Abby Fiocco
Glastonbury,CT
Summary
Clinical research professional with extensive hands on experience in Phase I-III clinical trials, specializing in oncology, neurodegenerative disorders, radiopharmaceuticals, ophthalmology, pulmonology, rheumatology, and rare diseases. Deep understanding of FDA regulations, ICH GCP guidelines, and risk management. Proven ability to enhance efficiency and stakeholder satisfaction through meticulous project management, including financial oversight. Skilled in collaborating with cross-functional teams to deliver high-quality outcomes, while maintaining strong site relationships and optimizing operational study processes.
Overview
14
14
years of professional experience
Work History
Project Manager I
Invicro
02.2021 - 08.2024
- Successfully coordinated global study planning and execution, ensuring timely completion and quality results
- Led cross-functional teams in clinical trial development, fostering strong partnerships with sponsors and research partners to drive successful study outcomes
- Developed solid relationships with stakeholders through regular communication updates, fostering trust and confidence in the team's ability to deliver results.
- Spearheaded development and revisions of study specific manuals, protocols, Data Management Plans, Safety Management Plans, Communication Plans, Clinical Study Reports, site training, and presentations
- Developed and implemented Project Management Plans, incorporating risk mitigation strategies to proactively address potential challenges
- Meticulously managed all assigned project financials, ensuring accurate revenue forecasting and fiscal responsibility
- Built strong site relationships, optimizing setup, training, and approval processes
- Proactively organized and led internal/external kick-off meetings (KOM), operational meetings, and supported data analysis meetings
Clinical Research Manager
Invicro
04.2019 - 02.2021
- Coordinated with research partners, provided clinic representation during sponsor calls, strengthened customer satisfaction, spearheaded recruitment
- Improved clinic operations through new policy development and procedural updates
- Reduced protocol deviations by providing comprehensive training and support to research staff
- Mentored and trained junior staff, cultivated a positive work environment by enhancing clinic efficiency and team proficiency in cognitive assessments
- Contributed clinical expertise to protocol development, database construction, UAT, CRF development, CRF Completion Guidelines, and source document creation to ensure robust clinical trial frameworks were in place
- Developed and led Site Initiation presentations with cross-functional teams
Sr. Clinical Research Coordinator II
Institute for Neurodegenerative Disorders / Invicro
09.2018 - 04.2019
- Executed oversight of clinic operations, staff functionalities, and internal processes
- Initiated collaboration with inter-departmental teams to facilitate successful outcomes
- Developed policies and procedures in support of clinic operations
- Fostered positive relationships by training, guiding, and mentoring clinic staff
- Increased patient retention rates by establishing strong relationships with participants through effective communication and follow-up
- Facilitated clinical trial progression, effectively managing multiple projects simultaneously
- Certified lead cognitive testing rater for approximately 6 neurodegenerative research protocols
Sr. Clinical Research Coordinator
Institute for Neurodegenerative Disorders / Invicro
09.2017 - 09.2018
- Led clinical trial operations, ensuring protocol adherence and patient care excellence
- Provided training, set expectations, monitored performance and directed workflow of direct reports
- Streamlined study visit activities, enhancing operational efficiency while maintaining good clinical practice standards
- Meticulously oversaw day-to-day clinical trial activities, ensuring data integrity and patient safety
- Adapted workflows to meet evolving study requirements
Study Coordinator
Institute for Neurodegenerative Disorders / Invicro
05.2010 - 09.2017
- Proactively supervised Parkinson's and Alzheimer's trials, ensuring compliance with GCP, SOPs, regulations, ensuring timely study processes and data accuracy
- Developed and implemented new source documents and tracking logs, optimizing data collection processes for imaging studies
- Organized and managed clinical monitoring visits
- Administered various neuropsychological tests (e.g., ADAS-Cog, MoCA, MMSE, CDR, etc.) to subjects as a certified rater.
- Coordinated and executed study activities, including medical procedures, biomarker collection and processing, ECG, medical history, AE reporting, and data management
- Streamlined study recruitment, visit tracking, and projections, significantly enhancing operational efficiency and participant retention rates
Education
Pre-Nursing 2018-2019
Gateway Community College
New Haven, CT01-2019
Communicative Sciences And Disorders
New York University
New York, NYSpeech Pathology & Audiology
SUNY At Buffalo
Amherst, NYSkills
- Project Management
- CTMS Implementation Experience
- Protocol Development
- Interpersonal Communication Skills
- Electronic Data Management
- Trial Master File Management
- Risk Mitigation Strategies
- Contract and Budget Management
- Radiopharmaceutical Expertise
- PET/SPECT Imaging Management
- Collaborative Team Management
- Quality Assurance
- Informed consent process
- Pharmacovigilance
Timeline
Project Manager I
Invicro
02.2021 - 08.2024
Clinical Research Manager
Invicro
04.2019 - 02.2021
Sr. Clinical Research Coordinator II
Institute for Neurodegenerative Disorders / Invicro
09.2018 - 04.2019
Sr. Clinical Research Coordinator
Institute for Neurodegenerative Disorders / Invicro
09.2017 - 09.2018
Study Coordinator
Institute for Neurodegenerative Disorders / Invicro
05.2010 - 09.2017
Pre-Nursing 2018-2019
Gateway Community College
Communicative Sciences And Disorders
New York University
Speech Pathology & Audiology
SUNY At Buffalo
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