Clinical Research Coordinator

Felicity Vaughan, NCMA, CCRC

**** ******** **. • Watauga, TX 76148 • 817-***-**** • ***************@*****.***

CERTIFIED CLINICAL RESEARCH COORDINATOR- II

Talented and results oriented professional with extensive experience in research coordination. Strengths in communicating with subjects, collaboration with teams, and maintaining a detail-oriented and methodical environment. Adept at presenting results in a clear and actionable format for investigators, sponsors, regulatory bodies, and other stakeholders. Ability to adapt and use innovative approaches to meet and/or exceed goals and objectives, while adhering to regulatory guidelines.

CORE STRENGTHS

Research Coordination Management Adaptability Detail-Oriented Dependable

Collaboration Organized & Methodical Calm Confidentiality

Rapport Building Compassion Communication

EXPERIENCE

Re: Cognition Health 10/2023 – present

•Accountable for ICH-GCP compliance across all assigned studies

•To ensure that the highest levels of customer/patient care and clinical delivery are always maintained

•To support the development of the business by working closely with clinicians and consultants to maximize business opportunities and recruit patients

•Adhere to the organization's policies and SOPs and ensure all members of the clinical trials team are trained and compliant

•To ensure that all administration is performed accurately and in a timely way including the entry of patient records on all necessary databases and forms

•To ensure that all patient records are accurate, stored appropriately and all confidential information is retained in accordance with data protection requirements

•To ensure that the Centre is maintained and presented to the highest standards as expected by

•The organization and that all equipment is calibrated and maintained in line with best practice

•To ensure adequate stock within the Centre ensuring that it is ordered in a timely way and that stock is controlled

•To seek feedback from patients as to their experience and record these findings and analyze them to support the ongoing development of the service

•To complete the necessary start-up activities including assisting the Clinical Trials Start Up Specialist with any completion and submission of non-NHS SSI forms to the relevant REC for new studies to be conducted at the Centre as and when required

•To perform internal audits of working practices within the Centre to measure compliance against company SOPs and GCP as and when required

Consultants in Cardiovascular Medicine and Science (Dr Mo Heart) May 1, 2022- 10/2023

Research Manager

Responsible for oversight of 12 TCU medical students

oWriting and submitting new case studies as part of their graduation

oIRB submission

oCoordinate subject visits and follow ups

oData entry and query resolution

Responsible for cardiac clearances

Responsible for prescription refills

Responsible for patient needs/requests/questions

Baylor Scott and White Research Institute (Baylor All Saints Fort Worth) August 2018-May 2022

Certified Clinical Research Coordinator

Adhere to strict FDA guidelines, with attention to detail on all paperwork, deadlines, and data quality for multiple clinical studies.

Responsible for coordinating study-monitoring visits.

Responsible for coordinating research subject informed consent and data entry into appropriate research studies ensuring that all inclusion and exclusion criteria are met.

Responsible for coordinating visits of subjects within the visit window.

Responsible for entering charges into the IWRS system

Responsible for accurately paying the subjects the appropriate stipends per protocol.

Responsible for processing labs

Heartplace Mid Cities (Bedford), TX April 2012 – May 2018 Clinical Research Coordinator

Adhere to strict FDA guidelines, with attention to detail on all paperwork, deadlines, and data quality for a high volume of clinical studies.

Manage every aspect of studies, including contract negotiations, IRB approval/renewal, and data entry into sponsor databases.

Provide excellent customer service during subject scheduling window, consent process, and attendance at subject procedures.

Generated $100k+ in revenue after assuming responsibility for remote and in-clinic device checks and billing old claims.

Collaborated with medical team as long-standing staff member, while serving as backup manager.

Heartplace Arlington, TX November 2010– April 2012

Medical Assistant

Interrogated and programmed pacemakers and defibrillators, and implanted loop recorders.

Evaluated patient wounds after implant and made appropriate changes for optimal device functionality and patient care.

Communicated and explained complex medical concepts to patients and families to facilitate patient comprehension.

Collaborated with medical team as long-standing staff member, while serving as backup manager.

Scheduled variety of procedures and administered EKGs.

Heartplace Plano, TX November 2006- October 2010

Device Technician

Provided patient care and provided technical care for patient devices.

Interrogated and programmed pacemakers and defibrillators, and implanted loop recorders.

Evaluated patient wounds after implant and made appropriate changes for optimal device functionality and patient care.

Communicated and explained complex medical concepts to patients and families to facilitate patient comprehension.

Scheduled a variety of procedures and administered EKGs.

EDUCATION & CERTIFICATIONS

Nationally Certified Medical Assistant 2015– Present

Certified Clinical Research Coordinator 2019 - present

Certified NIH (protecting human research participants) 2013– Present

BLS 2002– Present

NIH SS Certified 2018– Present

The Barthel Index Certified 2018– Present

Modified Rankin Scale Certified 2018– Present

IATA Certified 2018– Present

From

To

Research Summary

Duties in the study

Nov-2014

03/2022

Optisure – Cardiac lead study

Lead Coordinator

April-2015

Nov-2022

Thermacool Smarttouch IDE Cardiac ablation catheter

Lead Coordinator

Dec-2017

Aug-2018

PRECEPT IDE

Contact Force-Sensing Catheter

Lead Coordinator

Apr-2016

Aug-2018

WAVECREST

Left atrial appendage closure device

Lead Coordinator

Apr-2021

May-2022

The OPTION Clinical Trial is a randomized controlled trial comparing the safety and effectiveness of left atrial appendage closure (LAAC) to oral anticoagulation (OAC) therapy for stroke protection in post-ablation patients with atrial fibrillation.

Lead Coordinator

May-2022

Dec-2022

PROACT Xa Participants with an On-X

Prosthetic Heart Valve / On-X aortic valve (a type of mechanical valve) can be maintained safely and effectively on apixaban, an anticoagulant drug different from warfarin.

Lead Coordinator

Aug-2018

May-2022

AIM HIGHer IDE

evaluate the safety and efficacy of cardiac contractility modulation therapy in patients with symptomatic heart failure with an ejection fraction of 40% – 60% (inclusive)

Lead Coordinator

Apr-2015

Nov-2016

S-ICD IDE

The objective of this study was to evaluate the safety and efficacy of the S-ICD in a large diverse population.

Lead Coordinator

Apr-2013

Nov-2016

(QUAD PAS) Quadrupolar pacing post approval study

Lead Coordinator

Apr-2022

Oct-2023

Case Study- Exploring the genome for mechanistic basis of coagulopathy in venous thromboembolic disease patients without a known thrombophilia

Co-Investigator

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