Melanie Moore

Skills

ALCOA-C Compliance: Expert in applying ALCOA-C principles to ensure high-quality, accurate, and compliant clinical documentation across all research phases, maintaining integrity and regulatory adherence.
Regulatory Compliance: FDA/IRB Submissions, IND/IDE, ICH-GCP, GMP, HIPAA, SOP Development & Implementation
Clinical Trial Management: Phase I–IV Studies, Protocol Development, Informed Consent, Adverse Event & SAE Reporting, Risk Mitigation
Quality Assurance & Data Integrity: CAPA, QASP Reviews, TMF QC, Audit Readiness, ALCOA-C Standards, Inspection Support
Systems & Technology: eTMF, CTMS (Veeva Vault, OnCore, Florence), EDC (Medidata Rave, REDCap, Inform), IRT/IWRS, Payment Systems Integration
Clinical Supply & IP Management: Labeling, Distribution, Inventory Reconciliation, Randomization & Blinding, Drug Accountability
Cross-Functional Collaboration: Sponsors, CROs, QA Teams, Clinical Operations, Regulatory Affairs, Federal & Academic Partners
Patient & Study Oversight: Subject Safety Monitoring, Confidentiality Protection, Multicultural Patient Engagement, Recruitment & Retention Strategies

About

Clinical Research & Regulatory Affairs Manager with over a decade of experience driving compliance, patient safety, and data integrity across global, academic, and federal research environments. Proven expertise in FDA/IRB submissions, IND/IDE processes, ICH-GCP standards, and GMP compliance, with a strong record of ensuring audit readiness, protocol adherence, and trial integrity across Phase I–IV clinical trials. Skilled in eTMF/CTMS oversight, quality management systems, risk mitigation, and SOP implementation, with hands-on experience in adverse event reporting, informed consent, and study documentation. Adept at cross-functional collaboration with CROs, sponsors, QA, and regulatory agencies, advancing drug, biologic, device, and vaccine research while maintaining the highest standards of regulatory compliance, operational efficiency, and patient-centered outcomes.