Amelia Foster
Atlanta,GA
Summary
Strategic and performance-driven Clinical Operations Manager with over a decade of progressive experience in global clinical trial operations, site management, and vendor oversight across Phases I–III. Proven track record in leading high-performing teams, optimizing operational workflows, ensuring regulatory compliance (ICH/GCP), and delivering high-quality data on time and within scope. Adept at managing cross-functional teams, implementing quality control measures, and driving continuous improvement in complex clinical environments.
Overview
14
14
years of professional experience
Work History
Clinical Operations Manager II
Fortrea (formerly LabCorp/Covance)
Atlanta, GA
08.2020 - 08.2024
- Oversaw daily operations and performance for a team of 14–16 CRAs, ensuring compliance with KPIs, training requirements, SOPs, and ICH/GCP standards.
- Led FSP oversight, resource alignment, and cross-functional project coordination across multiple therapeutic areas and global studies.
- Directed operational strategy, including data quality review, risk mitigation, and audit readiness to support database lock and submission timelines.
- Conducted monitoring quality control (MQC) assessments to maintain GCP compliance and evaluate CRA performance.
- Facilitated onboarding enhancements and streamlined access processes to accelerate operational readiness for new hires.
- Delivered regular performance reviews and led professional development initiatives through one-on-one coaching and team training.
- Partnered with vendors and study leadership to ensure seamless site management and protocol compliance.
Sr. Clinical Research Associate II
Fortrea
Atlanta, GA
05.2018 - 08.2020
- Performed all phases of site monitoring visits (PSV, SIV, IMV, COV), ensuring compliance with clinical trial protocols, regulatory requirements, and GCP standards.
- Validated CRFs and conducted source data verification, ensuring data accuracy and query resolution in a timely manner.
- Oversaw AE/SAE documentation, ensuring patient safety and regulatory adherence.
- Trained site staff on study protocols, EDC systems, and GCP guidelines, improving data entry accuracy and protocol compliance.
- Supported inventory and supply chain management of clinical trial materials across sites.
- Mentored junior CRAs and contributed to quality improvement initiatives within the monitoring team.
Clinical Research Associate II
ICON Plc
Atlanta, GA
05.2015 - 03.2018
- Monitored up to 25 sites across 3 protocols in Cardiovascular, CNS, Dermatology, and Respiratory therapeutic areas.
- Conducted remote and on-site monitoring visits, verifying subject data, managing deviations, and supporting query resolution.
- Delivered sponsor reports on enrollment progress, site performance, and data quality metrics.
- Ensured ongoing site GCP compliance through training and re-training initiatives.
- Used CTMS and EDC systems to document visit outcomes and track deliverables.
Clinical Research Associate
Worldwide Clinical Trials
Atlanta, GA
04.2013 - 05.2015
- Oversaw 12–14 study sites for respiratory and vaccine clinical trials; ensured protocol adherence, timely data entry, and site compliance.
- Designed and implemented recruitment and enrollment strategies in collaboration with site staff.
- Verified CRF entries and coordinated with data management to resolve discrepancies.
- Scheduled site visits and managed sponsor documentation requirements per monitoring plan.
Clinical Research Associate I
Inventiv Health
Atlanta, GA
01.2011 - 03.2013
- Conducted routine monitoring to ensure protocol compliance and subject safety in active studies.
- Reported AEs/SAEs and maintained accurate documentation for regulatory audits.
- Tracked subject enrollment and study milestones across assigned sites.
Education
Bachelor of Science -
Alabama State University
Montgomery, ALSkills
Clinical Trial Oversight (Phase I–III) - Global Study Execution - Functional Service Provider (FSP) Management - Clinical Data Integrity & Review - Risk-Based Monitoring (RBM) - KPI/Metrics Monitoring & Reporting - Audit Readiness & CAPA Implementation - Site Selection - Initiation & Close-Out - Cross-Functional Leadership & Stakeholder Engagement - Vendor & CRO Oversight - Quality Control (QC) & Monitoring Plans - SOP Development & Process Optimization
Therapeutic Areas
Dermatology: Psoriasis, Respiratory: COPD, Transplant Device, Cardiometabolic: Hypertension, Hyperlipidemia, Diabetes, Neurology: Progressive Supranuclear Palsy (PSP), Infectious Disease: Influenza, HPV, Vaccines, Pain Management: Endometriosis
Timeline
Clinical Operations Manager II
Fortrea (formerly LabCorp/Covance)
08.2020 - 08.2024
Sr. Clinical Research Associate II
Fortrea
05.2018 - 08.2020
Clinical Research Associate II
ICON Plc
05.2015 - 03.2018
Clinical Research Associate
Worldwide Clinical Trials
04.2013 - 05.2015
Clinical Research Associate I
Inventiv Health
01.2011 - 03.2013
Bachelor of Science -
Alabama State University
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