Registered Radiologic CT MRI Technologist Cardiovascular Endovascular Interventional Expert Witness

EDUCATION

Touro University International, Cypress, California
Masters of Science, Health Science, graduated Summa Cum Laude 2007

Athens State University, Athens, Alabama
BS Health Science Management, graduated Cum Laude, 1999

Jefferson State Community College, Birmingham, Alabama
AAS in Radiologic Technology; graduated Magna Cum Laude, 1994

The American Registry of Radiologic Technologist (ARRT) St. Paul, Minnesota
Registry in Radiography R.T. (R), ARRT, July 1994-Current
Registry in Cardiovascular Interventional Technology (CV), ARRT, July 2000-Current
New York State License, Diagnostic Imaging/ Radiologic Technology, 2006- Current
New York State License, Contrast Injection July 2000- Current
California State License, Radiologic Technologist 2012-Current
California State Fluoro Permit 2012-Current
CPR/BLS Certified/ Advanced Cardiac Life Saving Certified ACLS- Current

Thomas Institute of Health Professionals
CT Training Course (16 ASRT CEU) August 2016/ Completed ARRT required CT Clinical Training  CT  Lenox Hill Hospital , New York, NY

PROFESSIONAL EXPERIENCE
Private Company September 2014- Present
Founder/President

• Provide clinical consulting services to early phase medical device companies, specializing in clinical direction.
• Pre-Clinical, First in Man Studies, OUS Approval/ Support, Case Support, Site Management, Regulatory strategies, FDA Study support, CRO Vendor management, Market development, Clinical training.
• Training and proctoring multiple Interventional Radiology/ Cardiology; peripheral procedures.
• Interventional Radiology, Vascular Surgery, Cath Lab procedure support and training/ Clinical Research support for:  Coridea NC2, Cibiem Inc, Claret Medical (Embolic Filter for TAVI), Spectranetics (SFA /BTKDrug Coated Balloon and Laster ), Kona Medical (Ultrasound for RND,)
• Provide Clinical expertise to investors, venture capital funding, and also
• Service an expert witness  for medical malpractice

Cibiem Inc.
Sr. Director of Clinical Affairs June 2012- March 2015

• Manage all aspects of clinical affairs/clinical operations  for an early start-up medical device company
• Responsible for over study management for multiple feasibility EU studies, focusing on Heart Failure and Resistance Hypertension via Carotid Body Removal/ Carotid Body Modulation
• Completed First-in-Man procedures (Surgical and Endovascular case support)
• On site procedure proctoring and training for surgical and endovascular  peripheral and surgical procedures
• Responsible for training the hospital site on procedures, reviewing carotid CT/ CTA exams for subjects, follow-up, tracking any adverse events
• Responsible for all endovascular and surgical case support in Poland, Chez Republic, and United Kingdom.
• Responsible for conducting site selection, qualification visits, budget, contract negotiation with clinical sites, site monitoring plan, enrollment expectations
• Management of Key Opinion Leaders, publications, podium management
• Responsible for  protocol development and CRF (case report form) development, Date Base setup
• Responsible for  vendor management with CRO (clinical research organization) and  core lab(s)
• Setup and training physician, and case support for all  cases
• Managed the submission process to the Competent Authorities, Ethic Committees,  and Ministry of Health in Poland , United Kingdom and Chez Republic for current studies
• Manage CEC (Clinical Events Committee), DSMB (Data Safety Monitoring Board).

