Jennifer M. Kuyl, RN, BSN, CCRP, CHRC

**** ******* **** ** *-mail adwec1@r.postjobfree.com

Placerville, CA 95667 Cell 1-707-***-****

Experienced Research Nurse / Research Quality and Compliance Professional

Nursing professional with 30 years experience, specializing in oncology and hematology, regulatory compliance and quality assurance

PROFESSIONAL PROFILE

RN State of California – 710702

Proactive self-starter with track record of initiative, personal responsibility, ownership of work and reputation for creativity, visionary thinking and making things happen

Proven leader who effectively motivates others and directs top-level strategic initiatives

Expert training and education content developer in GCP and quality assurance

Initiates goals and methodical plans to capture quality assurance data, provides root cause analysis and promotes solutions to improve outcomes

Highly analytical thinker with demonstrated ability to combine clinical judgment whilst scrutinizing complex research data

Empathetic interpersonal communicator, presenter, and negotiator; delivering time-critical solutions for senior executives inline with corporate goals

Creative, dependable, and enthusiastic change agent with proven track record in project delivery

Able to maintain professional focus under stress whether patient-care scenarios or in achieving corporate deadlines

Highly regarded and respected by both academic researchers and clinical practitioners

Kaiser Permanente Institutional Review Board Member 2015 to Present

AREAS OF CLINCAL and RESEARCH EXPERTISE

Hematologic Malignancies/Bone Marrow Transplant

Medical Oncology (Breast, Lung, Colon)

Chemo-, Radio- and Bio-therapy

Neurology/Acute Stroke Treatment

ALS/Neuro-Ophthalmology

Cardiology (Critical care, Out-patient care)

Internal Medicine

Medical Devices (Neurology and Cardiology)

Clinical Trial Monitoring and Auditing

Protocol and CRF Design

Listing Reviews

Participation in FDA and Cooperative Group Audits

Clinical Trial Design, Initiation and Monitoring

Pharmacovigilance

Clinical Expert for Legal Review

Experience with Phase I to IV Clinical Trials

EDUCATION and TRAINING

2021, Aspen University, Aspen, Colorado, Bachelors Degree in Nursing

2010, Oncology Nursing Society Oncology Certified Nurse

2007, Portland State University, General Course Work

2006, Oregon Health & Sciences University, Nursing Course Work

2000, Society of Clinical Research Associates Certified Clinical Research Professional

1995, Professional Research Opportunities, Certificate of Completion as Clinical Research Coordinator

1993, St. Lukes Medical Center, Phoenix, Arizona, Certificate of Completion in Critical Care Nursing

1993, Portland Community College, Portland, Oregon, Associate Degree of Nursing

CERTIFICATIONS

2023 Certified Healthcare Research Compliance through HCCA

2010 to 2018, Oncology Certified Nurse

2000 to Present, Certified Clinical Research Professional SoCRA

2008 Human Participant Protection Education for Research, NIH

2009-2014, Chemotherapy and Biotherapy Certified

1998-2008, NIH Stroke Scale Certified

2012-2014 Healthcare Provider Basic Life Support

EMPLOYMENT HISTORY

2015- present, Kaiser Permanente, Oakland, California, Program-Wide

Director of Clinical Trials Regulatory Compliance

Directs and implements the operational aspects of the KPNC clinical trials internal quality assurance audit program and provides oversight of the clinical research regulatory compliance support program in a complex regional research infrastructure

Oversee and audit of Adult and Pediatric Oncology (all solid tumor and hem malignancy) sponsored and cooperative group protocols.

Oversee and audit additional therapeutic areas including Cardovasucular, Neurology, Infectious Disease, Vaccine, and GI protocols

Creation of training and education on GCP and quality concepts for research and IRB staff

Creation of research specific policies and standard operating procedures

Provides supervision to licensed and non-licensed research compliance staff and leads the team in a manner that effectively supports investigators and staff to be compliant with clinical research standards, federal, state, and local regulations and KP policies in multiple facilities across the region

Guides and communicates Federal Regulatory, ICH GCP, State and local research regulation.

