LISA R. EDGERTON

Fuquay Varina, NC ***** 919-***-**** ad2w3x@r.postjobfree.com

CLINICAL RESEARCH SITE MANAGER

Trial Management and Execution — Research Operations Oversight — Patient Recruitment and Retention

Empowering Clinical Research through Patient-Centric Strategies and Operational Efficiency to Maximize Study Outcomes.

Distinguished leader bringing to the table over 2 decades of experience in clinical research and unparalleled success in managing multi-specialty research operations. Renowned for developing and executing research strategies, optimizing trial performance, and ensuring data quality through targeted action plans. Trademark excellence in leading research operations colleagues, managing budgets, and collaborating with leadership, physicians, and practice administrators to bolster patient recruitment, promote staff development, and support investigator-initiated trials for publication.

§ Clinical Research Operations § Trial Performance Improvement § Data Quality/Sunshine Act

§ Lab Assessments, CLIA § ISO 14155/CFR Title 21 Compliance § Study Procedures Execution

§ Budget Development/Management § IRB Submissions/Regulatory § Staff Training and Mentoring

§ Patient Scheduling/Correspondence § GCP/ICH/GXP/GMP Auditing §Cross-functional Team

§ Patient Care Aide/MA § American Red Cross-BLS Leadership

CLINICAL RESEARCH EXPERIENCE AND MILESTONES

HOYA Vision, Beverly, MA December 2023–Present

Clinical Site Manager/Senior Clinical Research Associate Consultant (Contract-part-time)

Served as Lead Clinical Trial Manager Consultant for a medical device company focused on class 2 ophthalmology products le is related to a pediatric ophthalmology study focused on a spectacle lens for children ages 7-10 which is a a 3-year pivotal class 2 de novo study. They are looking for a Clinical Trial Coordinator to come on for about 5 hours a week to provide input and insight and lead the team in the proper direction in preparation for this study to get kicked off mid 2024.

Site Manager that serves as the primary contact point between the Sponsor and the Investigational Site.

Site selection/qualification/pre-trial assessment/feasibility/subject recruitment and planning.

Medical writing and review of all study documents.

Assigned to 9 trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure.

Onsite and remote monitoring from inception to close out.

Assisting with Local/Clinical Trial Manager and Clinical Trial Assistance of related protocol activities for process improvement and training.

Attendance of Weekly meetings to guide team for FDA approval.

Medtronic, Minneapolis, MN November 2022–July 2023

Senior Clinical Research Associate – Medical Devices (Contract)

Served as lead clinical research associate, managing 9+ sites across the US for critical diabetes device study, facilitating optimal site performance and patient safety. Conducted comprehensive site management through extensive travel, coordinating end-to-end operations and upholding the highest patient safety and study integrity standards.

Established partnerships with clinical sites, fostering tailored support for patient recruitment, averaging 30-50 patients monthly.

Enforced FDA regulations across all studies, promptly identifying safety concerns and reporting findings to Medtronic and institutional review board (IRB).

Audited complex study data for accuracy, uncovered discrepancies, and delivered group training to 20-25 staff members, including site coordinators, medical assistants, RNs, and physicians, elevating clinical study skills and performance.

Facilitated timely submission of follow-up monitoring reports, including site qualification, initiation, interim, and close-out visits to FDA and sponsor, capturing all corrective actions for short-term studies averaging 17 days each.

IQVIA, Durham, NC January 2022–July 2022

Senior Clinical Research Associate – Medical Devices (Contract)

Managed diverse clinical research projects as central trials conductor, investigator, and patient recruitment specialist, overseeing full project lifecycle from initiation to completion. Coordinated site management and monitoring activities for phase II, III, and IV clinical trials, epitomizing expertise in medical devices, cardiology, and wound care.

Partnered with stakeholders, investigators, and clinical operations administrators to keep clinical trials within scope and budget.

Oversaw budgets of ~$600K per study, enrolling ~2,000 participants in each trial nationwide; conducted inclusion/exclusions and data analysis for optimal site identification and patient recruitment.

Led UK-based Smith and Nephew wound and burn care study, directing study start-up, site monitoring, feasibility studies, and ensuring compliance with EMA, FDA, and ICH regulations.

Associated Urologist, Raleigh, NC October 2021–January 2022

Clinical Research Coordinator Data Manager (Contract)

Transformed underperforming clinical research operations in urology and cancer studies by providing troubleshooting and advisory support. Increased participation from zero to 15+ patients per study as a trusted advisor and key resource in clinical research operations.

Spearheaded implementation of onsite laboratory services, saving each site $200 per patient per visit, and secured buy-in for an onsite radiology clinic, reducing costs by $2500+ per MRI per patient.

Identified operational improvements for prostate and bladder cancer studies, leading site to recover $300K in lost revenue.

Patient procedures: Labs-phlebotomy, urinalysis and scans for oncology patients.

Developed data entry standards to reconcile 500+ queries, yielding monthly recoupment of $20-30K per study.