Covidien
Global Clinical Research Project Manager March 2011- July 2012
Field based project manager position

• Responsible for over study management for a FDA mandated Post-Market  endovascular peripheral Carotid Stent Embolic Protection Device Study
• Responsible for conducting site selection, qualification visits, budget, contract negotiation with clinical sites.
• Responsible for  protocol development and CRF (case report form) development
• Responsible for  vendor management with CRO (clinical research organization) and  angiographic core lab
• Setup and training physician
• Monitor Case Report Forms to ensure protocol was followed, Good Clinical Practices followed.
• Responsible for reviewing, knowing and updating, Stand Operating Procedure (SOP), and Clinical Regulations, including Good Clinical Practice ensure adherence to FDA approved protocol
• Responsible for training physicians, and cath lab staff on the use of the product and protocol
• Reviewed All Carotid Doppler/ Ultrasound and CT exams with Core Lab
• Supported/ Proctored Carotid Angiography/ Stent cases as needed in the cath lab, operating  room, or Interventional radiology suite
• Supported the acquisition  and transition of Maya Medical  (drug resistant hypertension study via renal nerve ablation)
• Supported  OUS clinical sites for Maya for  multiple study and registry protocols

 

Corindus Vascular Robotics, – Natick MA July 2010-March 2011
“Start-up” Medical Device Company

• Contract Clinical Consultant- Training & Clinical Research Field Manger
• Regional Field based position/ working in corporate headquarters 3 weeks each month, located in Boston, MA
• Responsible for  completing  GLP (Good Laboratory Practice) Animal studies for FDA submission
• Responsible for the development and execution of training plan for investigational device(s){Corpath® 200 System} for robotic assisted angioplasty/stent procedures for 510(k) submission.
• Responsible for conducting site selection, qualification visits, budget, contract negotiation with clinical sites.
• Responsible for  protocol development and CRF (case report form) development
• Responsible for  vendor management with CRO (clinical research organization) and  angiographic core lab
• Developed, managed and directed physician training program for robotics system for interventional cardiologist, consisted of animal lab training  and simulator, bench tope training,  with a goal to safely perform procedure with the Corpath 200
• Proctored First In Man use of the robotic system
• Monitor Case Report Forms (US/OUS) to ensure protocol was followed, Good Clinical Practices followed.
• Responsible for reviewing, knowing and updating, Stand Operating Procedure (SOP), and Clinical Regulations, including Good Clinical Practice ensure adherence to FDA approved protocol
• Responsible for in-service training for cath lab staff on the use of the product, and also responsible for training fellows, and physicians.

 

Rox Medical Inc, – San Clemente, California June 2009- March 2010
“Start-up” Medical Device Company
Clinical Consultant- Clinical Site Manager/ Procedural Trainer
Regional Field based position

• Responsible for the development and execution of training plan for investigational  device(s) AC1, AC2 Device; Interventional Device which creates an  endovascular peripheral Arterial/Venous fistula device via the femoral/Iliac artery/vein for the treatment of COPD
• Investigators include: Interventional Radiologist, Interventional Cardiologist, Vascular Surgeons, and Pulmonary Physicians.
• Responsible for developing and executing  training program for study investigators to include leading animal lab trainings
• Setup and training physician via animal lab to safely perform procedure with the Rox device (teach, scrub, assist, Pan, etc. . ) while training physicians
• Work with Site Managers and CRAs in coordinating site activities and case support
• Monitor Case Report Forms (US/OUS) to ensure protocol was followed, Good Clinical Practices followed.
• Responsible for  managing outside vendor (Core lab) for the pilot study
• Developed and maintained long-term relationships with our investigator group by providing on-going study awareness, education, and clinical expertise regarding the use and application of our AC1 and AC2 product line other study-related products.
• Responsible for reviewing, knowing and updating, Stand Operating Procedure (SOP), and Clinical Regulations, including Good Clinical Practice ensure adherence to FDA approved protocol
• Work closely with the European market to ensure best practices are followed globally; supported multiple sites in Germany and France
• Supported US sites:  Massachusetts  ,  Florida, California, Oklahoma

Bard-Electrophysiology- Lowell, Massachusetts April 2008- June 2009
Clinical Affairs Manager, Research Clinical Specialist
Regional Field based position

