Dedicated Clinical Research Regulatory Associate with more than seven years’ experience who can provide comprehensive support for clinical research projects. Experienced with maintaining trial tracking systems. Organized, detail-oriented, and conscientious quality oriented, able to strategize and prioritize effectively to accomplish multiple tasks and stay calm under pressure.
Clinical Research Regulatory AssociateAnderlecht, Belgium
Since April 2016
Responsible for day-to-day management and maintenance of all the local and global systems, tracking tools and study related databases.
Proficient in interdepartmental coordination and communication for ensuring clinical trials documents are completed in accordance with scientific, medical, and ethical principles, within regulatory requirements/guidelines and Pfizer SOPs.
Responsible within the Regulatory team to ensure that studies are conducted scientifically and ethically and in compliance with EMEA/FDA/ICH/GCP guidance and regulation.
Lead and overview the administrative work related to completion of trials (communications to EC and/or CA)
Provide support in the preparation, quality verification of the clinical documents submitted to the competent authorities and ethics committees
Responsible for the maintenance and archiving of study files
AssertivenessAdaptabilityAttention to detailAuthenticityCollaborationCompetitivenessCommunicativeCreative thinkingCuriosityDependabilityEfficiencyIndependenceKindnessInterest in knowledgeOrganizationProactivityOptimism
in from Koninklijke Atheneum van Etterbeek in 2008