Summary
Overview
Work History
Education
Skills
Publications
Awards
Certification
Affiliations
Timeline
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Amy Hamilton

Remotely Based Out Of Longmont, CO

Summary

Full cycle pharmacovigilance professional with extensive experience in safety monitoring and data management. Proven expertise in adverse event reporting, coupled with exceptional customer service skills in study start-up, maintenance, and close-out.

Overview

17
17
years of professional experience
3
3

Certifications

Work History

Safety Monitor and Data Manager

The Emmes Company, LLC
Rockville, MD
01.2021 - 05.2025
  • As Safety Monitor (Feb 2022 – May 2025):
  • Monitored and evaluated clinical trial participant safety for both government- and biopharma-sponsored clinical trials.
  • Analyzed pharmacovigilance data from ad hoc and weekly safety event listings, offered guidance in automated safety query setup, assisted in safety report creation and troubleshooting, and collaborated with data management teams to guide the creation of safety CRFs.
  • Observed trends for any new safety signals and proposed process improvements.
  • Authored and distributed serious adverse event (SAE) narratives ahead of contracted deadlines.
  • Developed and chaired nationwide safety training presentations during clinical trial study start-up, and refresher trainings as needed throughout the life of clinical trials; created presentations for Data Safety Monitoring Board (DSMB) meetings.
  • Reviewed all safety-related study documents throughout the life of the trial.
  • Served as Safety Liaison to technical teams responsible for the roll-out of a new EDC platform, MedDRA/WHO drug coding improvement, and safety reporting improvement initiatives.
  • Coded MedDRA and WHO Drug terms for multiple government and biopharma protocols.
  • As Data Manager (Jan 2021 - Feb 2022):
  • Designed, built, and maintained electronic and paper CRFs; developed and maintained study materials.
  • Performed full-scope data quality activities while serving as the first-line contact for clinical trial sites, addressing site inquiries and concerns with excellent customer service.
  • Issued site guidance communications based on data quality trends to decrease errors and improve data quality.
  • Participated in and led critical study start-up, maintenance, and study close-out data activities.

Clinical Quality Specialist RN

UCHealth
Longmont, CO
05.2019 - 12.2020
  • Served as OPPE and FPPE/Credentialing Support.
  • Abstracted colorectal surgery data for the Colon Bundle Committee and Surgical Center Core Measures data.
  • Committee work: Co-chaired the Venous Thromboembolism (VTE) Committee to track and reduce any VTE incidence; co-chaired the Obstructive Sleep Apnea (OSA) Committee; co-chaired the Enhanced Recovery After Surgery (ERAS) initiative; supported the Peer Review Committee for Medical Staff; supported the Bariatric Surgery Program.

Epic Applications Analyst

Ochsner Health System
Shreveport, LA
04.2018 - 10.2018
  • Obtained certification in EpicCare Inpatient Orders, specializing in order set review and build maintenance.
  • Assisted with on-site Epic changeover and setup for hospitals.
  • Organized yearly Meaningful Use audit binders, ensuring documentation accuracy for audits.

Data Manager and Associate Data Manager

iCardiac Technologies/ERT
Longmont, CO
04.2016 - 04.2018
  • As Data Manager (Nov 2016 – Apr 2018):
  • Specialized in study start-up, maintenance, and close-out data activities for clinical trials.
  • Worked closely with SAS programmers to ensure the complete accuracy of client-facing reports.
  • Generated SAS reports and data transfer files on tight deadlines for top pharmaceutical companies.
  • Collaborated with end user/client on developing documents and files to exact specifications.
  • As Associate Data Manager (Apr 2016 – Nov 2016):
  • Administered edit checks, data changes, writing and resolving data queries, and site/sponsor follow-up.
  • Assisted in developing, updating, and implementing data management procedures, such as incoming data, outgoing data, and data archival processes.

