Valeria Antonella Aguirre
Clinical Trial Assistant Ii @Everest Clinical Research
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WORK HISTORY
Clinical Trial Assistant Ii @Everest Clinical Research
ON, CA
EDUCATION
Academy of Applied Pharmaceutical Sciences
Post graduated Diploma program in Regulatory Affairs and Quality Assurance
University of Buenos Aires
Master's degree, Biochemistry
Academy of Applied Pharmaceutical Sciences
Post graduate diploma program, Clinical Research, drug safety an pharmacovigilance
SKILLS
ABOUT VALERIA ANTONELLA AGUIRRE
Over 2 years of experience in coordination of clinical research projects • P.G.Dip. in Clinical Research, Drug safety, Pharmacovigilance, Regulatory Affairs and Quality Assurance • Strong understanding of ICH-GCP, GMP, TCPS-2, FDA regulations, Health Canada guidelines and clinical trials terminology • Audited 5 research’s protocols and 50+ CRFs • Wrote 1 Clinical Trial Protocol for a North American Pharmaceutical study • Designed booklet CRFs and ported them to Access database • Working knowledge of the Electronic Data Capture System Medidata Rave • Wrote 3 informed consent forms according to ICH GCP guidelines • Wrote 5 SOPs on Clinical Trials related procedures • knowledgeable in preparation of 1 NDS of Pharmaceutical Drug Products in e-CTD format • Experience in presentations about protocols, drugs, and medical devices • Advance in Word, Excel, PowerPoint, outlook and working knowledge of Access and Open project • Well-developed time management, detail-oriented, and able to multi-task • Good interpersonal and communication skills with a team focus • Fluent in English and Spanish
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