Jill Anderson CV February ****

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Curriculum Vitae

JILL ANDERSON, BSN, RN

Home Address:

2801A SW Nevada St.

Seattle, Washington 98126 - USA

Mobile: 206-***-****

Email: ad3vyb@r.postjobfree.com

Washington Nursing License:

0058213

Registered Nurse:

State of Washington

Social Security Number:

upon request

Academic and Professional Education:

1972 – 1976:

Washington State University

Intercollegiate Center for Nursing Education

Pullman, Washington; Spokane, Washington

Degree: Bachelor of Science in Nursing

1986:

Business and Economic Statistics

North Seattle Community College

Seattle, Washington

Professional Experience:

October 2023- current:

Vaccine Clinic Registered Nurse

Specialty Medical Staffing, LLC/ Westways Staffing Services Seattle, Washington

2020 (December) to September 2023:

Research Nurse Supervisor

University of Washington/Harborview Center for Pre-Hospital Emergency Care Seattle, Washington

2018 to 2020 (November):

Visiting Nurse - Home Health and Hospice

Kaiser Permanente

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Seattle, Washington

2014 (May) to 2018 (September):

USA Site Management Coordinator – COMPASS Trial

Clinical Trials Service Unit/Cardiology

University of Washington

Seattle, Washington

2005 (Jan) to May 2014:

Director - Clinical and Regulatory Affairs

Seattle Institute for Cardiac Research

Seattle, Washington

2013:

Research Coordinator Consultant

Bardy Diagnostics, Inc.

Vashon Island, WA

Principal Clinical Specialist

Physio-Control, Inc

Redmond, WA

2011:

Clinical Trials Consultant

ThreeWire, Inc.

Eden Prairie, MN

2009:

Medical Device Research Consultant

Ablation Frontiers

Carlsbad, CA

2002 to June 2013:

Medical Device Research Consultant

Field Clinical Engineer Consultant

Cameron Health, Inc./ Boston Scientific

San Clemente, CA

2000 – 2005:

Clinical Trials Coordinator

Seattle Institute for Cardiac Research

Seattle, Washington

1997 – 2000:

Clinical Trials Coordinator

NIH-Sponsored Sudden Cardiac Death and Heart Failure Trial University of Washington Medical Center; Seattle, Washington 1993 – 2000:

Research Nurse II, Div. of Cardiology/Dept. Of Medicine University of Washington Medical Center

Seattle, Washington

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1993 – 1994:

Per Diem Staff Nurse, Critical Care

Harborview Medical Center; Seattle, Washington

1990 – 1993:

Clinical Specialist – Pacing/Implantable Defibrillators Medtronic, Inc.

Kirkland, Washington

1989 –1990:

Project Coordinator, Life Pak-200

Automatic External Defibrillator

Study w/Seattle Fire Department and Medic One Research Harborview Medical Center, Seattle, Washington

1986-1989:

Assistant Head Nurse

Arrhythmia Research Center

Division of Cardiology

University of Washington Medical Center

Seattle, Washington

1986-1991:

Part Time/Per Diem Staff Nurse

Critical Care Float Pool

Harborview Medical Center, Seattle, Washington

1983-1985:

Assistant Head Nurse/Acting Head Nurse

Neurosurgical Intensive Care

Harborview Medical Center, Seattle, Washington

1982-1983:

Staff Nurse/Charge Nurse

Coronary Care Unit

Harborview Medical Center, Seattle, Washington

1980-1982:

Staff Nurse Medical Team

Hospice Community Home Health Care

Seattle, Washington

1977-1980:

Staff Nurse/Charge Nurse

Critical Care

Harborview Medical Center, Seattle, Washington

1976-1977:

Staff Nurse/Charge Nurse, Telemetry Unit

The Doctors Hospital, Seattle, Washington

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Organizations:

American College of Cardiology Member- Cardiac Care Associate European Society of Cardiology Member - Allied Professional Certifications:

Basic Life Support (CPR and AED). American Heart Association. September 2022 CITI Good Clinical Practice and ICH (GCP) April 2021 CITI Collaborative Institutional Training Human Research Curriculum Completion (2018) National Institute of Allergy and Infectious Diseases/ National Institutes of Health Good Clinical Practices Human Subjects and Regulatory Framework Training (2014) Job Duties (October 2023 to current):

Administer a vast array of vaccines in grocery store pharmacies. Screening and monitoring patients for contraindications and side effects to ensure safe practices. Patients include adults and pediatrics.

