Experience

INCLIVA Instituto de Investigación Sanitaria

• Spain
• Research Services
• 100 - 200 Employee

• Clinical Trial Manager

  • Jun 2021 - Present

  Tasks:• Clinical trial start-up activities (pre-initiation).• Give support to trial Sponsors and to Coordinating Principal Investigators.• Responsible for the collection and maintenance of the current Regulatory/Competent Authority (CA) and Ethics Committee (EC) submission information.• Clinical trial planning.• Direct point of contact with assigned sites during start-up phase.• Elaborate, customize and/or review applicable study documents and related forms/logs (Protocols, ICFs...).• Review and negotiate site regulatory documents and contracts with sites for agreement on wording and budgets.• Facilitate and support allocated sites with access to relevant study systems.• Application of Good Clinical Practice principles and regulations applying to clinical trials.• Attend site initiation visits and investigator meetings.• Ensure trial documents and trial master files are permanently updated and properly stored.• Update appropriate Clinical Trial Management Systems (CTMS).• Regulatory notifications.• Coordinate and train study assigned CRAs.• Review monitoring reports.• Control, shipment and reception of samples, drugs, study materials, etc.• Problem (issues, questions and concerns) solving.



Research Foundation of the Valencian Institute of Oncology (IVO)

• Study Coordinator

  • Sep 2013 - May 2021

  Tasks:• Coordination of clinical site activities to achieve a correct performance of any clinical trial procedure according to study protocol.• Problem solving and liaison between the different clinical site departments and involved study staff (investigators, nurses, data managers and others).• In-depth understading of applicable study documents and related forms/logs.• Giving support to investigators to recruit the adequate patients for the clinical trials.• Application of Good Clinical Practice principles and regulations applying to clinical trials.• Identification/Notification of Serious Adverse Events.• Attending monitoring visits with CRAs, investigator meetings, medical conferences and interdisciplinary committees.• Writing SOPs and monitoring compliance within the clinical site.• Ensuring trial documents and investigator site files are permanently updated and properly stored.• Giving support to all the members of investigator team with Case Report Forms (data collection and entry, resolution of queries and discrepancies, password recovery, trainings...).• Control, shipment and reception of samples, drugs, study materials, etc.



Research Foundation of the Valencian Institute of Oncology (IVO)

• Study Coordinator

  • Jan 2013 - May 2013

  Tasks:• Coordination of clinical site activities to achieve a correct performance of any clinical trial procedure according to study protocol.• Problem solving and liaison between the different clinical site departments and involved study staff (investigators, nurses, data managers and others).• In-depth understading of applicable study documents and related forms/logs.• Giving support to investigators to recruit the adequate patients for the clinical trials.• Application of Good Clinical Practice principles and regulations applying to clinical trials.• Identification/Notification of Serious Adverse Events.• Attending monitoring visits with CRAs, investigator meetings, medical conferences and interdisciplinary committees.• Writing SOPs and monitoring compliance within the clinical site.• Ensuring trial documents and investigator site files are permanently updated and properly stored.• Giving support to all the members of investigator team with Case Report Forms (data collection and entry, resolution of queries and discrepancies, password recovery, trainings...).• Control, shipment and reception of samples, drugs, study materials, etc.



Centre for Public Health Research - Vaccine Research Department (CSISP)

• Study Coordinator

  • Dec 2010 - Dec 2012

  Tasks:• Coordination of clinical site activities to achieve a correct performance of any clinical trial procedure according to study protocol.• Problem solving and liaison between the different clinical site departments and involved study staff (investigators, nurses, data managers and others).• In-depth understading of applicable study documents and related forms/logs.• Giving support to investigators to recruit the adequate patients for the clinical trials.• Application of Good Clinical Practice principles and regulations applying to clinical trials.• Identification/Notification of Serious Adverse Events.• Attending monitoring visits with CRAs, investigator meetings, medical conferences and interdisciplinary committees.• Writing SOPs and monitoring compliance within the clinical site.• Ensuring trial documents and investigator site files are permanently updated and properly stored.• Giving support to all the members of investigator team with Case Report Forms (data collection and entry, resolution of queries and discrepancies, password recovery, trainings...).• Control, shipment and reception of samples, drugs, study materials, etc.



Several External Prevention Services (Servicios de Prevención Ajenos - S.P.A.)

• Occupational Health and Safety Technician

  • Jun 2006 - May 2011