Communicates through high level presentations root cause analysis, and CAPA proposals

Collaborates with other regional research and compliance partners to protect, preserve, and promote mitigation of risk to KP research participants, staff, investigators and KP

Member of KPNC IRB

2014-2015, Jazz Pharmaceuticals, Palo Alto, California

Clinical Science & Operations Specialist

Project Managing Historical Control Group Data for Phase 3 registration trial in Veno-Occlusive Disorder. FDA approval for Defibrotide was March 30, 2016

Lead a team of 7 contract and staff Nurse Practitioners, Medical Science Liaisons, and coordinators

Managing, Tracking and Coordinating Review Process of Multiple Complex Listings

Onsite Data Reconciliation in US and International Medical Centers

Developed formalized procedure for quality review for historical control group

Developed standard operating procedure for data change management

Training of multiple team members on bone marrow transplantation

2009-2014, St. Helena Hospital, St. Helena, California, Martin O’Neil Cancer Center

Research Nurse Coordinator/ Lead Clinic Nurse

Patient care duties including chemotherapy administration, radiation nursing, clinic nurse duties, and patient recruitment into trials

Created and administered local tumor board and coordinated with UCSF tumor board for presentations

Coordination of 20 oncology research protocols with responsibility for Budget and Contract Review

Coordination of trials with University of California, San Francisco

Regulatory and data submissions with 1 data manager for support

Developed standard operating procedure for investigational pharmacy

Developed training and educaiton on GCP, quality, research concepts for entire department

Clinical follow-up of patients receiving therapy on clinical trials

2013 Contract Work, 2008-2009, Kaiser Permanente, Oakland, California, Kaiser Foundation Research Institute

Clinical Trials Quality & Compliance Coordinator

Compliance monitoring and auditing of all clinical trials across all specialties at hospitals and clinics in the Northern California Region. Specialties included oncology, gastroenterology, pediatrics, cardiac, internal medicine

Developed standard operating procedures for internal audit function, regulatory and GCP compliance, and non-compliance escalation

Internal quality data reporting of clinical trials to the Kaiser Foundation

Training of GCP practices and report quality improvement standards to physician practice groups conducting research

Managed 1 nurse and 2 data coordinators on the compliance monitoring and auditing team

2006-2008, Oregon Health & Science University, Portland, Oregon, OHSU Cancer Institute

Director of Clinical Research Management

Oversight of all oncology protocols at OHSU

Development of training and education in GCP and quality for Oncology program staff

Member of the Data Safety and Monitoring Board

Auditing of Investigator Initiated and National Cooperative Group Cancer Trials

Annual NCI (National Cancer Institute) Report

Managed Cancer Review Committee (Scientific Review Board)

Managed shared resource of 11 CRAs, 3 Managers and ca. 20 Indirect Reports (University Oncology Departments)

Reviewed and approved clinical trial budgets and grant funding of ca. 3 M$

Member of the IRB Leadership Council

2000-2006, Oregon Health & Science University (OHSU), Portland, Oregon, Department of Hematology Oncology

Instructor in the Hematologic Malignancies /Bone Marrow Transplant Program / Research Nurse Manager

Collaborated on design and execution of Investigator Initiated Protocol for Brian J Druker, MD /

Michael O’Dwyer, MD / Michael J Mauro, MD utilizing Gleevec®

Reviewed and approved clinical trial budgets

Responsible for shared resource of 12 direct report CRAs

Assisted with preparation for FDA audit for fast track Gleevec® (Glivec) approval.

Site Initiation and training, quarterly monitoring, site close out at the following institutions:

UCLA Leukemia Program Hem/Onc Department, Los Angeles, 2001-2004

City of Hope, Hematology, Duarte, 2002-2004

Northwestern University, Chicago, 200*-*******

Dana Farber Cancer Institute, Boston, 2002-2005

1999-2000 Oregon Health & Science University (OHSU), Portland, Oregon, Department of Neurology

Instructor in Neurology ALS center/ Research Nurse Coordinator, Department of Neurology, OHSU

Developed study budgets, contract negotiation with sponsors, maintained regulatory files, coordination of study visits, and completion of CRFs

Entered data into national ALS registry of cases seen at OHSU

Supported ALS clinic, pulmonary function testing, mini-mental status exams, neuro assessments, home visits to support families and patients in crisis, completed rounds on in-patient unit with neurology team

Organized an educational ALS seminar and fund raising event for health care practitioners and community members. Raised $35k for ALS research.

1997 -2007 Oregon Health & Science University (OHSU), Portland, Oregon, Department of Neurology Instructor in Neurology Oregon Stroke Center / Acute Stroke Research Nurse Coordinator, Department of Neurology, OHSU

Acute stroke call for all of the Portland Metropolitan Hospitals that included bedside stroke management with administration of t-PA, investigational neuro-protectant drugs in the ER and ICU, investigational devices and drugs in the interventional cath lab

Monitored and collaborated with satellite study centers over the entire state of Oregon on stroke management and investigational protocols

Participated in community outreach by giving talks about warning signs of stroke

1996-1997, Nurse Supervisor / Clinic Nurse, Sunset Family Practice, Portland, Oregon

Nurse Supervisor for a busy 5 physician family practice. Supervised 3 RNs and 3 medical assistants

Created workflows and managed clinic triage line

Assisted physicians in minor procedures laceration repair, biopsy, and casting

Interim practice manager which included management of practice funds, HR duties, and billing

