Paule-Myriam Alphonse

Happy, fun, reliable, hard work, adoptable, flexible, loving, giving, fair

• Senior Associate Scientist with over 13 years of extensive experience as a Histologist collaborating closely with Pathologists, Translational Research Leaders, and Clinical Trial Teams to manage tissue samples and produce clinical/non-clinical data 
• Experience with trimming, fixation, processing, embedding, microtomy, and special stains
• Experience in IHC Assay Development, AutoStainer, IHC equipment, CAP Inspections, Dermatology Specimen Grossing, and Specimen Accession
• Expertise in operating and maintaining automated stain scanners DAKO PT, Link 48, Bond RX, Ventana Benchmark XT
• Knowledge of FDA, IHC-IF, IRB/EC, and GCLP guidelines for the proper handling of pathology specimens
• Clinical Trial Protocols development, review, and implementation of clinical study protocols to ensure compliance with regulatory and ethical standards.
• Clinical Trials experience supporting all phases of clinical trials, from initiation through closeout, ensuring adherence to GCP and SOPs.
• Clinical Operations coordination and execution of operational activities, including site management, monitoring, and data collection.
• Clinical Trial Management Systems (CTMS) skilled in using CTMS platforms to track study progress, monitor timelines, manage site performance, and maintain documentation accuracy.
• Informed Consent Process knowledgeable in obtaining, reviewing, and documenting informed consent in compliance with ICH-GCP and IRB requirements.
• Institutional Review Board (IRB) experienced in preparing and submitting IRB applications, amendments, and continuing reviews to ensure ethical compliance.
• Trial Management proficient in planning, organizing, and overseeing clinical trials to ensure protocol adherence, subject safety, and data integrity.
• Clinical experience supporting Phase 1-3 Oncology studies to ensure trial data is generated to align with clinical trial timelines 
• Strong analytical skills to evaluate data and qualitative insights to optimize processes, and ensure compliance to regulations

1. Certifications: HTL(Histotechnologist) ASCP, 2015

• Halo Imagescope (Aperio)
• GraphPad Prism
• Electronic Notebook (ELN)
• MS Word, Excel, and Power Point

Drexel University College of Medicine Philadelphia, PA

Master of Science in Histotechnology 2011

Florida A & M University Tallahassee, FL

Bachelor of Science in Molecular & Cellular Biology 2008