Amy Moore
Smithfield
Summary
Dedicated Clinical Research Professional with 8 years of combined experience in clinical trial monitoring and on-site oncology research, supported by a Bachelor's Degree in Clinical Research. Skilled in study management, regulatory compliance, site relationships, and patient-centered research. Seeking to contribute strong organizational abilities, attention to detail, and a passion for improving patient outcomes within a strong clinical research organization.
Overview
8
8
years of professional experience
Work History
Site Navigator II
Fortrea
Durham, NC
02.2026 - 06.2026
- Oversight of site-level tasks for efficient site activation.
- Identify research sites aligning with study criteria, conduct site outreach and feasibility.
- Perform On-site and Remote Pre-Study Visits and documentation.
- Collect, track, and review essential documents for activation.
- Perform remote and on-site visits as required by the monitoring plan including Routine Monitoring Visits, Site Initiation Visits, and Close-Out Visits that may be required.
- Acts as a knowledge resource to mentor and train junior colleagues.
- Complete monitoring visit documentation including visit reports, cost analyses, travel documentation, and issue and risk management reports.
In-House Clinical Research Associate II
Fortrea
Durham, NC
08.2021 - 02.2026
- Conducted site selection, initiation, close-out, and monitoring visits to ensure compliance with study protocols and document all progress and findings.
- Collaborated with cross-functional teams to develop study materials and project timelines.
- Trained junior staff on standard operating procedures and best practices in clinical research.
- To serve as contact for project team and investigative sites, conduct site contacts and document contacts for assigned sites as required per study guidelines.
- To monitor site performance and implement action plans for sites not meeting expectations.
- To collaborate with project team and study sites during recruitment phase, tracking, patient recruitment by contacting investigators as specified for the study and identify potential study risks and opportunities.
- To assist CRAs with preparation for site visits (i.e., running reports, QC of files (checking for missing documents), resolving action items from previous visits) and co-monitor.
- To provide oversight and management of maintenance activities; to ensure compliance with renewals, document and update according to applicable local regulatory and IRB/IEC requirements.
- To perform Case Report Form review, query generation and resolution against established data review guidelines.
- To undertake other project related administrative tasks (i.e. recruitment tracking, site document preparation) as appropriate
Oncology Clinical Research Specialist
UNC Rex Healthcare
Raleigh, NC
06.2020 - 08.2021
- Screened patients for potential clinical trials.
- Collaborated with multiple departments for specimen management.
- Aided in hiring and training new employees.
- Inputted research patient data into a variety of data capturing systems.
- Worked with outside agencies on monitoring visits, data and query resolution.
- Led hospital work engagement projects for research team.
- Coordinated patient care across multiple sites and departments.
- Trained and worked on a variety of oncology trials composing of both solid tumors and hematologic disease.
- Represented the department in the Team STEPPS program to promote process improvements throughout the clinic.
- Consented and enrolled patients onto clinical trials and managed assigned studies as Lead Coordinator.
Oncology Clinical Research Associate
UNC Rex Healthcare
Raleigh, NC
06.2018 - 06.2020
- Managed and entered data for over 35 studies by using data capturing systems.
- Prepared and shipped biospecimens for research patients.
- Connected with research personnel to complete team projects.
- Built excel spreadsheets to use for audits and everyday study use.
- Created process improvements used by multiple departments.
- Promoted a positive work environment with co-workers and patients.
- Planned and prepared for research monitoring visits with outside sponsors.
- Trained co-workers on using different databases and Microsoft elements.
- Oriented and trained new team members.
- Assisted physicians with electronic data capturing and training systems, consented and enrolled patients to the biospecimen banking study.
Oncology Clinical Research Intern
UNC Rex Healthcare
Raleigh, NC
01.2018 - 05.2018
- Created source documents for the research and pharmacy departments.
- Reviewed patient charts and data in for audits and quality assurance.
- Trained in a variety of electronic data capturing systems.
- Collaborated with research staff for projects and tasks.
Education
Bachelor of Science - Clinical Research
Campbell University
Buies Creek, NC05-2018
Minor - Biological Sciences
Campbell University
Buies Creek, NC05-2018
Minor - General Sciences
Campbell University
Buies Creek, NC05-2018
Skills
- Site management
- Detailed documentation
- ICH-GCP guidelines
- Electronic data capture
- Site monitoring
- Regulatory management
- Patient safety
- Informed consent process
- Clinical data management
Systems Experience
- CTMS: 5 years
- Unified Clinical Vault (Veeva): 5 years
- iMedidata RAVE: 9 years
- Inform version 4.0: 7 years
- Inform version 6.0: 9 years
- OnCore: 7 years
- Florence: 7 years
Timeline
Site Navigator II
Fortrea
02.2026 - 06.2026
In-House Clinical Research Associate II
Fortrea
08.2021 - 02.2026
Oncology Clinical Research Specialist
UNC Rex Healthcare
06.2020 - 08.2021
Oncology Clinical Research Associate
UNC Rex Healthcare
06.2018 - 06.2020
Oncology Clinical Research Intern
UNC Rex Healthcare
01.2018 - 05.2018
Bachelor of Science - Clinical Research
Campbell University
Minor - Biological Sciences
Campbell University
Minor - General Sciences
Campbell University