Susan Cicatelli
Rockville
Summary
Accomplished Senior Clinical Research Associate with two decades of experience in phase I-IV trials, specializing in vaccines, infectious diseases, and monoclonal antibody studies. Skilled in protocol development, site management, SAE reporting, and trial close-out procedures. Proficient in utilizing EDC/CTMS systems, conducting NIH assessments, and recruiting volunteers for clinical trials.
Overview
15
15
years of professional experience
Work History
Senior Clinical Research Associate
PPD, Thermo Fisher Scientific
06.2021 - Current
- Lead CRA for six Phase Ib–II monoclonal antibody trials in Transplant, Genitourinary, and Hematology/Oncology.
- Conduct site visits, SDV/SDR, and AE/SAE monitoring; liaise with DAIT Project Managers.
Clinical Research Associate / Clinical Trial Manager / Project Manager
ICON Government & Public Health Solutions
05.2019 - 06.2021
- Managed Phase I trials including Marburg/Ebola vaccine and COVID-19 specimen collection.
- Oversaw site compliance, monitoring, protocol development, training, and remote monitoring.
- Coordinated study timelines, sponsor communications, and TMF maintenance.
Clinical Trials Manager
Clinical RM / ICON GPHS
08.2017 - 05.2019
- Supervised Clinical RM staff at WRAIR DCT; managed onboarding, SOP development, and volunteer payment systems.
- Liaised with sponsors, managed contracts, and financial forecasting.
Clinical Research Coordinator
Clinical RM, WRAIR DCT
11.2011 - 08.2017
- Coordinated malaria vaccine trials with Controlled Human Malaria Infection; ensured regulatory compliance.
- Managed IRB submissions, investigational product accountability, volunteer recruitment, and staff training.
Human Research Protection Scientist
Clinical RM, WRAIR IRB
08.2010 - 11.2011
- Served as IRB POC; managed continuing reviews, SAE reporting, compliance, and site monitoring.
Education
Adult Nurse Practitioner Certificate, Post-Masters -
George Washington University
Master of Science - Perinatal Nursing
University of Pennsylvania
Bachelor of Science - Nursing
University of Virginia
Certificate - Epidemiology
London School of Hygiene & Tropical Medicine (online)
Skills
- Phase I–IV clinical trial coordination
- Protocol review expertise
- Site monitoring expertise
- SAE/AE compliance reporting
- Product accountability management
- Electronic data capture and clinical trial management systems
- Quality assurance processes
- SOP documentation expertise
- Staff development and leadership
Timeline
Senior Clinical Research Associate
PPD, Thermo Fisher Scientific
06.2021 - Current
Clinical Research Associate / Clinical Trial Manager / Project Manager
ICON Government & Public Health Solutions
05.2019 - 06.2021
Clinical Trials Manager
Clinical RM / ICON GPHS
08.2017 - 05.2019
Clinical Research Coordinator
Clinical RM, WRAIR DCT
11.2011 - 08.2017
Human Research Protection Scientist
Clinical RM, WRAIR IRB
08.2010 - 11.2011
Master of Science - Perinatal Nursing
University of Pennsylvania
Bachelor of Science - Nursing
University of Virginia
Certificate - Epidemiology
London School of Hygiene & Tropical Medicine (online)
Adult Nurse Practitioner Certificate, Post-Masters -
George Washington University
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