Amanda Atunzu
IQVIA Biotech
Atlanta,Georgia
1
Certification
14
years of professional experience
Senior Clinical Research Associate overseeing sponsor-side monitoring quality, reviewing 5+ monitoring reports per month across ICH-GCP compliance, CRO oversight, and EDC review. Manages protocol deviation trending, query resolution, CAPA follow-up, and eTMF documentation to support inspection readiness and database lock. Brings a monitoring style built around site performance, data integrity, and fast issue escalation.
Work History
Senior Clinical Research Associate
4 Months- Reviewed 5 monitoring reports weekly to identify recurring quality gaps and support corrective actions.
- Provided sponsor-side oversight of CRO monitoring activities in line with ICH-GCP, protocol, and regulatory requirements.
- Supported CAPA implementation to strengthen monitoring quality and address trends identified in review findings.
- Acted as a liaison between sponsor and CRO teams to resolve issues and keep monitoring communications aligned.
- Manage assigned investigated sites, ensuring timely study execution and achievement of milestone.
- Utilize Veeva Vault, EDC, IRT, and clinical trial system to track site activities, data quality, and study progress.
Senior Clinical Research Associate | In-House Clinical Research Associate
4 Months- Reviewed 7 monitoring reports weekly to identify recurring quality gaps and support corrective actions.
- Provided sponsor-side oversight of CRO monitoring activities in line with ICH-GCP, protocol, and regulatory requirements.
- Supported CAPA implementation to strengthen monitoring quality and address trends identified in review findings.
- Acted as a liaison between sponsor and CRO teams to resolve issues and keep monitoring communications aligned.
- Coordinated eTMF documentation and IP accountability with CRO and CTA teams to support inspection readiness.
Clinical Site Ambassador | Senior Clinical Research Associate
3 Years 11 Months- Developed monitoring tools and templates that reduced report turnaround time by 30% and improved documentation quality.
- Managed 10-15+ investigative sites from feasibility through closeout while maintaining full ICH-GCP compliance.
- Strengthened site relationships to improve enrollment performance and reinforce site compliance across active studies.
- Delivered site training and protocol education to support adherence, reduce protocol deviations, and maintain audit readiness.
- Mentored Junior CRAs and supported co-monitoring activities to strengthen consistency across site visits.
- Supported study startup management and site activation management through cross-functional collaboration and timely issue escalation.
Senior Clinical Research Associate
1 Year 11 Months- Conducted SDV and SDR across rare disease, neurology, and oncology trials to maintain protocol compliance and data integrity.
- Coordinated SAE reporting with Medical Monitors and Regulatory teams to support timely submission and issue escalation.
- Supported IRB and EC submissions while coordinating vendors to help keep study timelines on track.
Clinical Research Associate II| Clinical Research Associate | Clinical Trial Assistant
6 Years 4 Months- Prompted twice within the organization based on strong performance and monitoring expertise.
- Conducted full life-cycle monitoring visits (PSSV, SIV, IMV, COV) across multiple therapeutic areas.
- Managed site performance and regulatory documentation, and ensured ICH-GCP compliance.
- Supported SDV/SDR, data review, and query resolution to maintain data integrity.
- Maintained audit-ready TMF/ISF documentation and supported inspection readiness.
- Collaborated with cross-functional teams to ensure milestone delivery.
Education
Bachelor of Science - Health Science
GPA: 3.6
Skills
Clinical trial execution
CTMS management
Site monitoring & management
EDC system management
CRO oversight & vendor management
Patient enrollment & retention strategies
Investigator & site relationship management
EDC review & query management
ICH-GCP compliance
Audit readiness
CAPA development
Protocol deviation management
Informed consent review
Issue escalation
Cross-functional collaboration
Sponsor communication
CRA training & mentoring
Risk mitigation
Study startup management
Feasibility assessment
Site activation management
Risk-based monitoring
Vendor contract management
Clinical escalation management
AWARDS AND SCHOLARSHIPS
Honor Society, 2013, Long Island University, STAR Award, Q3 2021, Advanced Clinical/CSL Behring
THERAPEUTIC AREA EXPERIENCE
- Central Nervous System: Major Depressive Disorder, Multiple Sclerosis, and Parkinson's Disease
- Dermatology: Hidradenitis Suppurativa
- Endocrinology: Diabetes
- Hematology: Heparin-induced Thrombocytopenia and Sickle Cell Anemia
- Medical Device: Cardiac Pacemakers and Diagnostic Assays
- Oncology: Breast Cancer, Head and Neck Cancer, Prostate Cancer, and Solid Tumors
- Pain: Osteoarthritis
- Rare Disease: Von Willebrand Disease
- Respiratory: Idiopathic Pulmonary Fibrosis, and Non-cystic Fibrosis Bronchiectasis
Certification
Google Data Analysis
Timeline
Senior Clinical Research Associate
IQVIA Biotech
07.2026 - CurrentRead More
Senior Clinical Research Associate | In-House Clinical Research Associate
CELLARITY
12.2025 - 04.2026Read More
Clinical Site Ambassador | Senior Clinical Research Associate
ADVANCED CLINICAL
07.2021 - 06.2025Read More
Senior Clinical Research Associate
ERGOMED
08.2019 - 07.2021Read More
Clinical Research Associate II| Clinical Research Associate | Clinical Trial Assistant
ICON
03.2013 - 07.2019Read More
Long Island University
Bachelor of Science from Health Science
Read More