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Isabelle GAULARD

TOULOUSE

En résumé

Isabelle Gaulard has over 15 years’ experience working in Clinical Research and is currently starting with CRA Freelance activity. She joined Quintiles in June 2006 as a Senior Clinical Research Associate for 4 years; in April 2010 she became a Principal Clinical Research Associate and since January 2011 she has been working in her current role as a Clinical Research Specialist. Isabelle has experience in all stages of the clinical lifecycle (Investigator Meetings to study archiving) as well as working on all phases of trials I, II, III, IIIB & IV including pediatric. She has gained substantial experience on clinical delivery and in a large array of pathologies: cardiology (including a mega-trial); oncology (7 trials); infectiology; allergology; transplant; neurology; psychiatry; anti-inflammatory; gastro-enterology and dermatology. Isabelle’s current coordination responsibilities include: identifying quality issues with the implement of appropriate corrective actions, escalating findings; CRA support as protocol specialist; organizing and undertaking CRA training for new on-boarding monitors; audit and inspection management; close collaboration and communication with Project Managers, Data Managers, Medical Advisors, Central Laboratories, third party Vendors, Start-up Services and Sponsors. She applies her vast and diverse clinical knowledge skillfully to her current role in helping and guiding CRAs work optimally on her studies.

Mes compétences :
Oncology
Phase II Clinical Trials
Phase I Clinical Trials
Perform site selection
Kidney transplant
Clinical monitoring
Clinical Research
Cardiology

Entreprises

  • Freelance - Freelance Clinical Research

    2017 - maintenant Looking for mission of CRA, SSC or study coordination as Freelance.

  • Quintiles - Clinical Research Specialist

    Durham 2006 - 2017 Last mission: Pole Selection of Site Management from Jun2016 to Feb 2017 with more than 30 SSV visits in 12 different protocols (in addition to the current monitoring visits on phase 1 studies in Oncology).
    Last mission: Clinical Research Specialist – Jan 2010 to Jun 2016.
    Monitoring in France and UK: selection, initiation, monitoring for 50% and Coordination activity for 50%
    • Guide and direct the work of CRAs on site, providing mentoring to ensure quality deliverables of assigned CRAs. • Ensure that clinical monitoring tasks are conducted in accordance with protocol, process, quality standards and expectations, per Contract. • Conduct site monitoring visits for a variety of protocols, sites and therapeutic areas as needed. • Provide input, updates to the Clinical Project Manager regarding the monitoring status and CRA team progress and deliverables. • Act as subject matter expert for operational conduct of the assigned protocol(s) at site • Ensure that new project CRAs are brought on board and receive relevant study information. • Provide input to line managers on their project team members performance relative to study tasks. • Conduct co-monitoring visits to manage data backlog, site compliance and quality issues • Act as site visit report reviewer for assigned studies

  • therapharm - CRA

    2002 - 2004 Monitoring of Phase II/III international studies in renal transplantation, leukemia with bone-marrow grafts, disease of Alzheimer, renal colic.

  • Parexel - CRA

    Paris 1998 - 1998 Monitoring of Phase II/III international studies in renal transplantation, leukemia with bone-marrow grafts, disease of Alzheimer, renal colic.

  • GECEM - ARC

    Rennes 1995 - 1997 Monitoring of Phase III / IV local studies in Oncology (metastasis colorectal cancer), Infectiology (otitis of children, pneumopathy).

Formations

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