Helena Pera Pujadas
Senior Clinical Research Associate at Fundació Lluita contra la Sida- Claim this Profile
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Bio
Experience
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Fundació Lluita contra la Sida
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Spain
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Research Services
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1 - 100 Employee
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Senior Clinical Research Associate
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Jul 2018 - Present
-Study start-up (document and manuals preparation, and regulatory procedures). -Monitoring clinical trials, in accordance with approved protocols, standard operating procedures (SOP), and good clinical practice guidelines (GCP). - Selection and start-up, monitoring and close-up visits. - Creation and maintenance of the Study Files. - Management of SAE's, queries, and protocol deviations. - Management of medication and samples. Pharmacy visits. - Trial Management in coordination with the Project Manager of the study. Show less
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CRA and Project Manager
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Nov 2009 - Jul 2018
-Study start-up (document and manuals preparation, and regulatory procedures).Creation and maintenance of the Study Files- Management, coordination and monitoring clinical trials , in accordance with approved protocols, standard operating procedures (SOP), and good clinical practice guidelines (GCP).
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Secretaria técnica del CEIC
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Mar 2010 - Oct 2010
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Hospital Universitari de Bellvitge
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Spain
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Hospitals and Health Care
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700 & Above Employee
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Study Coordinator
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May 2009 - Oct 2009
Study Coordinator and CRA Study Coordinator and CRA
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Education
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Fundación ESAME. Pharmaceutical Business School.
Master en Monitorización de ensayos clínicos, Monitorización de ensayos clínicos -
Universitat de Barcelona
Licenciatura, Farmacia