• Responsible for day to day management of 5 field based Research Education Specialist (RES)
• Responsible for the development and execution of training plan for investigational HD Mesh Ablation catheter for atrial fibrillation
• Responsible for developing and executing and orientation training program for new hires within Clinical Affairs and the RES team
• Responsible for management of clinical site selection
• Conducted Pre- Study Qualification Visits
• Conducted Site Initiation Visits; training on device, protocol, and GCPs
• Work with Project Management in coordination with CRO of site management
• Developed and maintained long-term relationships with our investigator group by providing on-going study awareness, education, and clinical expertise regarding the use and application of our HDMA Ablation System and other study-related products.
• Responsible for reviewing, knowing and updating, Stand Operating Procedure (SOP), and Clinical Regulations, including Good Clinical Practice ensure adherence to FDA approved protocol
• Responsive for feasibility and post market studies; protocols, and device training.
• Work closely with the European market to ensure best practices are followed : supported European sites in Germany, Italy, Belgium
• Supported site all across the US

Boston Scientific-Natick, Massachusetts 2006- April 2008
Clinical Affairs Manager, Clinical Education Specialist Group
Regional Field based management position

• Manage 8 field based Clinical Education Specialist
• Manage/ facilitate  budget cross franchises
• Manage, Facilitate and execute ILAB/IVUS (Intravascular Ultrasound) with the product launch of ILAB system.  Responsible for Essential I-Learning which included traveling to  clinical sites for 3+ days of training with Cath lab staff and physicians  using  IVUS imaging system, delivering a 5 hour CEU presentation
• Also responsive for training on the rotablator atherectomy system for coronary and peripheral use
• Developed, designed, and executed the content for IVUS Essential program for physicians, fellows, and allied health professionals
• Trained IVUS Speakers/ KOL on IVUS Slide Decks  for major/minor podium presentations
• Supported Neurovascular (Wingspan) and other neuro-interventional devices
• Supported multiple cardiovascular device PMA clinical trials
• Monitored Case Report Forms (CRFs), Performed Site Initiation Visits, Trained sites on Protocol and Good Clinic Practice (GCP)
• Assisted in the development and writing of study protocols
• Post  Market Clinical  Evaluation for Rio™ aspiration catheter
• In-service the cath lab staff and physician(s) participating in the study/product evaluation. Review the case report forms, and necessary study documents required by BSC clinical/regulatory and marketing division.
• Supported sites located across the southeast
• European pre market evaluation of Rubicon™ filter system (Carotid/SVG use) received CE mark/ pending FDA approval
• Physician training on the device reviewed and monitored case report forms. Responsible for device disposition at each assigned site. Supported sites in Germany (Düsseldorf, Munich, Dortmund), Switzerland (Zurich), Spain (Madrid)

Boston Scientific—Maple Grove, Minnesota 2004 – 2006
Customer Market Development Program Manager,  R.T. (R) (CV) ARRT

• Designed, managed and executed 50+ field based Cardiovascular/ Peripheral Vascular/Vascular Surgery (CME) physician training programs/annually; ensured they were aligned with overall company policies, goals and objectives.  Provided support for line marketing in the designing of customer programs that support adoption of interventional procedures and technologies.
• Developed Simulation Training Program for Carotid Artery Stenting with Distal Protection Device (Filterwire)
• Worked in collaboration with franchise marketing management team to design, execute, and evaluate field based customer programs
• Manage on site coordination of assigned field based customer programs
• Routinely generated timely verbal and written communication of the status and marketing impact for assigned programs to external and internal audiences.
• Allocated and manage resources appropriately. Managed budgets, define and implement team processes to ensure executional excellence.
• Monitored customer needs and market development trends to help define new program options and programs
• Built customer rapport and worked with physicians, clinical department managers, hospital administrators.
• Kept abreast of industry standard and trends as related to responsibility and ensure compliance to BSC policy and governing agency guidelines.

