Lisa Carfora

Sr Regulatory Document & Submission Specialist @Worldwide Clinical Trials

West Haven, CT, US
EMAILS
l••••••••@worldwide.com
MOBILE NUMBERS
+12•••••••19

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WORK HISTORY

Feb 2026 — Present

Sr Regulatory Document & Submission Specialist @Worldwide Clinical Trials

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Started with Catalyst Clinical Research in 2016, which was acquired by Worldwide Clinical Trials in 2026.

EDUCATION

2004 — 2009

Albertus Magnus College

Bachelor's Degree, Business, Management, Marketing, and Related Support Services

SKILLS

Medical WritingClinical MonitoringU.s. Food and Drug Administration (Fda)Research and Build Electronic Submission Documents for Assigned ProjectsClinical DevelopmentIch-GcpDrug DiscoveryBiotechnologyMicrosoft OfficeClinical Data ManagementClinical TrialsPharmaceutical IndustrySopFdaCardiologyDiabetesQuality AssuranceManagementOncologyProtocolRegulatory AffairsElectronic Common Technical Document (Ectd)Software DocumentationEdcTherapeutic AreasPharmacologyCtmsLife SciencesValidationRegulatory SubmissionsCROCustomer Service21 Cfr Part 11Regulatory RequirementsIndClinical ResearchClinical PharmacologyDrug DevelopmentGcpBiopharmaceuticals

ABOUT LISA CARFORA

Professional with 19+ years expertise in the coordination of global clinical study documentation: compiling, editing, formatting and submission of technical Regulatory documents such as NDAs, INDs, IBs, DSURs, CSRs, SAPs, IMPDs, Briefing Documents, CMC reports, etc. Coordination of Registration and updating the ClinicalTrials.gov website. QC of Informed Consent forms and TMF. Demonstrated ability to manage multiple projects individually as well as in a team with strong detail, problem solving and follow through skills to achieve results. Participation in Audits. Strong technical skills and attention to detail, with computer proficiency in MS Word, Accenture StartingPoint, Adobe Acrobat, TRS Toolbox, EndNote, eCTD Viewer, Documentum, GlobeDoc, FirstDoc, ShareDoc, Qumas, Medidata Rave, Sharepoint, PleaseReview, Egnyte, Filezilla, Excel, PowerPoint, Publisher, Lotus Notes, Outlook, IMPACT, Business Objects, SAS and many more.

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