Elizabeth B. Stewart

Phone: 805-***-**** (C) E-Mail: acxu9i@r.postjobfree.com

A results oriented, self-motivated healthcare specialist. I have over eight years of experience working for a CRO in both clinical trial and post marketing areas, most recently working in early development clinical trials. I am open to relocation and willing to travel, as needed.

Summary of Qualifications

Extensive experience with processing Serious Adverse Events, Non-Serious Adverse events, writing narratives and queries within database applications, including Argus 7.1, RAVE, EDC, ArisG, and CRF.

Strong knowledge of medical coding using MedDRA and WHOOD applications, pharmacovigilance and regulations, safety management plans, aggregate safety reporting, and clinical development.

Significant and varied therapeutic experiences including Oncology, Psoriasis, Nephrology, Women’s Health, CNS Psychiatry, Dermatology and Inflammatory Diseases.

Extensive knowledge ICH and GCP guidelines.

Managerial experience in leading a team of drug safety associates.

Experience

Sarah Cannon Research Institute, Nashville, TN 2016- Current

Clinical Trials Specialist I

Accountable for the execution of clinical trials for the research team.

Managed the collection and completion of data entry into study specific case report forms or electronic data capture systems within 10 days of patient’s visits.

Successfully confirmed patient eligibility, based on protocol inclusion/exclusion, and verify screening procedures are performed within the protocol specified window.

Communication in weekly teleconference calls with sponsors on patient updates including any significant toxicities, responses, cohort openings, number of slots allocated to site.

Responsible for following patient’s response to study drug according to RECIST criteria in real time to assist in treatment decisions.

INC Research, LLC Raleigh, NC 2008 – 2015

Safety Data Coordinator II

Responsible for clinical reporting on new proprietary drug formulations. This involves the creation, review, and submission of aggregate reports (ASRs, IND annual reports, and ad hoc) to Ethics Committees and Regulatory Authorities.

Successfully builds databases, based on sponsored study source documents for proprietary drug trials, as required for SAE tracking and reconciliation in accordance with their specific guidelines and company standards. Experienced in working with standard source documents and also source documents containing patient’s medical records and published medical articles.

Interacts with sponsors and investigators to ensure accurate data collection. This includes trial sites in North America and Europe.

Constructs written narratives for proprietary oncology and nephrology drugs summarizing all adverse events, determined seriousness, expectedness, reported causality and event resolution.

Based on person performance, chosen for performing QC on colleagues’ data entry and narratives to ensure corporate, sponsor, and regulatory compliance.

Salem Communications, Camarillo, CA 2005 – 2007

Investor Relations Coordinator

Responsible for a variety of key investor functions, including preparing IR presentations and press releases.

Developed marketing materials for prospective and current shareholders.

Primary point of contact for inquiries received via Investor Relations hotline.

Developed relationships with COO, station directors, and media outlets.

The Cheesecake Factory, Calabasas Hills, CA 2005

Relocation Associate

Managed all aspects of the relocation of more than 40 employees.

Accountable for ensuring that all employee relocation expenses met Corporate guidelines.

Developed and implemented new procedures for employee relocations and temporary housing for managers. These procedures became the company’s standard.

Amgen Inc. Thousand Oaks, CA (Contracted) 2003 – 2005 Communications Coordinator

Performed Media Monitoring utilizing in-house developed software.

Responsible for managing the organization of the Corporate Communications library and its content.

Developed and implemented processes to improve the effectiveness of the Corporate Communications organization.

Active member of the Amgen Newswire Team.

Hyatt Regency, Atlanta GA 2002 – 2003

Convention Services Associate

Point of contact for prospective client inquiries.

Developed Convention Services Marketing materials and packages.

Responsible for preparing contract proposals for scheduled hotel functions.

Simply Health, Atlanta GA 2000 – 2002

Project Coordinator/Implementation Analyst

Internal project leader for new carrier implementations, including BCBS and United, and successfully managed their implementation schedules.

Trained senior level healthcare managers on web enabled products.

Managed all data for the providers on the web site, including QA prior to uploading.

Responsible that client changes/ updates in coverage, rates, and offerings were correctly reflected on web site, in brochures, and on insurance applications.

Education

University of Alabama, Tuscaloosa, AL 1996 - 2000

Bachelor of Science, School of Commerce and Business Administration Major in Health Care Management

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