Parexel International, Durham, NC August 2021–November 2021

In-House Clinical Research Associate (Contract)

Contributed to site start-up, enrollment, and service execution for studies in pediatric cardiology, rare diseases

(Ehlers-Danlos syndrome), nephrology, and oncology. Identified 100+ sites, conducted pre-site visits, conducted feasibility assessments, and narrowed prospects to 37 participating locations.

Led functional clinical research activities, orchestrating study participant planning and research developments; assessed large data sets, conducted clinical research data analysis, and presented

complex reports.

Directed regulatory coordination, budgeting, financial analysis, and pediatric research operations; guaranteed high-quality delivery of research in phase II, III, and IV clinical trials through daily processes and procedures.

Trained new clinical research staff and advocated for team continuous learning, implementing strategic training program to enhance recruitment, patient onboarding, data entry and analysis, compliance, and ongoing education.

Calyxo, Inc. (Contract Partner to Consign Med), Pleasanton, CA November 2020–June 2021

Senior Clinical Research Associate, Kidney Stone Medical Device (Contract)

Partnered with clinical stakeholders in a medical device project, performing site initiation visits, monitoring, and study execution at 6 sites across southeast region. Delivered surgical technique training and proctoring cases at hospitals and surgical care facilities. Maintained compliance with CFR Title 21 CFR Part 803, 812, 814, 50, and 56 and international standards.

Blue Cross Blue Shield. (Contract Partner to Green Key Research), Durham, NC February 2020–April 2020

HEDIS/Quality Improvement Data Analyst (Contract)

Provide analytical expertise and operational support to the HEDIS/Star Programs and data QA and reporting. Responsible for identifying and quantifying key drivers, investigating areas of opportunity, evaluating effectiveness and making recommendations. Apply business knowledge to analytics projects and provide value-added insights to impact business outcomes. Managing of healthcare analytics-based data sets in a hospital/medical office of insurance plan environment. Collected medical records for hypertension and diabetes patients to meet metrics for HEDIS.

Alliance Urology Durham Nephrology, Greensboro and Durham, NC October 2018–February 2020

Clinical Research Associate >> Clinical Research Manager

Managed clinical research operations at 8 dialysis centers and a nephrology clinic, supervising team of 3 research coordinators, and overseeing studies in urology and nephrology. Increased study budgets from $27K to $58K per patients and doubled number of trials in six months, while commanding investigator staff of sixteen in nephrology, including hiring, training, annual reviews, and discipline.

Sanford Cardiology, Sanford, NC April 2018–September 2018

Lead Research Coordinator, Interventional Cardiology (Contract)

Helmed cardiology studies on stents, MI, cholesterol, and angina, directing patient recruitment, site monitoring, laboratory procedures, and regulatory processes. Performed life-saving CPR on a patient during a study. Maintained 99% patient retention rate.

National Intrepid Center of Excellence, Fort Campbell, KY March 2016–March 2018

Clinical Research Study Manager (Contract)

Directed design and execution of a $20M research study on traumatic brain injury with vision and hearing issues

in soldiers, subsequently promoted to associate investigator, coordinating neuropsychological and behavioral

health assessments. Led team of 70 staff, providing quality management and regulatory/IRB submission support across ten hospital departments. Developed WIIR database to track psychological studies and treatment outcomes for service members.

Earlier Career:

Lead Data Manager, Diabetes and Cystic Fibrosis (Contract) Quintiles (August 2015–February 2016)

Drug Safety Specialist I and II (Contract) Pharmaceutical Product Development (February 2015–August 2015)

Research Project Manager and Analyst (Contract) General Dynamics Information Technology (June 2014–February 2015)

Clinical Research Coordinator II >> Clinical Research Manager (Full-Time) Novant Health (March 2007–June 2014)

Hospital Corpsman, Petty Officer 3rd Class >> US Naval Reserves (Full-Time) (February 1991-July 2004)

EDUCATION AND PROFESSIONAL DEVELOPMENT

Bachelor of Science (BS) in Biology (Minor in Chemistry), Ohio Dominican College, Columbus, OH

Associates Degree- Medical Assisting, Fort Hayes Career Center, Columbus, Ohio

Clinical Research Associate (CRA), Association for Clinical Research Professionals (ACRP)

Certified Clinical Research Coordinator (CCRC), University of Southern Florida

Good Clinical Practice (GCP) Certification, Medtronic IRB Regulatory Certificate, Duke Hospital

First Aide/CPR/BLS Certificate The American Red Cross-Synergy

TECHNICAL ACUMEN

AHLTA Allscripts BioClinica SharePoint LMS CTMS Clinical Conductor ClinPhone/IVRS, Microsoft Office e-ClinicalWorks Electronic Trial Master File(e-TMF) EPIC HAIMS e-IRB RDC/ EDC LIMS Medidata Rave Clinical Cloud Oracle-Argus RedCAP SIMS VEEVA Vault Long-Boat Cerner LIS Electronic Notebook

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