Mes compétences :
Recherche clinique
Biologie cellulaire
Neurosciences
Entreprises
Syneos Health
- Site Start-Up & Regulatory Specialist
2017 - maintenant- Performs assigned activities within the country that lead to start-up of investigative sites in all phases of clinical trials.
- Responsible for providing delivery and expertise in one or more of the following functional areas: investigator site contracts, ethics and regulatory submissions, and review and finalization of essential documents required for site initiation.
- Ensures local activities are undertaken in accordance with agreed timelines, allocated budgets, and required quality standards.
- Ensures an efficient start-up process on assigned studies.
- May act as main contact with Regulatory Authorities (RA) and Central/Regional Ethics Committees (ECs).
- Under the direction of the Project Manager (PM) or Site Start-up Lead (SSUL) as appropriate, may directly interact with Customers regarding requirements from RA or other local regulatory party.
- Accountable to the PM/SSUL at the project level and line manager for deliverables.
INC Research
- Clinical Research Associate
2017 - 20176-months internship on various international phase I / III studies including the following therapeutic areas: endocrinology, infectious disease, dermatology and oncology.
I am involved in diverse aspects of clinical monitoring including start-up, sites selection, and monitoring activities in accordance with the protocols, SOP, ICH-GCP and applicable regulatory requirements under senior CRAs responsibility, including:
Study protocols review and therapeutic trainings
Co-monitoring visits with experienced CRA : PSSV (tour facility, essential documents collection, verify if the site is suitable for the trial, have all equipment needed according to the protocol, adequate staff, relevant population for the study), IMV (ICF and SAEs review, source data verification, queries resolution, eCRF correction, drug and study material accountability, verification of IP dispensing and IP reconciliation under senior CRA responsibility)
Review of annotated reports, confirmation and follow-up letters, study slides, monitoring plans
Working closely with CRAs to facilitate the smooth running of their trials from the start-up phase
Trial Master File maintenance and submission, essential documents customization and collection
Fluent communication with site team (PI, SI, SC) and follow-up for French and Belgian sites
Daily and weekly reporting and tracking with CRA and lead-CRA during international teleconferences
Feasibility for several studies: identifying suitable investigators, distributing and collecting Potential Investigator Questionnaires and Confidential Disclosure Agreement
IGH - CNRS
- PostDoc
2011 - 2016
University of Cambridge
- PostDoc
2008 - 2011
CHU de Rouen
- Ingénieur de Recherche
Rouen2007 - 2008
INSERM U614
- Doctorant
2001 - 2007RESEARCH EXPERIENCE
Sept 02 – March 07
INSERM U614, (Pr T. Frébourg), University of Rouen, France.
Research theme : Analysis of the mechanisms of toxicity of human protein tau in Drosophila melanogaster.
Sept 01 – Sept 02
INSERM EMI 9906, (Pr T. Frébourg), University of Rouen, France.
Research theme : Development and phenotypic analysis of transgenic flies expressing human amyloïd beta-peptide.
