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 Associate Anderlecht, 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
Clinical Trial Assistant (CTA)
August 2011 --- March 2016
- TMF subject matter expert and single point of contact for the project manager and clinical study team. Proactively ensures complete and accurate trial master file and documentation quality across clinical trials. Partner with unit team members to resolve document discrepancies, present analysis reporting and provide guidance to each assigned team to drive performance against metric targets according to Good Clinical Practice and relevant standard operating procedures. - Maintenance and coordination of site contact and study information on appropriate tool - Complies and verifies required unit study documentation in order to ensure successful study start-up and evolution following the standard operating procedures. - Support point of contact for principal investigator, project manager and clinical department in the unit.
Clinical Study Specialist; Healthcare Compliance Associate – junior
July 2009 --- December 2010
- Manage site/contact/study information on appropriate tool (Software: CTMS & CDC) - Creates, complies and verifies required regulatory, legal and financial documentation in order to ensure successful study start-up (e.g. site initiation visits, product shipment, start of patient enrolment) following company work instructions. - Create, modify and review study financial agreements (Company template)
June 2008 --- June 2009
- Customer service - Call customer support - Key account, back up key account for special customers - Filing of papers and documents - Point of contact between customers and drivers - Maintenance and coordination of shipping, scheduling pick up and tracking information on appropriate tool.
AssertivenessAdaptabilityAttention to detailAuthenticityCollaborationCompetitivenessCommunicativeCreative thinkingCuriosityDependabilityEfficiencyIndependenceKindnessInterest in knowledgeOrganizationProactivityOptimism
in from Koninklijke Atheneum van Etterbeek in 2008