Laura Lecuyer
Hersin Coupigny
Profil professionnel
Results-driven Senior Clinical Research professional with 14 years of experience in clinical research, specializing in oncology and multi-therapeutic development programs. Expertise in site management, clinical monitoring, and compliance with ICH-GCP and regulatory standards. Proven ability to mentor junior CRAs, coordinate cross-functional teams, and enhance study quality and site performance. Prepared to transition into a Clinical Lead role, leveraging a solid scientific background and hands-on clinical operations experience.
Vue d'ensemble
3
3
Languages
15
15
years of professional experience
Expérience
Senior Clinical Research Associate
IQVIA
2022.12 - Current
- Independently manage clinical trial sites across start-up, initiation, monitoring, remote monitoring and close-out, in accordance with protocols, ICH-GCP, SOPs and applicable regulations.
- Conduct site management activities across multiple protocols, sites and therapeutic areas, ensuring data quality, patient safety, protocol compliance and overall study performance.
- Perform comprehensive monitoring activities, including source data review/verification, essential document review, investigational product accountability and assessment of site compliance.
- Establish and maintain effective communication with investigators and site teams, proactively identifying operational challenges and implementing appropriate action plans.
- Monitor recruitment, site performance and study progress, escalating risks and quality issues appropriately to the study team.
- Collaborate closely with Clinical Operations and cross-functional study team members to support successful study execution.
- Deliver protocol and study-specific training to investigators and site staff and ensure ongoing understanding of study requirements.
- Mentor and support junior CRAs, sharing monitoring expertise, operational knowledge and best practices.
- Contribute to inspection and audit readiness through proactive review of study documentation, site compliance and outstanding action items.
- Prepare accurate and timely monitoring reports, follow-up letters, action plans and other required study documentation.
Clinical Research Consultant & Founder
LAURA LECUYER
2019.09 - 2022.12
- Independent clinical research consultant supporting sponsors, CROs and investigative sites across clinical research projects, with responsibilities spanning CRA, CTA and Clinical Project Management activities.
- Managed site relationships and acted as a key interface between sponsors, CROs, investigators and local clinical teams.
- Supported clinical projects from feasibility and study start-up through monitoring, project coordination and close-out.
- Conducted site selection, pre-selection activities, Site Initiation Visits, interim monitoring visits and close-out visits.
- Monitored recruitment and patient inclusion activities, identified recruitment risks and implemented corrective actions with investigative sites.
- Ensured study conduct in accordance with protocols, monitoring plans, ICH-GCP, sponsor procedures and applicable regulatory requirements.
- Reviewed study documentation and maintained ISF, TMF/eTMF and CTMS in accordance with applicable procedures.
- Monitored and followed up AE/SAE reporting, ensuring appropriate documentation and escalation in accordance with GCP and SOP requirements.
- Supported sponsor audits, including preparation activities, audit follow-up and CAPA management.
- Participated in protocol feasibility assessments and contributed to the definition of study resources, timelines and operational requirements.
- Reviewed and supported project budgets, resource requirements and client proposals.
- Coordinated and facilitated project teams, investigator meetings and national/international project meetings.
- Identified operational risks and issues and developed appropriate mitigation and action plans.
- Coordinated external partners, including CROs and other clinical research providers, maintained regular communication and project follow-up.
- Developed study documentation and operational materials, including monitoring guides and communication plans.
- Provided training to study teams and contributed to continuous improvement of clinical research processes.
- Acted as the main point of contact for clients, facilitating communication and addressing concerns., ensuring clear communication, alignment of expectations and effective project delivery.
Study Coordinator · Clinical Research Associate · Clinical Trial Assistant
CHU Lille
2012.01 - 2019.01
- Coordinated clinical research projects, ensuring compliance and effective communication across clinical trials, registries, scientific publications, and medical/scientific communications.
- Supported clinical trial activities throughout study set-up, patient follow-up, and study close-out, enhancing overall study flow and participant engagement.
- Collected, entered, reviewed and reported clinical trial data, contributing to data quality and study integrity.
- Developed and maintained monitoring tools, databases and study tracking systems.
- Acted as an effective interface between investigators, clinical teams and sponsors.
- Supported monitoring and quality control activities for clinical research projects sponsored by the institution.
- Contributed to the scientific, technical and regulatory quality oversight of clinical research activities.
- Assessed and planned human, logistical, and financial resources for clinical research projects, ensuring optimal allocation and utilization.
Formation
Clinical Project Manager Certification -
FORMATIS
Vélizy-VillacoublayMaster's Degree - Clinical Research Engineering
Institut Lillois d'Ingénierie de la Santé (ILIS)
LilleBSc - Biology
University of Lille
LilleCompétences
- Clinical Trial Operations
- Site Management
- Study Start-Up
- Site feasibility
- Initiation
- Activation
- Study Close-Out
- Risk-Based Monitoring
- Risk Management
- Protocol Compliance
- Quality Assurance
- Recruitment Oversight
- Safety Oversight
- Clinical Data Review
- CTMS Management
- Document management
- Performance Metrics
- Corrective Action Plans
- Issue Escalation
- Site training
- Stakeholder management
- CRA Mentoring
- Team Support
- Reporting
Language
Français
NATIVE LANGUAGE
English
Working proficiency
Spanish (Castilian)
Débutant
Informations complémentaires
- Endurance sports — Running, swimming, road cycling and hiking
- Music — Flute, drums and trombone
- Reading — Non-fiction, biographies and historical literature
Chronologie
Senior Clinical Research Associate
IQVIA
2022.12 - Current
Clinical Research Consultant & Founder
LAURA LECUYER
2019.09 - 2022.12
Study Coordinator · Clinical Research Associate · Clinical Trial Assistant
CHU Lille
2012.01 - 2019.01
Clinical Project Manager Certification -
FORMATIS
Master's Degree - Clinical Research Engineering
Institut Lillois d'Ingénierie de la Santé (ILIS)
BSc - Biology
University of Lille