Experience

Miners Colfax Medical Center

• United States
• Alternative Medicine
• 1 - 100 Employee

• RN

  • May 2015 - Present

  Rural Healthcare Clinic Nurse Rural Healthcare Clinic Nurse



Edwards Lifesciences

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Study Manager

  • Mar 2013 - Present

  Study Manager for Partner II Cohort B Trial Study Manager for Partner II Cohort B Trial


Retired
• Machinery Manufacturing
• 700 & Above Employee
• Principal CRA

  • Aug 2012 - Present
• Sr. Clinical Research Associate

  • Sep 2009 - Sep 2012


PARACOR MEDICAL INCORPORATED

• Senior Clinical Research Associate 2006

  • Nov 2006 - Aug 2009

  Conducted monitoring, audits, training, and proctoring of investigational centers while ensuring compliance with FDA, GCP, and ICH guidelines.Conducted trial activities in a fast paced environment for sites to ensure accurate/rapid data collection with history of minimal deviations for PMA submission. Improved quality of monitoring and data by developing and training clinical site managers and contract monitors in GCP, FDA regulation, and AE/SAE reporting. Ensured a field/site FDA audit with no observations through consulting with data management in the development and presentation of a program to train a consultant group to protocol and case report forms for auditing and monitoring purposes to achieve compliance with protocols, GCP, and federal guidelines. Ensured compliance with FDA and GCP guidelines that resulted with an in-house FDA audit with no observations by developing complete set of SOPs and full range of monitoring forms (from site qualification to site closeout). Streamlined site monitoring by collaborating with director of data management to test and implement Clindex monitoring tools. Clinical Site Manager 2006-2009 Responsible for total account management for the Western Central region to include site relationship building, assisting with regulatory approvals, site budget development, maximizing patient enrollment, assisting with physician referral projects, and procedural support. Increased site enrollments by conducting training on weekends that taught screeners to recognize criteria suitable for enrollment in the trial. Created exhibit tables at seminars that promoted PEERLESS-HF Trial and increased enrollment at sites. Defined and resolved site budget issues concisely and expeditiously, reducing delays in enrollment and surgical device implantation. Facilitated patient enrollment at trial centers by developing a referral process, training site coordinators, and negotiating budgets at referral centers for the PEERLESS-HF Trial.


Medtronic Vascular
• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee
• CRA

  • 1999 - 2007


MEDTRONIC CORPORATION

• Hospitals and Health Care

• Senior Clinical Research Associate

  • Jan 1999 - Jan 2006

  Supported domestic clinical studies for cardiovascular devices including training of clinical investigators and research staff to the investigational product, clinical protocol, data forms and FDA mandated regulations for sixteen clinical trials.Improved the quality of monitoring at Medtronic through timely monitoring processes ensuring compliance with Medtronic SOP's, GCP, and FDA guidelines with no inclusion/exclusion and consent deviations.Timely submission of reports, accurate device accountability, and minimal protocol deviations through development of efficient scheduling and traveling practices and attention to detail and accuracy.Planned and organized work activities to comply with business conduct standards, budget guidelines, and company goals staying within travel/expense guidelines and adhering to policies and business conduct standards.Ensured no 483's from a site FDA audit through maintaining site compliance with protocol, regulations, IRB and Medtronic guidelines and policies at one of the highest enrolling sites.

• Senior Clinical Research Associate

  • 1999 - 2006