Work experience
• Freelance Senior Clinical Research Associate
From Feb 2014 to present
Currently available, mobile throughout France
Mar 2014 – present : cardiovascular medical device, 6 sites in France (start up and monitoring)
• Senior Clinical Research Associate home-based Brest
QUINTILES.
From Apr 2007 to Nov 2013
In a sponsor dedicated team (PFIZER), monitored phase II to IV international studies in oncology, cardiology, pneumology, infectiology, neurology, psychiatry, hematology, endocrinology, ophthalmology, dermatology, nephrology, gastro-enterology
• Clinical Research Associate. SERVIER Laboratories. Paris
From Jan 2000 to Mar 2007
Preparation and follow-up of large multi-centre studies (Phase I to III) in psychiatry, endocrinology, gynecology, rheumatology, cardiology, oncology, angiology. Experience in hospital and at GP sites
Professional skills
• Disease areas: 16 therapeutic areas including medical device
• Preparation of study documents tools and processes (design and validation of CRF, pocket card, diary, monitoring guide, investigator's meeting presentations...)
• Feasibility studies
• Investigational site selection
• Regulatory submissions (CA and EC)
• Negotiation of contracts with investigational sites and institutions
• Study start up and initiation
• All monitoring activities (site contact and management, logistic administrative and financial follow-up, consistency with protocol ICH-GCP and SOP, remote monitoring, authentication of data, handling of queries...)
• Site close out
• Pre-audit and inspection
• Training investigators (meeting preparation/speaker) and mentoring junior CRAs
• CRF medical review and coding
Education and Qualifications
• 1999 Clinical Research Associate specific professional training. Sup Santé. Paris.
• 1999 MSc Biochemistry, option Pharmacology. University of Tours.
Work placement about the development of Chlamydia diagnostic by PCR, in INRA (Nouzilly)
Key achievements
• No critical or major finding at audits
• Managed sites with more than 50 patients
• Simultaneously managed 12 studies with 18 active investigator sites
• CRA lead
• Organizing: respect of all project deadlines (site’s training and certification, queries, intermediate analysis, database lock). Monitoring visit report and follow up letter done in less than 5 days (2 days on average), update of sponsor systems, up-to-date training. Referent of a sponsor’s system for sampling data verification within the clinical operation team (organization of training, hotline…)
• Controlling: respect of monitoring plan with good scheduling of monitoring visits, identification and, management of priorities and urgencies. Management of investigational product : supply and re-supply, accountability, tracking, relabeling
• Good communicator: good sense of communication with medical staff in hospital and private departments. Interface between site and sponsor in an international background. Led several working groups and presented conclusions in meetings
Training & Development
• Apr 2014 : Medical device and ISO 14155 training
• Nov 2013 : Expert ICH-GCP Training (Barnett)
• 2007 to 2013 : EU directive, French GCP, Barnett’s GCP accreditation, Pfizer’s CRA certification, FDA regulations, Quality assurance at the investigator site, Challenges at investigational site, Investigational product awareness, Source data verification in action, Laboratory data in clinical trials, Project financial management, Data management for CRAs, Introduction to MedDRA, Introduction to WHO-DRUG, Signature irregularities and fraud, Anti-Bribery, and many training on different pathologies
Other Skills
• Computer : Good working knowledge. Microsoft office, Microsoft sharepoint and CTMS (Trial Manager – Oriam)
• eCRF : Oracle, EDC (Inform)
• Equipped with advanced technology devices (laptop computer, smartphone, ADSL connection…)
• Languages : native French speaker, professional English, basic knowledge of German
• Driving license (full and clean)
• Mobile throughout France, located in Brest (Brittany), Air France Flight travel saver card
• Interests : Horse riding, swimming
Therapeutic experience in detail
• Oncology : Lung, Breast, Prostate, Kidney, Colon, Pancreas, Head and neck, Metastatic
• Psychiatry : Schizophrenia, Bipolar disorder, Depressive disorder, PTSD (Post-Traumatic Stress Disorder)
• Cardiology : Heart failure, Hypertension, Stroke, Aortic stenosis• Endocrinology : Obesity, Diabetes Mellitus (type 1 and type 2)
• Pneumology COPD (Chronic Obstructive Pulmonary), Asthma, Nicotine dependence
• Gynecology : Menopausal syndrome
• Rheumatology : Osteoporosis
• Infectiology : Viral Hepatitis, Aspergillosis
• Neurology : Epilepsy
• Hematology : Invasive fungal infection
• Ophtalmology : Macular degeneration
• Dermatology : Psoriasis, Malignant melanoma
• Nephrology : Chronic renal failure syndrome
• Gastro-enterology : Crohn’s disease
• Angiology : Venous insufficiency
• Medical device : cardiology and endocrinology
Senior Clinical Research Associate
