Angeli Burgos
Buford,GA
Summary
Results-driven Clinical Research Professional with over 4 years of progressive experience in clinical trial management, regulatory compliance, and site operations. Proven expertise in managing multi-phase clinical trials, ensuring GCP compliance, and leading cross-functional teams. Demonstrated ability to optimize site performance, maintain regulatory standards, and enhance patient recruitment and retention. Seeking to leverage comprehensive clinical research knowledge and leadership experience to excel as a Site Manager.
Overview
4
4
years of professional experience
6
6
Certifications
Work History
Clinical Research Coordinator II
Avacare Research/IQVIA
Lilburn, GA
05.2024 - Current
- Coordinated Phase I-III clinical trials across rheumatology, infectious disease, respiratory, and medical device sectors.
- Ensured compliance with FDA regulations, GCP guidelines, and sponsor protocols, enhancing integrity of multiple concurrent trials.
- Managed site initiation, monitoring visits, and close-out activities as primary liaison among sponsors, CRAs, and internal teams.
- Maintained accurate source documentation and completed electronic data capture on time, supporting adherence to all sponsor deadlines.
- Supervised drug accountability, inventory management, and pharmacy operations, optimizing workflow using IXRS systems and eISF/CTMS platforms.
- Trained new coordinators on GCP compliance and protocol adherence to foster excellence.
- Achieved 98% query resolution rate while maintaining zero major findings during monitoring visits
- Implemented process improvements that boosted patient recruitment by 25% and enhanced data quality metrics.
Clinical Research Coordinator/Phlebotomist
Accel Research Sites/NeuroStudies
Decatur, GA
01.2022 - 11.2023
- Coordinated Phase I-IV clinical trials in neurology, infectious disease, and cardiology, managing patient enrollment and retention activities.
- Ensured scientific integrity of data collection and safeguarded patient rights and welfare per ICH-GCP standards.
- Executed electronic data capture (EDC) accurately, meeting sponsor timelines and maintaining source documentation.
- Performed clinical procedures such as venipuncture, EKGs, vital signs, and protocol-specific assessments.
- Managed regulatory documentation, including 1572 forms and Investigator Site Files, ensuring compliance with regulations.
- Managed investigational product accountability, ensuring proper dispensing and administration according to pharmacy regulations.
- Collaborated with CRAs to address monitoring findings and ensure adherence to study protocols.
- Participated in Site Initiation Visits (SIV) and regulatory audits, achieving zero critical findings.
Certified Pharmacy Technician
Apotheco Pharmacy
Lawrenceville, Georgia
09.2021 - 01.2022
- Managed pharmacy operations, ensuring accurate medication compounding and efficient inventory management.
- Maintained accurate medication records to ensure compliance with state and federal regulations.
- Executed regulatory compliance measures to maintain pharmacy standards and meet legal requirements.
- Addressed complex insurance claims and third-party billing issues, enhancing resolution processes through effective problem-solving.
Education
Bachelor of Science - Neuroscience
Georgia State University
Atlanta12-2023
Skills
- Clinical Trial Management
- Regulatory Compliance & Audits
- Good Clinical Practice (GCP)
- Team Leadership & Training
- Protocol Development & Implementation
- Data Quality & Integrity Management
- Investigator Site File (ISF) Oversight
- Budget & Resource Management
- CRA & Sponsor Relations
- Patient Recruitment & Retention
- eTMF/CTMS/EDC Systems
- SOP Development & Implementation
Key Achievements
- Recognized as top enrolling site on the east cost, contributing 25-30% of total study participants across multiple trials
- Recognized by CRAs and sponsors for exceptional data quality and attention to regulatory detail
- Utilized bilingual recruitment materials and processes that increased enrollment of Hispanic/Latino populations by 30%
- Achieved 98% query resolution rate and maintained zero major findings during monitoring visits and sponsor overview
Areas of Expertise
Indications:
- Neurology: Phase II-III: Alzheimer's Disease, Parkinson's Disease, Neuropathy and Migraines
- Cardiovascular: Observational and Phase I-III: Hypertension, Obesity, Coronary Artery Disease
- Respiratory: Phase III: Pulmonary Arterial Hypertension
- Rheumatology: Phase III: Gout
- Infectious Disease and Rare Disease: Phase I-III: COVID-19, Influenza, Equine Encephalitis Virus
- Medical Device Trials: COVID-19, Influenza, and Atrial Fibrillation
- Neuropsych Assessments: MMSE, C-SSRS, PHQ-9, MOCA, and ADAS-Cog
- Specimen Processing and Laboratory Shipments
- Unblinded Investigational Product Dispensing and Administration
- Regulatory and Safety Compliance: GCP/ALCOA+, IATA, OSHA, and IBC
Languages
English
Native/ Bilingual
Spanish
Native/ Bilingual
Certification
Pharmacy Technician Certification
Timeline
Clinical Research Coordinator II
Avacare Research/IQVIA
05.2024 - Current
Clinical Research Coordinator/Phlebotomist
Accel Research Sites/NeuroStudies
01.2022 - 11.2023
Certified Pharmacy Technician
Apotheco Pharmacy
09.2021 - 01.2022
Bachelor of Science - Neuroscience
Georgia State University