RN Information Analyst / Quality Data Coordinator / Data Abstractor

Boulder Community Health
Boulder, CO
11.2011 - 08.2015
  • As RN Information Analyst (Aug 2014 – Aug 2015):
  • Coordinated hospital and governmental survey submissions to third-party entities to ensure timely reimbursement of hospital funds; collaborated with hospital executives to determine performance improvement focus areas.
  • Validated data and resolved issues, maintained current and past survey and reimbursement documentation.
  • As Quality Data Coordinator and Data Abstractor (Nov 2011 – Aug 2014):
  • Maintained department Core Measure Abstraction data accuracy at 99%; performed detailed chart analysis and information/data gathering, collaborating with third-party vendors to troubleshoot data submissions and ensure the quality of data.
  • Mentored and trained other data abstractors; educated ICU staff regarding core measure requirements per CMS regulations; served as SME to multiple Lean events.

Clinical Outcomes Analyst / Critical Care RN / Nurse Tech

St. Francis Medical Center
Monroe, LA
12.2007 - 10.2011
  • As Clinical Outcomes Analyst (Oct 2009 – Oct 2011):
  • Abstracted 300 charts per month at 98% accuracy and presented data to medical committees within the hospital.
  • Maintained Excel spreadsheets and hospital Core Measure report cards; served as an educational resource for hospital patient safety/Core Measure committees.
  • As Critical Care RN and Nurse Tech (Dec 2007 – Oct 2009):
  • Medical Intensive Care Unit Registered Nurse
  • Prior to BSN graduation, served as Nurse Tech in Endoscopy and Cardiovascular Recovery Unit ICU.

Education

Bachelor of Science - Nursing

University of Louisiana at Monroe
Monroe, LA
05-2008

Master of Arts - French Translation

Monterey Institute of International Studies
Monterey, CA
05-2002

Bachelor of Arts - French

Centenary College of Louisiana
Shreveport, LA
05-1999

Skills

  • Safety monitoring and pharmacovigilance
  • Adverse event and safety reporting
  • MedDRA and WHODrug coding
  • Data analysis and signal detection
  • Process improvement
  • Customer service and support
  • Team collaboration
  • Good clinical practice
  • Analytical thinking

Publications

Greiner, M. G., Shulman, M., Opara, O., Potter, K., Voronca, D. C., Tafessu, H. M., Hefner, K., Hamilton, A., Scheele, C., Ho, R., Dresser, L., Jelstrom, E., Fishman, M., Ghitza, U. E., Rotrosen, J., Nunes, E. V., Bisaga, A., Surmounting Withdrawal to Initiate Fast Treatment with Naltrexone (SWIFT): A stepped wedge hybrid type 1 effectiveness-implementation study., Contemporary clinical trials, 128, 107148, 2023, https://doi.org/10.1016/j.cct.2023.107148

Awards

Runner Up: “Government Study/Team of the Year” (Team Member), 2024 Science Symposium, The Emmes Company, LLC

Certification

CITI (Collaborative IRB Training Initiative) Certified, 2021-Present

MedDRA Coding Certificate, 2022-Present

WHODrug Coding Certificate, 2022-Present

Affiliations

  • Member, The Longmont Chorale and Viva Voce Chamber Choir, 2011-Present
  • Member, Board of Directors, The Longmont Chorale, 2023-Present

Timeline

Safety Monitor and Data Manager

The Emmes Company, LLC
01.2021 - 05.2025

Clinical Quality Specialist RN

UCHealth
05.2019 - 12.2020

Epic Applications Analyst

Ochsner Health System
04.2018 - 10.2018

Data Manager and Associate Data Manager

iCardiac Technologies/ERT
04.2016 - 04.2018

RN Information Analyst / Quality Data Coordinator / Data Abstractor

Boulder Community Health
11.2011 - 08.2015

Clinical Outcomes Analyst / Critical Care RN / Nurse Tech

St. Francis Medical Center
12.2007 - 10.2011

Bachelor of Science - Nursing

University of Louisiana at Monroe

Master of Arts - French Translation

Monterey Institute of International Studies

Bachelor of Arts - French

Centenary College of Louisiana

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Amy Hamilton