and continuing reviews to IRBs and health agencies, ensuring timely compliance with regulatory requirements.
- Guided research teams by providing training and regulatory advice to investigators and staff, enhancing understanding of compliance throughout the study lifecycle.
- Monitored study start-ups and maintained regulatory databases, overseeing safety reporting to uphold compliance standards.
- Preparing for Audits: Organize documents, track training logs, and support internal or external compliance inspections.
Clinical Research Coordinator
Dr. Richard Weisler & Associates Psychiatry
Raleigh, NC
12.2004 - 03.2006
- Participant Management: Recruited, screened, and enrolled study participants; obtained informed consent and HIPAA authorization to ensure compliance and participant understanding.
- Protocol Compliance: Execute clinical trial protocols safely, adhering strictly to Good Clinical Practice (GCP) and FDA guidelines.
- Data & Documentation: Maintained accurate source documents and entered clinical data into Electronic Data Capture (EDC) systems, resolving data queries to uphold data integrity.
- Clinical Procedures: Collect, process, and ship biological laboratory specimens; monitor participant vitals or perform study tests (e.g., ECGs).
- Safety & Reporting: Monitored subjects for adverse events and reported findings to Principal Investigators (PIs), Institutional Review Boards (IRBs), and sponsors to ensure participant safety.
Education
Master of Science - Clinical Research
Drexel University
Philadelphia, PA06.2009
Bachelor of Science - Biological Psychology
University of Maryland, Baltimore County
Baltimore, MD12.2004
High School Diploma -
Northern High School
Owings, MD05.2000
Skills
- Clinical research methodology
- Clinical research regulations
- Clinical documentation
- Protocol writing
- Compliance assessment
- Trial coordination
- Clinical research engagement
- Clinical training
- Patient engagement
- Meeting facilitation
- Verbal communication
- Content editing
Timeline
Assistant to the Director of Operations
Red Rock Church
01.2015 - 08.2017
Senior Site Visit Report Review
Quintiles, Inc
03.2012 - 12.2014
Senior Clinical Research Associate
Quintiles, Inc
03.2007 - 03.2012
Clinical Regulatory Specialist
Quintiles, Inc
03.2006 - 03.2007
Clinical Research Coordinator
Dr. Richard Weisler & Associates Psychiatry
12.2004 - 03.2006
Master of Science - Clinical Research
Drexel University
Bachelor of Science - Biological Psychology
University of Maryland, Baltimore County
High School Diploma -
Northern High School