Results-driven professional with extensive experience in clinical trial management and regulatory compliance. Skilled in documentation and reporting, staff training, certified rater and cultivating partnerships, aiming to enhance trial efficiency and participant engagement in diverse communities.
Overview
23
23
years of professional experience
Work History
Manager II Trial Execution Services
Global Alzheimer's Platform Foundation
Boca Raton, FL
04.2025 - 07.2026
Lead operational activities supporting multi-site Phase II through Phase IV CNS clinical trials within a national research network.
Executed comprehensive clinical monitoring and backup coverage for Aphelia and Bio-Hermes-002 studies, ensuring adherence to ICH GCP standards.
Cultivated partnerships and organized local outreach and engagement events on the East Coast of South Florida to promote Alzheimer's disease awareness, improve diversity clinical trial participation while supporting trust building among underrepresented communities.
Conducted thorough assessments of research activities to implement quality assurance protocols that maintain regulatory compliance.
Supported monitoring activities by reviewing monitoring reports, identifying quality issues, and escalating risks to study leadership when necessary.
Developed site engagement strategies that reduced screen failure rates by more than 50 percent and improved recruitment performance for low-performing and middle-performing sites across the network
Collaborated with data management teams to review clinical data trends, protocol deviations, and query resolution to ensure database readiness.
Maintained Trial Master File documentation and supported ongoing inspection readiness across participating research sites.
Tracked key study metrics including enrollment performance, regulatory readiness, and data quality indicators across participating sites.
Manager of Recruitment-Clinical Trial Optimization
Global Alzheimer's Platform Foundation
Boca Raton, FL
10.2021 - 04.2025
Lead operational activities supporting multi-site Phase II through Phase IV trials that include Alzheimer’s Disease, Parkinson's Disease, and Neurodegenerative Disorders.
Executed comprehensive clinical monitoring and back-up coverage for the Bio-Hermes-001 study, ensuring adherence to ICH GCP standards.
Facilitated site feasibility and site activation; enrollment performance and management; monitoring oversight and site performance review; data quality review and query resolution; TMF maintenance and inspection readiness.
Facilitated cross-functional team collaboration to drive innovative solutions for caregiver support programs.
Clinical Trial Monitor
USC Keck School of Medicine at the Alzheimer's Therapeutic Research Institute (ATRI)
Boca Raton, FL
04.2016 - 10.2021
Conducted thorough clinical monitoring and provided back-up coverage for EARLY Alzheimer's study, ensuring protocol adherence and participant safety.
Served as a back-up lead in identifying and introducing new monitoring procedures to optimize employee and team performance, overseeing the execution of the Standard Operating Procedures, protocol implementation, site selection and study start-up in order to maintain and standardize Good Clinical Practice in each site.
Independently conducted study site visits that include training and leading site personnel in protocol procedures and compliance, implementation, and administration of neuropsychological assessments.
Conducted auditory review of the Preclinical Alzheimer's Cognitive Composite (PACC) neuropsychological assessments to verify the quality of administration, scoring, resolution of queries, provision of feedback to raters regarding scoring trends, and retraining of the ADAS-COG. This review aimed to ensure that the assessments were administered and scored accurately, addressing any questions that arose, while also offering constructive feedback to the raters on their scoring patterns and facilitating retraining for the ADAS-COG.
Psychometric Clinician
Schmidt College of Medicine at Florida Atlantic University
Boca Raton, FL
02.2015 - 04.2016
Conduct cognitive assessments for Alzheimer's Disease clinical trials.
Ensure protocol adherence and inter-rater reliability across clinical visits.
Collaborate with investigators and study teams to monitor participant progress and maintain accurate data capture on case report forms.
Psychometrician / Clinical Psychometric Rater
Brain Matters Research
Delray Beach, FL
01.2011 - 01.2015
Performed assessments of global clinical status; formulated and documented impressions about disease severity and global change; maintained "blinded rater" status; administered objective tests for memory function, caregiver questionnaires, depression, and other neuropsychiatric disorders.
Serve as, or assist, Study Coordinators in all facets of protocol; interact with patients, families and pharmaceutical sponsors. When assigned, screen, evaluate, and follow patients throughout the course of clinical drug trial; and enter all data in the electronic master file (eTMF).
Communicate with and implement orders from Principal and Sub-Investigator.
Psychometric Clinician /Clinical Research Coordinator
Brain Matters Research
Delray Beach, FL
06.2007 - 04.2008
Developed source documents for both new and ongoing studies.
Managed the dispensing and accounting of study drugs in accordance with the protocol.
Conducted pre-screening and screening of potential participants.
Provided training for new coordinators and psychometric raters.
Kept enrollment logs updated and supplied written records of screening, enrollment, and follow-up activities.
Guided the Principal Investigator on the necessary procedures to ensure compliance with the protocol and study visits.
Medical Home Social Worker & Clinical Research Coo
Children's Diagnostic & Treatment Center
Fort Lauderdale, FL
09.2003 - 06.2007
Developed and implemented individualized care plans for diverse populations and conducted home visits to families who were not compliant with their child's doctor visits.
Led for the NIH Pediatric AIDS Clinical Trials Group (PACTG) 219/219C. The observational study evaluated the long-term health, neurodevelopmental functioning, sexual maturation, and clinical complications (like hypercholesterolemia) of children living with HIV and those exposed to highly active antiretroviral therapy (HAART).
Administered cognitive and behavioral assessments to both patient and caregiver questionnaires.
Facilitated workshops to enhance HIV/AIDS education
The HIV status was disclosed to the teenagers once they reached the appropriate age, as identified by the clinicians, principal investigator, and study team.
Collaborated with multidisciplinary teams to coordinate comprehensive care services and provided crisis intervention and emotional support during critical situations.
Advocated for client needs within social service systems and community organizations.
Education
Master of Arts - Child Development
Tufts Unviversity
Medford, MA
05-2003
Bachelor of Arts - Early Childhood Education With Special Needs
Boston University Wheelock College of Education
Boston
05-1997
Skills
Project management
Project planning
Psychometric certification
Trial management
Staff training
Project execution
Team Leadership
Relationship Building
Timeline
Manager II Trial Execution Services
Global Alzheimer's Platform Foundation
04.2025 - 07.2026
Manager of Recruitment-Clinical Trial Optimization
Global Alzheimer's Platform Foundation
10.2021 - 04.2025
Clinical Trial Monitor
USC Keck School of Medicine at the Alzheimer's Therapeutic Research Institute (ATRI)
04.2016 - 10.2021
Psychometric Clinician
Schmidt College of Medicine at Florida Atlantic University
02.2015 - 04.2016
Psychometrician / Clinical Psychometric Rater
Brain Matters Research
01.2011 - 01.2015
Psychometric Clinician /Clinical Research Coordinator
Brain Matters Research
06.2007 - 04.2008
Medical Home Social Worker & Clinical Research Coo
Children's Diagnostic & Treatment Center
09.2003 - 06.2007
Master of Arts - Child Development
Tufts Unviversity
Bachelor of Arts - Early Childhood Education With Special Needs