Debra Goodwin Email & Phone Number

Greensboro, Georgia, United States

Kenosha

Strategic Health Care Planning and Evaluation

Kenosha, Wisconsin

Undergraduate/Graduate• Legal and Ethical Issues for Health Care Professionals -Since 2014• Health Service Administration Practicum – Since 2015• Health Care Planning and Evaluation – Since 2015• Management Principles in Health Care -Since January 2018

North Chicago, Illinois

Process Improvement Nurse Consultant/Coordinator.Responsible for providing the clinical leadership and expertise for the planning, designing, integrating, implementing, modifying and evaluating the requirements of internal and external agencies. • Responsible for monitoring, trending and analyzing data related to The Joint Commission standards, interprets VA handbooks and directives regarding Quality Management/Performance Improvement/Patient Safety issues; Collaborates with FHCC Patient Safety Officer.• Possesses knowledge and experience related to the Joint Commission (TJC), Commission on Accreditation of Rehabilitation Facilities (CARF), Long Term Care Institute (LTCI), Office of Inspector General (OIG), Department of Defense (DoD), Navy, Bureau of Medicine and Surgery (BUMED) and other internal and external agency regulations and requirements.• Consultant for Patient Aligned Care Team (PACT), Womens Health, Family Practice/Internal Medicine, Pediatrics and Specialty clinics, Community-Based Outpatient Clinics (CBOCs), surgical clinics, Ophthalmology and Geriatrics and Extended Care (GEC).• Assist and conduct investigations for risk management cases.• Member of the Women Veterans Program.• Conduct risk assessments in all service areas.• Consultant on Root Cause Analysis’ (RCAs) for all service areas which includes: clinics and GEC.• Provide training and support for new Administrative Investigative Board (AIB)team members.• Conduct investigations and follow-up reports on tort claims. • Responsible for the planning and implementation for the new electronic Patient Event Reporting system (ePERs) for FHCC and NAVY Medicine East • Responsible for Medical Residents' in-services and training on health care performance improvement activities.• Integrated Ethics Consultant• Active Member of the Advisory Board for Life Sustaining Treatment Decisions• Lean Six Sigma-Greenbelt trained (Certification pending)

Orlando, Florida

Deerfield, Illinois

Drug Safety Analyst (Contract)​January 2012 – March 2013Advanced Clinical / Randstad / MedFocus​Full-time (40 hour/week)On-site at Hospira (1/2013- 3/2013)• Quality Control (QC) of narratives for MEDWATCH Form 3500A using MedDRA coding. Conduct periodic Safety Update Reports (PSUR) for Hospira’s marketed drugs. Review of Core Safety Information (CSI). Review of medical assessments for root cause analysis, adverse events and resolution.On-site at Takeda Pharmaceuticals​(7/2012 – 10/2012)• Provided operational support to pharmacovigilance departments; supported activities which included the following areas:Data entry, compliance, reporting and metrics, regulatory submissions, and document management. International data from clinical studies, post-marked drugs and compounds were formatted for Argus to be uploaded to ARISg. On-site at Abbott (2/2012 – 5/2012)• Responsibilities included medical review, which involved in-house review of Case Report Forms (CRFs) .depth investigation of medical adverse events in the preparation for submission to FDA. Responsible for serious adverse events and CRF completion, writing study summaries, and review protocols, study summary investigator brochures and IND annual updates for safety data verification.

Deerfield, Illinois

Responsibilities included medical review, which involved in-house review of Case Report Forms (CRFs) including query resolution and addenda writing, QA of data listings. Provided medical support which included: Adverse Event Reporting - the investigation and reporting of medical product experiences, in depth investigation of medical adverse events in the preparation for submission to FDA. Responsible for serious adverse events and CRF completion, writing study summaries, and review protocols, study summary investigator brochures and IND annual updates for safety data verification.

Deerfield, Il

Provide operational support to the pharmacovigilance department. Supporting activities that include following areas: data entry, compliance, reporting and metrics, regulatory submissions, and document management. Activities tied with strict time lines and specific procedures. Analyze/resolve complex problems with minimal supervision and understand when to escalate issues.

St Luke'S Medical Center

Neuroscience section of Division of Patient Centered ResearchPerforms clinical and administrative coordination of clinical trials for pharmaceutical companies, device manufacturers, cooperative groups and in-house trials. Works closely with investigators to recruit eligible subjects to studies and acts as the primary contact person during the collection of data for the research study. Maximizes enrollment in clinical trials through effective recruitment strategies. Prepares and submits regulatory document for submission to the IRB.

Bsn, Registered Nursing/Registered Nurse

Master Of Arts (Ma), Health Care Administration/Management