Quintiles
- Lead Clinical Research Associate - homebased
Durham2010 - 2016Monitoring of international clinical trials for the major industrial sponsors.
Identification and selection of the most appropriate sites to conduct the study.
Provide a high rate of monitoring visits in a challenging environment - Monitoring a large number of sites in France and West Indies.
Manage interim and final analysis within timelines in order to meet sponsor’s expectations.
Development of patient enrolment strategies with the project team and clinical trial sites.
Coordination of monitoring activities in France and reporting to the study team and sponsor.
Supervision and training of the local CRA team and junior CRAs mentoring.
Development of monitoring and working tools for the CRAs.
Improvement of recruitment methods in collaboration with sponsor.
Involved in the start-up activities, administrative documents collection and follow-up of contract negotiations with sites.
Phases I to IV
Therapeutic areas: Oncology, Neurology, Psychiatry, Cardiology, Hematology, Dermatology, Rheumatology.
Quanta Medical
- Clinical Research Associate
2008 - 2010Monitoring of national and international clinical trials.
Perform selection, initiation, monitoring, boosting and close-out visits.
Management of on-site activities in accordance to the ICH/GCP: source data verification, drug accountability, safety management, review of investigator site file, GCP training for site staff, audit preparation, management and follow up.
Managing a national clinical study in close collaboration with sponsor and CRO director.
Regulatory submissions (France and Belgium) and start-up activities.
Managing study budget and vendors.
Development of study documents: protocol, informed consent, CRF, monitoring guidelines.
Phases III, IV and non-interventional studies
Therapeutic areas: Gynecology, Dermatology, Gastroenterology
CHU de nantes
- Study Coordinator trainee
Nantes2007 - 2007Planning and attending patient visits
CRF completion and queries resolution
