Evelyn Elizabeth Calva Simbaña
Barcelona
Summary
A multitask professional, enrolled in national and international projects, with strength abilities to read and understand multiples corporate cultures from different countries that has allowed me to adapt to complex environment. I am capable to work on global and specific goals, providing support on the restructuration of laboratories, making them grown up and obtaining International Quality Accreditations. I also have excellent communication skills and motivation.
Overview
17
17
years of professional experience
Work History
Clinical Research Quality Manager
Vall d'Hebron Institut of Research
05.2022 - Current
- Participate in the activities of the Clinical Trials Transversal Coordinating Group for continuous improvement
- Write standard operation procedures
- Register, monitor and follow-up findings and improvement opportunities
- Participate in the validations of the Computerised Systems according to GXP
- Analyse Quality Indicators
- Participate in the support of sponsor GCP audits and health authorities-Inspections and make CAPA´s
- Perform internal audits
- Analyse clinical trial process performance
- Detect improvement opportunities of the clinical trial process throughout the institution
- Analyse customer satisfaction and improvement opportunities.
Clinical Trial Study Coordinator - Epilepsy Unit, Neurology Department
Vall d'Hebron Institut of Research
08.2021 - 05.2022
- Coordinate phases II, III and IV development of clinical trials
- Attend conferences and investigator meeting, covering the main areas
- Support monitoring visits, audits
- Get training on Good Clinical Practice and Quality Assessment to assist the investigator in the correct compliance of Good Clinical Practice
- Keep up-to-dated both paper and electronic database, resolving queries, and reporting AEs and SAEs following all procedures required per protocols
- Keep the Investigator Site File up-to-dated
- Coordinate patient management and visit, doing the follow up patient per protocol, avoiding protocols deviations
- Coordinate and assist the CRA, on the monitoring process, providing up-to-date source documents and resolving queries according to time required per protocol.
Clinical Trial Study Coordinator - Epilepsy Unit, Neurology Department
Vall d'Hebron Institut of Research
04.2016 - 12.2016
- Coordinate phases II, III and IV development of clinical trials for naïve and refractory epileptic patients
- Attend conferences and investigator meeting, covering the main areas
- Support monitoring visits, audits and regulatory agencies as the Federal Drug Administration (FDA) inspection
- Get training on Good Clinical Practice and Quality Assessment to assist the investigator in the correct compliance of Good Clinical Practice
- Keep up-to-dated both paper and electronic data base, resolving queries, and reporting AEs and SAEs following all procedures required per protocols
- Keep the Investigator Site File up-to-dated
- Coordinate patient management and visit, doing the follow up patient per protocol, avoiding protocols deviations
- Coordinate and assist the CRA, on the monitoring process, providing up-to-date source documents and resolving queries according to time required per protocol.
Coordinator of Quality of Laboratories of Pathological Anatomy and Clinical Laboratory
Eugenio Espejo Specialties Hospital
11.2014 - 12.2015
- Implementation of the Quality Management and Quality Control of the Laboratories (ISO 9001, 14001, 15189, 19011)
- Performing Internal Audits to Laboratories
- Participation in the Accreditation Canada which obtained the Hospital
- Training for Laboratories staff in Quality Management and Control
- Participation in structural and technological restructuring and implementation of new processes in the laboratories.
Clinical Laboratory Supervisor
Eugenio Espejo Specialties Hospital
01.2012 - 09.2013
- Responsible for a staff of 60 people
- Planning and optimization of the Laboratory processes
- Implementation of the Quality Management system
- Validation of results and patient care
- Active participation in the laboratories restructuring project
Responsible of Molecular Biology Laboratory
Blood Center - Transfusion Medicine- Red Cross
05.2010 - 12.2011
- Responsible for the structuring and implementation project of the Laboratory of Molecular Biology
- Implementation of new technology and analysis to be carried out at the national level
- Responsible for Human resources for Molecular Biology Laboratory
- Processing samples of human and HIV, HCV and HBV analyze
- Collaboration with other Institutions in research.
Scholarships, Specialist and Sales Support - Diagnostic Area
ROCHE - Diagnostic
10.2006 - 07.2009
- Support to Technical Service Manager
- Customer service - call center
- Replacement as Specialist and accompaniment to engineering
- Sales assistant, direct relationship with Sales Management
- Preparation of technical proposals and budgets, request of orders, handling SAP, handling of technical information
- Preparation of reports, organization of meetings
- Replacement Specialist Product of Molecular and participation in public projects, direct relation with the Molecular and Marketing Manager.
Education
Master's degree - Biochemistry, Molecular Biology and Biomedicine
Autonomous University of Barcelona
Barcelona, Spain01.2014
Senior Diploma - Business Management
Escuela Politécnica Del Ejército
Quito, Ecuador01.2011
Biochemistry Pharmaceutical Option Clinical Biochemistry -
Universidad Central del Ecuador
Quito, Ecuador01.2006
Skills
- Certification in Good Clinical Practice (GCP)
- Office & Internet user level
- SPSS & Access
- Several experiences with both paper and e-CRF
- Quality management and quality control
- Quality audits
- Project development
- Problem solving
- Quality assurance
- Internal audits
- Communication
- Regulatory affairs
Languages
English
Upper intermediate (B2)
Portuguese
Intermediate (B1)
Catalan
Intermediate (B1)
Spanish
Bilingual or Proficient (C2)
Timeline
Clinical Research Quality Manager
Vall d'Hebron Institut of Research
05.2022 - Current
Clinical Trial Study Coordinator - Epilepsy Unit, Neurology Department
Vall d'Hebron Institut of Research
08.2021 - 05.2022
Clinical Trial Study Coordinator - Epilepsy Unit, Neurology Department
Vall d'Hebron Institut of Research
04.2016 - 12.2016
Coordinator of Quality of Laboratories of Pathological Anatomy and Clinical Laboratory
Eugenio Espejo Specialties Hospital
11.2014 - 12.2015
Clinical Laboratory Supervisor
Eugenio Espejo Specialties Hospital
01.2012 - 09.2013
Responsible of Molecular Biology Laboratory
Blood Center - Transfusion Medicine- Red Cross
05.2010 - 12.2011
Scholarships, Specialist and Sales Support - Diagnostic Area
ROCHE - Diagnostic
10.2006 - 07.2009
Master's degree - Biochemistry, Molecular Biology and Biomedicine
Autonomous University of Barcelona
Senior Diploma - Business Management
Escuela Politécnica Del Ejército
Biochemistry Pharmaceutical Option Clinical Biochemistry -
Universidad Central del Ecuador
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