Amber Hickman
Gallatin,Tennessee
Summary
Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.
Overview
8
8
years of professional experience
Work History
Site Management Associate
ICON Clinical Research
02.2023 - Current
- Specifically trained in many late phase research study designs. Direct late phase study design experience in patient registries. Responsibilities include remote clinical monitoring, site participant recruitment, site start up activities, essential document collection (GCPs, License, Trainings etc.) and review, regulatory submissions, site management, and data review.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Managed over 1,200 sites with constant communication to each site and Principal Investigator.
- Followed drug storage procedures to comply with protocols and SOP requirements.
- Reviewed data queries and listings and worked with study centers to resolve data discrepancies.
- Submitted routine confirmation letters, site initiation visit reports and follow-up letters to facilitate internal and external communication.
- Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.
- Liaised with clinical investigator to identify, assess and resolve site performance, quality and compliance issues.
- Created and updated records and files to maintain document compliance
In-House Clinical Research Associate
ICON Clinical Research
06.2021 - 02.2023
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Adhered to procedures, practices and regulatory requirements to maintain health, safety and environmental compliance.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
- Reviewed data queries and listings and worked with study centers to resolve data discrepancies.
- Supported development and delivery of department training to maximize success of clinical research.
- Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.
- Liaised with clinical investigator to identify, assess and resolve site performance, quality and compliance issues.
- Set up and disbanded trial study centers to manage clinical study activities for 1,251 sites
Clinical Trial Assistant
ICON Clinical Research
07.2019 - 06.2021
- Worked with collaborative and successful teams on a daily basis to support clinical trial management, project management, and CRA teams as well as sites and vendors with operational activities.
- Provided administrative support to various projects, maintained and tracked clinical study documentation and collected relevant study information.
- Maintained and oversaw study files in the Trial Master File.
- Coordinated blast emails.
- Prepared sponsor meeting agendas and distributed to each team.
- Participated in study meetings, completed meeting minutes, and distributed finalized minutes to each team.
- Monitored study status through reports and trackers.
- Monitored queries and followed-up with sites
- Granted vendor access to study teams and site members.
- Performed other duties as assigned
Analytical/Biochemist
Aegis Sciences Corporation
05.2018 - 07.2019
- Developed methods; performed wet chemistry, sample preparation and data analysis; and operated UHPLC and LC-qTOF-MS for “Identifying Fentanyl Analogs in Heroin-Positive Urine by LC-qTOF-MS” presentation and poster session.
- Analyzed and identified various substances utilizing chemical testing and instrumentation, including EVO and LCMS, while complying with all laboratory safety, quality procedures and requirements.
- Operated, troubleshooted and maintained a variety of laboratory equipment, including ELISIA and EIA, reviewing and verifying instrumentation data for acceptable results.
- Ensured that appropriate reference materials (calibrators, controls) are included in each batch/sample analysis and meet acceptable criteria. Prepared QC materials as directed and needed, documented and maintained accurate instrument, reagent and QC records per standard operating procedures and regulatory requirements.
- Maintained chain of custody reports throughout collections.
Internship Student
Hendersonville Police Department
01.2016 - 05.2016
- Completed 320 hours patrolling neighborhoods, conducting traffic stops, being dispatched to calls, learning dispatch positions, taking new recruit classes, going to the gun range and spending time in the criminal investigations division looking at reports of various criminal activity along with performing fingerprinting techniques.
Education
No Degree - Forensic Medicine
University of Florida
Gainesville, FL08.2024
Bachelor of Science - Forensic Science
Middle Tennessee State University
Murfreesboro, TN08.2019
Bachelor of Science - Criminal Justice
Middle Tennessee State University
Murfreesboro, TN08.2019
Associate of Applied Science - Police Science/Crime Scene Investigation
Nashville State Community College
Nashville, TN05.2011
Skills
- Microsoft Excel
- Microsoft Office
- Microsoft Outlook
- Microsoft Windows
- Microsoft Word
- Risk Mitigation Strategies
- Following Sops
- Monitoring Plans
- Site Selection
- Clinical Research Monitoring
- Research and Development
- Research Sops Understanding
- Complex Problem-Solving
- Time Management
- Good Clinical Practice
- Troubleshooting
- Drug Storage Procedures
- Site and Study Management
- Critical Thinking
- Report Writing
- Team Training
- FDA Compliance
- Microsoft PowerPoint
- Creative Thinking
Accomplishments
- Rated highly successful performer by peers and stakeholders.
- Received 15 inspire awards.
- Recognized as study of the quarter for 4 different studies due to diligent planning, as well as continuous site engagement, creativity, patient-centric recruitment approaches, demonstrated a strong sense of collaboration by implementing a culture of persistence and determination and obtaining a strong relationship with the sponsor and vendor teams.
- Recognized as employee of the year for my work commitment, respect, and teamwork.
- Recognized as employee of the month for possessing a positive attitude and showing passion for my job.
Timeline
Site Management Associate
ICON Clinical Research
02.2023 - Current
In-House Clinical Research Associate
ICON Clinical Research
06.2021 - 02.2023
Clinical Trial Assistant
ICON Clinical Research
07.2019 - 06.2021
Analytical/Biochemist
Aegis Sciences Corporation
05.2018 - 07.2019
Internship Student
Hendersonville Police Department
01.2016 - 05.2016
No Degree - Forensic Medicine
University of Florida
Bachelor of Science - Forensic Science
Middle Tennessee State University
Bachelor of Science - Criminal Justice
Middle Tennessee State University
Associate of Applied Science - Police Science/Crime Scene Investigation
Nashville State Community College