Job Duties (Dec. 2020 – Sept. 2023):

Program Manager, Clinical Core

Innovative Support for Patients with SARS-COV2 Infections Registry_INSPIRE (CDC- sponsored). Clinical and Regulatory oversight of National Registry of 8 academic enrolling centers in the US. Collaborates, facilitates, coordinates with study sites and study leadership providing study oversight.

Job Duties (Sept. 2018 – Nov. 2020):

Visiting Nurse - Home Health and Hospice- Kaiser Permanante of Washington Provides comprehensive skilled nursing care and services to patients in the home setting. Works on an interdisciplinary team to provide care in the home health, palliative care and hospice programs. Accountable for the assessment, development of plan of care, education and consultation related to pain and symptom management as well as adjustment to changes in health status. Plans for the return of patient care to primary Health Care providers as indicated.

Job Duties (2014- Sept. 2018):

USA Study Management Coordinator (SMC) for Cardiovascular OutcoMes for People Using Anticoagulation StrategieS Trial (COMPASS) - USA National Leader’s Office, Clinical Trials Service Unit, University of Washington School of Medicine. Regulatory and Clinical Management of 28 enrolling centers throughout the USA. Study Research Nurse Coordinator for Cardiovascular OutcoMes for People Using Anticoagulation StrategieS Trial (COMPASS) – Division of Cardiology, University of Washington Medical Center. Local site subject screening, consenting, enrolling/randomization and follow-up.

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Job Duties (2011-2014):

Director of Clinical and Regulatory Affairs – Seattle Institute for Cardiac Research. Maintain research project and institutional procedures and practices that meet research objectives and ensure compliance with all aspects of Institution, Federal Drug Administration (FDA) and National Institutes of Health (NIH) regulations pertaining to clinical research in human subjects. Assist physician scientists with manuscript writing. Consultant to Bardy Diagnostics, Inc. assisting with the clinical and regulatory aspects in new product development.

Consultant to ThreeWire, Inc. assisting with patient identification/screening in accordance with research protocols inclusion/exclusion criteria for Clinical Trial enrollment.

Principal Clinical Specialist at Physio-Control, Inc. Provide clinical expertise in support of the design, development, manufacture and clinical application of Advanced Life Support

(ALS) and Basic Life Support (BLS) products and accessories. Perform clinical activities per Quality System Work Instructions and Technical Standards. Assist with data analysis and reporting for specific investigations related to assigned project or study. Act as a consultant to other functional groups regarding clinical issues. New product development Project Leader of the “Simple ECG Monitoring Trial” for Comparison of a Sternal Patch ECG Recording System with a Standard ECG Recording System for Holter Monitoring, sponsored by Cardiac Science and conducted by Seattle institute for Cardiac Research. This was an International Trial of 50 patients enrolled at 4 centers in the US, Australia and New Zealand. FDA approval was granted to the

“mySense” Ambulatory monitor on Dec. 21, 2011. Duties included Clinical and Regulatory oversight of trial operations.

Job Duties 2002 to 2013:

Consultant to Cameron Health, Inc. in the Research and Development of the entirely subcutaneous implantable defibrillator. Cameron Health was acquired by Boston Scientific in June of 2012 and FDA approval was received on September 28, 2012. Duties include early experience data gathering/report writing to assist in device algorithm development, manuscript preparation, data gathering and field support for 330 patient/32 site IDE trial. Field support includes training and assisting physicians and support staff with device implants, follow-ups and support of a 1600 patient post approval observational study.