Boston Scientific—Mountain View, California 2002-2004
Principal Clinical Research & Education Specialist
Clinical Field Specialist, R.T. (R) (CV) ARRT

Regional– Field Based Position

• Supported  clinical science, sales and marketing in the product launch of the FilterWire EZ, focused on proctoring physicians, CEU presentation, training cath lab Staff and also setting up training for sales force, supported clinical sites in the US and Canada
• Supported the Carotid launch of the Filter Wire EZ launch in Eastern Canada
• Clinically supported a subset of regional target accounts within several of our U. S. driven clinical studies using embolic protection and the Carotid Wallstent. Which included presence in the cath lab to support the use of the FilterWire EX/ EZ Technology in conjunction with the Carotid Wall Stent and other study related devices.
• Developed and maintained long-term relationships with our investigator group by providing on-going study awareness, education, and clinical expertise regarding the use and application of our embolic protection technology and other study-related products.
• Increased staff awareness regarding the BSC clinical study which positively impacted case selection and patient recruitment.
• Responsibilities also included internal communication of any market dynamics relation to competitive devices, and or study activity
• Primary Objectives: Drive patient recruitment/ procedure numbers, relationship development with out key investigator sites; enhance procedure outcomes, market awareness
• Ensured that Federal Regulations, GCP, Company SOPs, and study protocols were in compliance
• Support clinical sites in: Alabama, Florida, Georgia, Kentucky, Louisiana, South Carolina, Tennessee and assist with accounts in the Mid-West and Eastern Canada

Vascular Solutions, Minneapolis, Minnesota 2001-2002
Sr. Field Clinical Specialist, R.T. (R) (CV) ARRT
Field based Position (clinical/sales)

• Consistently met or exceeded assigned quota
• Facilitated sales and growth by conducting physician training and account in- servicing of VSI products (Arterial sealing device, Flowable Hemostat)
• Conducted procedural and product training, provided in-house and on-call
• Technical support for our clinical team, physicians and technologist.
• My Technical astuteness allowed me to keep abreast of effective clinical support techniques and provide input on customers preference; products features and provide ongoing field intelligence on competitive products and marketing activities.
• Assisted with the review and writing of clinical trial protocols, and evaluated future device/ technology
• Assigned territory; southeast, traveled extensively in this position to include, South East,  Mid-West region and European travel/training.

Huntsville Hospital, Huntsville, Alabama 1995-2002
Cardiac Cath Technologist, R.T. (R) (CV) ARRT
X- Ray Technologist

• Operate cineless and cinefluorography diagnostic equipment
• Scrub and assist with the following diagnostic and interventional procedures:  angioplasty, stenting,rotoblator, dvi athrectomy, AngioJet,  Accumetrics (ultegra),  X-ciser, intravascular ultrasound, thrombolytic therapy, peripheral angiography / stenting and  permanent pacemaker implantation
• Assist with the setup and insertion of Swan-Ganz catheters, temporary pacemakers and intra-aortic balloon pumps Angio-seal, Perclose devices, Duett sealing device
• Scrub, perform hemodynamic monitoring and circulate during all cath lab procedures to include peripheral vascular procedures
• Operated digital exam storage (PAC System)

Jackson County Hospital, Scottsboro, Alabama 1994-1999
Radiologic Technologist,
X-Ray Technologist R.T. (R), ARRT

• Perform routine diagnostic radiographic and Cat-Scan (CT) procedures to include: Diagnostic X-ray, Radiology; Radiographic procedures to include fluoroscopy, ER/trauma, surgery,  C-Arm, and portable exams, on pediatric and adult patients
• Worked independently on weekends and night shifts
• Responsible for work flow, and the supervision of radiology assistants
• Responsible for quality control on automatic film processor; as well as the quality of all radiographs performed.
• Assisted in multi-modalities (CT, Ultrasound and Nuclear Medicine)
• Worked PRN from 1995-1999