Jackie Edwards
STANARDSVILLE,VA
Summary
Principal Clinical Research Associate with over 20 years in industry in different positions, including Clinical Research Associate, Lead CRA, Clinical Manager, Clinical Team Leader, Project Manager, Manager of Drug Safety and Clinical Scientist. Worked on over 80 clinical trials in different therapeutic areas and gained significant experience in Hematology/Oncology clinical trials including Solid Tumors during which mentored junior CRAs and supported project management with assigned tasks and reviewed monitoring reports. Managed a Drug Safety department with up to 18 staff, delegating tasks, coding, and reconciliation of study data bases. Performed all types of on-site and remote Monitoring Visits: PSV, SIV, IMV and COV with 100% or reduced SDV and rSDR. Used different clinical and/or client specific systems for trial management, such as EDC, CTMS, IVRS, IWRS, eDiaries and participated in several site audits, local authority inspections and supported investigative site in preparation for an FDA inspection.
Overview
8
8
years of professional experience
Work History
Principal CRA
PPD
04.2023 - Current
- Principal Clinical Research Associate performs, and coordinates assigned aspects of Clinical monitoring process in accordance with GCPs and global SOPs to assess safety and efficacy of Investigational products and/or medical devices
- Conducts site visits to determine protocol and regulatory compliance and prepares required documentation
- Develops collaborative relationships with investigative sites and client company personnel.
Senior CRA II
Covance/LabCorp
12.2020 - 04.2023
- Senior Clinical Research Associate on (6) clinical trials in Oncology.
- (Pancreatic Cancer Phase 1b, II and III phase), Open label in 350 subjects
- Lung Cancer Phase II and III, Double blind, 280 subjects
- Performs, and coordinates assigned aspects of Clinical monitoring process in accordance with GCPs and global SOPs to assess safety and efficacy of Investigational products and/or medical devices
- Conducts site visits to determine protocol and regulatory compliance and prepares required documentation
- Develops collaborative relationships with investigative sites and client company personnel.
Clinical Team Leader
Covance
01.2020 - 12.2020
- Clinical Team Leader on (4) clinical trials in Oncology
- (Lung and Brain Cancer Phase II and III, Randomized in 420 subjects
- Responsible and accountable for management of clinical operations team with emphasis on teamwork, quality, timelines, budget, metrics and compliance within project plans and SOPs.
Senior Clinical Team Leader
Chiltern/Covance
06.2016 - 12.2019
- Senior Clinical Team Leader was responsible and accountable for management of clinical operations team with emphasis on teamwork, quality, timelines, budget, metrics and compliance within project plans and SOPs.
Education
Master of Science - Health Administration
University of Phoenix
Tempe, AZ2008
Bachelor of Science - Health Administration
Old Dominion University
Norfolk, VA2003
Associate of Science - Registered Nursing
Cerritos College
Norwalk, CA01.1991
Additional Relevant Experience
- Audit Experience
- Investigator-Site Audit, Sponsor, CTL and CRA
- TMF-Audit, Sponsor, CTL and CRA
- Computer Experience
- EDC (Inform, RAVE Medidata)
- ETMF, EMR (various), CTMS
Affiliations
Member of the Association of Clinical Research Professionals, Alexandria, VA, USA since 2005
Therapeutic Experience And Expertise
- Allergy: Allergic Rhinitis
- Cardiology/Vascular Diseases: Atherosclerosis (Ph I), Stoke, Heart Failure
- Dermatology: Eczema, Rosacea, Cellulitis
- Devices: Wound care, Influenza injection systems
- Endocrinology/Metabolic Diseases: Diabetes Mellitus Type I (Pediatric), Diabetes Mellitus Type II, Obesity, Dyslipidemia
- Genitourinary: Women's health, Men's health
- Hematology/Oncology: Leukemia (ALL, CLL, CML, AML), Lymphoma (Non-Hodgkin's, Hodgkin's), Lung cancer (SCLC and NSCLC), Solid tumors, Melanoma, Myelodysplasia, Prostate cancer, Pancreas cancer, Breast cancer, Brain cancer, Ovarian cancer, Liver cancer, Anemias, Mucositis, Cancer related pain
- Infectious/Parasitic Diseases: Pneumonia (CABP, HAP/Ventilator acquired), Influenza, Cytomegalovirus
- Nervous System: Neuropathies/Neuropathic Pain (Peripheral, Diabetic), Epilepsy, Arthritic Pain (hip and/or knee)
- Psychiatry/Psychology/Mental Disorders: Depression, Eating disorders
- Rare/Genetic Diseases/Disorders: Cystic Fibrosis
- Respiratory: Asthma, Chronic Obstructive Pulmonary Disease
- Transplants: GvHD (Adult and Pediatric)
- Vaccine: Influenza
Personal Information
Title: RN, MHA, CCRA
Timeline
Principal CRA
PPD
04.2023 - Current
Senior CRA II
Covance/LabCorp
12.2020 - 04.2023
Clinical Team Leader
Covance
01.2020 - 12.2020
Senior Clinical Team Leader
Chiltern/Covance
06.2016 - 12.2019
Master of Science - Health Administration
University of Phoenix
Bachelor of Science - Health Administration
Old Dominion University
Associate of Science - Registered Nursing
Cerritos College