Job Duties 1997- 2012:

Project Leader of the National Institutes of Health-Sponsored Sudden Cardiac Death in Heart Failure 10 Year Follow-up Trial (SCD-HeFT 10 Year) comparing 10 year mortality data on the remaining surviving subjects in the original SCD-HeFT study (1855 patients and 110 sites) and conducted by Seattle institute for Cardiac Research. Duties included 24 hour oversight of trial operations i.e.: coordination of study materials, investigator meetings, site start-up, implementation of a web-based database for trial management, FDA and National Institutes of Health budgetary development and quarterly progress reporting, regulatory compliance, site monitoring training, field monitoring, assistance with abstract writing and submission of abstracts to National and International Scientific/World Congress Sessions and physician scientist assistance with manuscript preparation.

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Project Leader of the National Institutes of Health-Sponsored Automated External Home Defibrillator Trial (HAT) and conducted by Seattle institute for Cardiac Research. The HAT Study was an international trial that compared lay use of an Automated External Defibrillator (AED) in the home versus lay activation of standard cardiac emergency medical services (calling 911) for sudden cardiac arrest in patients with a history of an anterior wall myocardial infarction. 7001 patients were enrolled at 180 enrolling centers in the US, Canada, United Kingdom, Germany, the Netherlands, Australia and New Zealand. Duties included Clinical and Regulatory oversight of trial operations as outlined above.

Clinical Trials Coordinator for the NIH-Sponsored Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), an international trial conducted by Seattle institute for Cardiac Research that compared the use of an implantable cardioverter defibrillator (ICD) to that of a potent antiarrhythmic drug, amiodarone to placebo (double blinded) in the primary prevention of sudden cardiac death in Class II and Class III NYHA patients with congestive heart failure. A total of 2521 patients were enrolled from 170 sites in the US, Canada and New Zealand. Duties included Clinical and Regulatory oversight of trial operations as outlined previously.

Skills and Experience:

Federal Grants Management Course for Devices: Comprehensive Training and Certification: Pacemaker and Implantable-Cardioverter-Defibrillator Devices. Phase I, II, III and IV Cardiovascular Clinical Trials Coordination and Project Leadership. Medical Device Research Consultant. Summary Report writing for an Investigational Device Exemption (IDE) application to initiate a Phase III Clinical Trial. Adverse Event Summary Report writing for a Clinical Events Committee/Data, Safety and Monitoring Board to demonstrate safety and efficacy of a novel approach to atrial fibrillation ablation in a Phase III Clinical Trial. Federal Grants Budget composition and management.

Food and Drug Administration/National Institutes of Health Quarterly Reporting. Assist with the composition/presentation of: Research protocols, Operations Manuals, Clinical Research Form (CRFs), Informed Consent Forms (ICFs), Internal Review Board

(IRB) Submissions and Renewals, Newsletters, Abstracts, Posters and Manuscripts for Publication.

Web-Based Clinical Trials management for electronic data forms submission and trial communication.

National and International site monitoring (initiation, recruitment, for cause, close out) and training of Physicians and Allied Health Coordinators. Clinical Events Committee (CEC) Data Management coordination. Site Regulatory Management in accordance with Good Clinical Practices (GCP), International Conference on Harmonisation (ICH) standards, Health Insurance Portability and Accountability Act Compliance (HIPAA), Office for Human Research Protections

(OHRP) and Federal Wide Assurance (FWA) for the Protection of Human Subjects. Jill Anderson CV February 2024

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Domestic/International Investigator Meeting planning and organization. Cardiopulmonary Resuscitation (CPR) and Automatic External Defibrillator (AED) certified.

Computer literacy in Windows XP, Windows 7, MS Word, Excel, PowerPoint, Outlook Express, Adobe Acrobat, Mac OS X, MacBook Pro and MS Office for Mac. PUBLICATIONS:

Upon request.

REFERENCES:

Upon request.

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