Laura Lyon

About Laura Lyon

As a Clinical Research Associate at Merck, I leverage my extensive experience in clinical…

Experience

1. Clinical Research Associate

   Merck

   Jan 2023 — Present

   As an Associate CRA at Merck, I leverage my extensive experience in clinical research to ensure the highest standards of clinical trial quality and integrity. As the primary contact between Sponsor and site, I have developed strong site relationships ensuring the continuity of site relationships through all phases of the trial. Performing clinical study site management and monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. With an in-depth understanding of the study protocol and related procedures, I am able to coordinate and manage various tasks in collaboration with other Sponsor roles to achieve Site Ready. Ability to conduct validation, initiation, interim monitoring as well as close out visits by performing both on-site monitoring visits and remote visits providing oversight using various tools to ensure that data generated at the site is complete, accurate and unbiased as well as ensuring all subjects rights, safety and well-being are being protected. Monitors & records clear, comprehensive and accurate visit & non-visit contact details. Collecting and reviewing all required regulatory documentation for study start up, maintenance and close out visits. Communicating with PIs & site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. During performance/metrics discussion, quality or compliance issues are identified; resolved by retraining or by escalation via CRA Escalation Pathway to CRM, Manager, CRD or TA Head. Working together with GCTO, Finance, Regulatory Affairs, Pharmacovigilance, legal & regional operations, HQ functional areas, and with external vendors, IRB/IECs & Regulatory Authorities in support of sites. Manages, maintains and documents information through documentation in CTMS, eTMF, EDC & various systems as appropriate.

Skills

• Information Technology
• Patient Outcomes
• Clinical Trial Analysis
• Quality Patient Care
• Drawing Blood
• Certified Ekg Technician
• Direct Patient Care
• Study Coordination
• Recruiting
• Clinical Psychology
• Case Report Forms
• Drug Accountability
• Appointment Scheduling
• Inform
• Oracle Applications
• Ob/Gyn
• Informed Consent
• Medidata
• Clinical Development
• Data Entry
• Oracle Database
• Regulatory Compliance
• Customer Service
• Study Reports
• Laboratory Equipment
• Clinical Trials
• Laboratory Skills
• Internet Recruiting
• Clinical Research
• Trial Management
• Gynecology
• Clinical Study Design
• Recruitment Advertising
• Healthcare Information Technology
• Drug Safety
• Vital Signs
• Clinical Data Management
• Patient Safety
• Patient Education
• Clinical Pharmacology