Available to hire
I am a resourceful, solution-driven professional with 10+ years of regulatory and quality assurance experience in clinical research settings. I excel at turning challenges into streamlined, compliant processes and delivering timely, data-driven results.
A personable team player, I empower staff, set clear expectations, and drive cross-functional collaboration. I am open to new opportunities in federal government, pharmaceutical, academia, or related fields and am willing to telecommute 100%.
Experience Level
Expert
Expert
Expert
Expert
Intermediate
Intermediate
Language
Work Experience
Research Regulatory Associate – Department of Pediatrics, MSK Kids at Memorial Sloan Kettering Cancer Center
January 1, 2019 - November 14, 2025Provide regulatory management of research protocols within the Pediatrics Department, Neuroblastoma service; ensure that all appropriate Institutional, State, and Federal regulations are followed throughout the conduct of the clinical research trial; manage all protocol regulatory activities required for study activation; develop new protocol submissions, including protocol document, appendices, and informed consent; maintain comprehensive GMP/GLP? TMF; prepare and submit single-patient use protocols to IRB, external sponsor, and federal agencies; design protocol tools; support IND applications; prepare amendments and continuing reviews; report deviations, data safety reports, SAEs; respond to monitoring findings and develop CAPAs; coordinate with sponsors for timely submissions.
Regulatory & Quality Manager – Clinical Operations at Memorial Sloan Kettering Cancer Center
December 31, 2018 - December 31, 2018Provided direct oversight and management of clinical trial regulatory document collection, review, and maintenance across the PCCTC portfolio; reviewed QA workflows and policies; implemented changes to improve day-to-day operations; oversaw TMF maintenance and progressed eTMF modernization for real-time audit readiness; identified system needs and ensured design alignment; created/updated policies; supervised and evaluated CRAs; ensured regulatory requirements dissemination; implemented solutions to streamline monitoring and accelerate trial enrollment and data quality.
Senior Clinical Research Monitor – Clinical Research Administration, QA at Memorial Sloan Kettering Cancer Center
December 31, 2017 - December 31, 2017Managed day-to-day operations of the clinical research monitoring program for investigator-initiated trials; led training and performance management; analyzed trends and implemented changes to improve monitoring efficiency; ensured program consistency across Clinical Research Monitoring and Multi-Site Compliance; supervised monitors; ensured monitoring visit findings were addressed; supported CAPA development; prepared for FDA/EMA inspections and conducted internal audits as needed.
Clinical Research Quality Assurance Specialist (promotion) at Memorial Sloan Kettering Cancer Center
December 31, 2012 - December 31, 2012QA oversight for the clinical research monitoring program; coordinated audit preparation; reviewed Phase I–III trial data for relevant committees; recorded audit data and findings; conducted ongoing monitoring reviews for MSK clinical trials.
QA Research Study Specialist (promotion) at Memorial Sloan Kettering Cancer Center
December 31, 2012 - December 31, 2012QA and regulatory oversight; prepared for audits; monitored patient cases and regulatory binders; maintained audit database; conducted ongoing monitoring reviews for MSK trials.
Pharmacokinetics Specialist – RSA II at Memorial Sloan Kettering Cancer Center
December 31, 2011 - December 31, 2011Pharmacokinetic analyses and related support for trials.
Pharmacokinetics Specialist – RSA I at Memorial Sloan Kettering Cancer Center
December 31, 2010 - December 31, 2010Pharmacokinetic analyses and related support for trials.
Research Associate – High Throughput Behavioral Testing System at Psychogenics, Inc.
December 31, 2009 - December 31, 2009Worked on high-throughput behavioral testing system research; supported clinical research activities.
Clinical Research Assistant – Schizophrenia Research at Massachusetts General Hospital
December 31, 2007 - December 31, 2007Assisted in clinical research on schizophrenia; data collection and management.
Education
Masters of Arts in Music Education at Manhattanville College/University
September 20, 2000 - May 20, 2000MS Regulatory Affairs for Drugs, Biologics and Medical Devices at Northeastern University
January 11, 2030 - November 14, 2025BS Behavioral Neuroscience at Northeastern University
January 11, 2030 - November 14, 2025Qualifications
Human Subjects Protection Certificate
January 11, 2030 - November 14, 2025Good Clinical Practice Certificate
January 11, 2030 - November 14, 2025Human Subjects Protection Certificate
January 11, 2030 - November 14, 2025Good Clinical Practice Certificate
January 11, 2030 - November 14, 2025Industry Experience
Media & Entertainment, Education, Other, Healthcare, Life Sciences, Professional Services
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