1995-1996, Clinical Research Coordinator, Clinic Nurse, Hillsboro Cardiology, Hillsboro, Oregon

Cardiac clinic nursing included triage, coagulation management, pacemaker checks, EKGs, exercise stress tests, and general patient teaching and management

Initiated and managed 5 clinical trials including regulatory duties and clinic follow-up visits

Supervised 1 data manager

1993-1995, Advice/Triage Nurse Family Practice, Team Leader Family Practice HealthFirst, Portland, Oregon

Clinic advice and triage nurse for busy 15 practitioner office and handled an average of 120 calls per day

Supervised 3 medical assistants in adult family practice section

Assisted in minor procedures such as vasectomies, laceration repair, and casting

Assessed walk-in patients that appeared critically ill and developed a code team in the outpatient setting

1993-1994, Staff Nurse in Pediatrics, Telemetry, Surgical, ICU Portland Adventist Medical Center, Portland, Oregon

On-Call Staff nurse and float to Pediatrics, Telemetry, Surgial floor and ICU

Provided care to patients with complex conditions. Skills included IV starts and management, EKG interpretation, drug administration and participation on the Code team

1993, Staff Nurse Critical Care Cardiology St. Lukes Medical Center, Phoenix, Arizona

Completed Critical Care Nurse training and preceptorship

Provided care to critically ill patients in the special care unit with a cardiac and vascular focus. Skills included monitoring post surgical cardiac and vascular patients, EKG and strip interpretation, ventilator mangagement, focused patient care plans, and code team.

ACLS Certification

1985-1991 Postions held include the following:

oClaims Analyst II at Blue Cross Blue Shield of Oregon

oBilling Office Manager/Medical Assistant for multi-specialty (Internal Medicine, GI, Cardiology, and Oncology) 6 physician practice

oBilling Manager for Gynecology and Obstestrics office

oMedical Records Clerk for St. Vincents Hospital

oMedical Assistant for Vascular and Trauma Surgeon

HONORS and PROFESSIONAL RECOGNITION

ROSE (Recognize Outstanding Service Excellence) Award, 2006, 2003, 2000 at OHSU

Nursing Foundation Scholarship, 1992

Zelma Gordon Scholarship, 1992

2010-Present, Oncology Nursing Society

2000- Present, Society of Clinical Research Associates

1999-2001, National & Regional Neuromuscular Nurses Advisory Board

LANGUAGES

English (mother tongue)

SELECTED INVITED LECTURES and SHORT COURSES

“Stroke Prevention and Warning Signs” community outreach talk in St. Helena, CA, 2013

“Care of the Stroke Patient”, Versant Nursing Students, 2011-2013

“Consenting Patients”, Study Coordinator Group OHSU 2006

“Warning Signs of Stroke”, Stroke Support Group 2005

“ALS Presentation”, ALS Support Group, 2000

“What you should know about your insurance” ALS Support Group, 1999

“Acute Stroke Care”, Nursing Students, PCC, 1998

“Acute Stroke Care and Current Investigational Protocols” Staff nurses in ICU, ER, Neurology floors for the following institutions:

St. Charles Medical Center, 1998-1999

Tuality Community Hospital, 1998-1999

Salem Hospital, 1998-1999

Rogue Valley Medical Center, 1999

St. Vincents Medical Center, 1998-1999

SELECTED PUBLICATIONS

Fraunfelder F W, Solomon J, Druker B J, Esmaelie B, Kuyl J M

Ocular Side-Effects Associated with Imatinib Mesylate (Gleevec®)

Journal of Ocular Pharmacology and Therapeutics Aug 2003, Vol.19, No.4: 371-375

Egan R A, Kuyl J M, Press R, Lutsep HL.

Lack of Prothrombin Gene Mutation in Young Stroke Patients.

Journal of Stroke and Cerebrovascular Diseases 9:229-231;2000.

MD Nikolaos I.H. Papamitsakis, RN Jennifer Kuyl, MD Helmi L. Lutsep, MD Wayne M. Clark

Benign angioedema after thrombolysis for acute stroke

Journal of Stroke and Cerebrovascular Diseases 9:79-81;2000

Egan RA, Kuyl J M.

Ischemic Stroke in a Man using Estrogen.

Journal of Stroke and Cerebrovascular Diseases. 11: 117-118;2002.

O’Dwyer M E, Mauro MJ, Kuyl J M, Aust S, Paquette R, Sawyers C, Druker B J.

Ongoing evaluation of the combination of Imatinib mesylate (Gleevec®) with low dose Interferon-alpha for the treatment of chronic phase CML.

Blood. 2001; 98:846a (Abstract 3513)

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