Xavier Rodriguez, M Sc
Sr Clinical Site Manager @ Parexel
About
Experienced CRA with more than 16 years in clinical trials management, including implementation of study protocols with special emphasis on compliance with FDA and Health Canada regulations, and on-site data management and collection. Therapeutic areas of experience include dermatology, neurology, rheumatology, oncology, cardiology, endocrinology, allergy/immunology, and infectious diseases. Involved in Phase II, III and III b trials. Involved in one of the most long-term and successful trials conducted by PAREXEL.
Canada
Laval
Pharmaceuticals
Clinical Monitoring, Clinical Research, ICH-GCP, Clinical Trials, Pharmaceutical Industry, Neurology, Rheumatology, Osteoporosis, Oncology, CTMS, GCP, Clinical Research Associates, Drug Development, EDC, Therapeutic Areas, Regulatory Submissions, CRO, Sop, Communication Skills, Problem Solving
Experience
Sr Clinical Site Manager
Parexel
Senior Clinical Research Associate
Parexel
Montreal, Canada Area
• Conduct the clinical monitoring aspect of designated projects • Perform clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, data collection) • Collect regulatory documentation • Perform qualification, initiation, monitoring and termination of investigational sites. • Participate in external client meetings and presentations such as investigator meetings. • Mentoring and training of CRA team members. • Build relationships with investigators and site staff.
Clinical Research Associate II
Parexel
Montreal, Canada Area
• Responsibilities included site management and monitoring for a Phase III Osteoporosis trial in the US and Canada. • Site management and monitoring for a global Phase III neurology study in the US and Canada. Performed Initiation, Interim Monitoring and Close-out visits. • Responsible for query generation and resolution.
CRC
CHUM Hotel-Dieu de Montreal
Clinical Specialist
Baylis Medical
Interventional cardiology devices and monitoring systems
Education
Université de Montréal
Biomedical Sciences
Université de Montréal
Microbiology and Immunology
Xavier Rodriguez, M Sc's Contact Information
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