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Work experience

Jun 2009Present

Product Analyst II

Boston Scientific Corporation

Achievements:

  • Learning how to complete an MDR.
  • Combined my clinical knowledge with my technical understanding of devices to determine FDA reportability.
  • Used my clinical background in cardiology to improve my coworker's technical understanding.

Responsibilities:

  • Evaluate each event for FDA reportability.
  • Coordinate the event information, device investigation, MDR creation, and medical investigation prior to closing an event/complaint in the complaint handling database.
  • Contacting the sites, sales representatives or physician's to obtain more information and clarification of events.
  • Assure the quality of all complaint information prior to closing an event/ complaint.
Sep 2007Jan 2009

Clinical Research Associate

Achievements:

  • Assisting with preparation and organization of Pre-Market Approval submission.
  • Preparation of source documents for Clinical Events Committee meetings.
  • 800 patient enrollment study with 85 sites to start.

Responsibilities:

  • Protocol support for Clinical Trial Sites and Field Staff.
  • Assisting with development & maintenance of clinical monitoring electronic reports.
  • Assisting company with shift from clinical trial to commercial.
  • Data entry of Clinical Reporting Forms from clinical sites in a double entry database system.
  • Weekly review of electronic monitoring reports.
Aug 2004Sep 2007

Customer Support Specialist

Acist Medical Systems, Inc

Achievements:

  • Built strong working relationships with Customers and Field Staff.
  • Implemented processes in database to streamline processes that use to be done by hand.
  • Worked very closely with Quality Assurance & Regulatory Department when a complaint needed to be escalated to their level.

Responsibilities:

  • Answering calls pertaining to troubleshooting and repair processes on the Acist Injection system to customers & field staff.
  • Transacting any concerns or repairs through proper databases.
  • Utilizing my clinical background in cardiology to help educate customers and staff on functions our system performs in the Catheterization Laboratory.
  • Generate queries within the databases to track the process of transactions in programs.
Jan 1998Aug 2004

Administrative Support, Health Unit Coordinator, Cardiovascular Technician

Unity Hospital, Allina Health System

Achievements:

  • Utilized my clinical skills to verify data quality in report generation.
  • Mastering several databases used during my employment at Unity Hospital.
  • Designed & organized effective skill inventories to train staff.
  • Created & executed effective training curriculums for staff.
  • Helped with upgrades of current database & implementation of new cardiac database that was used Allina wide.

Responsibilities:

  • Generate reports from databases.
  • Data entry into various databases used in Cath Lab or hospital.
  • Development of worksheets to ensure collection of all pertinent data.
  • Knowledge of computerized hemodynamic monitoring systems, with the ability to do hemodynamic calculations by hand, if needed.
  • Able to quickly & accurately apply data to clinical needs.
  • Assessed & prioritized incoming patients to receive proper treatment.
  • Ordering patient's procedures & tests via computerized ordering system.
Jul 1990Jan 1998

Cardiovascular Technician

Achievements:

  • Displayed rapid learning & comprehension of new pieces of equipment.
  • Excellent equipment troubleshooting skills in clinical & non-clinical settings.
  • Conducted yearly certification of coworkers on a radiometer type blood gas machine.

Responsibilities:

  • Collected & compiled research data in cardiac catheterization laboratory setting.
  • Knowledge of computerized hemodynamic monitoring systems with the ability to do hemodynamic calculations by hand, if needed.
  • Knowledge of hemodynamic collection & calculation in the congenital heart defect population.
  • Able to quickly & accurately apply data to clinical needs.
  • Conducted daily quality control & basic maintenance on various pieces of equipment.

Education

Completed Pre-requisites for RN program. Accepted into the RN program, put enrollment on hold.

19831986

Bachelors

Participated in an Internship in Cardiac Rehabilitation.

19821983

University of Delaware

1 Year of General Credits then transferred to West Chester University.

Skills

Microsoft Office Skills
Instruction & Development of Learning Strategies
  I love teaching what I know and what I have learned. I know how hard it can be to figure out how to do a job, be a patient, use a piece of equipment. I have designed and organized effective skill inventories and training curriculums used to educate and train staff and customers. I have helped train co-workers and customers on the use of databases and equipment. I also pride myself on being able to take something technical and target it towards the level of my audience.
Interpersonal Skills
I take the responsibility of using interpersal skills very seriously. I have had to use these skills as part of my bedside manner when working with patients or customers in all of my job experiences. In order to be able to work as a team player in all of my work settings, I have had to use my interpersonal skills with coworkers. I have attended many inservices, courses and college classes that have pertained to this subject matter.
Equipment Maintenance and Troubleshooting
During my years working in the hospital I was involved in using several pieces of diagnostic and technical equipment. I have had experience with EKG, Stress Test, Blood Gas Analyzers, VO2 Uptake Collection Devices, hemodynamic monitoring equipment, IVUS equipment, and other forms of capital equipment used during procedures. I also became a champion user and instructed other staff members in their use and upkeep. I was also very proficient with the maintenance and troubleshooting of these devices. I attended the manufacturer's training on the maintenance of a Radiometer ABL500 Blood Gas Analyzer. All of this experience was helpful in my gaining employment as a Technical Customer Support Special with Acist Medical Systems.

References

Lesli Hanlin

I have worked with Lesli at Abbott Northwestern Hospital and Unity & Mercy Hospital. We have taken college courses together. We have provided training to each other while working in the cath lab.

Lesley Bode

I worked with Leslie at Acist Medical Systems, Inc. I would collaborate with Leslie on making sure the correct customer information was entered in our databases and in ERP system for any Sales Orders that were completed in our department.

Carl Beaurline

I worked with Carl at Acist Medical Systems, Inc. Since I was the first line for any complaint handling, I would often have to work with Carl when a reported issue needed to be escalated to a higher priority. He has also been a mentor to me in the launching of my medical device industry career.

Terri Rolland

I worked collaboratively with Terri on various projects during my time with Acist. Most projects completed in the Clinical Department were a team effort.

Additional Profile Information

Portfolio

Objective

I wish to obtain employment that utilizes my experience in cardiology, database usage, teaching, and customer contact.

Summary

I have had about 18 years experience in Non-invasive and Invasive Cardiology. I have also been involved with clinical data entry and Clinical Research. My strength areas include:
  • Active Learning
  • Complex Problem Solving
  • Critical Thinking
  • Equipment Maintenance
  • Instructing and Precepting
  • Developing Learning Strategies
  • Service Oriented
  • Social Perceptiveness
  • Troubleshooting Skills
  • Microsoft Office Skills
  • Database Skills
  • Interpersonal skills

Salary Requirements

$55,000.00 - $65,000.00 Yearly