Sra. Núria Pérez Picado

Institutions of which it is part

I have a degree in Pharmacy from University of Barcelona and I have a "Master in monitoring International Clinical Trials" and a "Postgraduate Degree in Pharmacovigilance". Since March 2014 I have been part of Academic Research Organization (ARO) of VHIR. Initially as CRA and since 2015 as Project Manager From 2008 to 2013 I worked as CRA and Project Manager at Anagram-ESIC

Curriculum

Over 15 years of experience working in clinical research as a Clinical Research Associate/CTM.

Clinical Research Therapeutic Areas:
- cardiovascular
- neurology
- hematology
- oncology
- allergology
- dermatology
- psychiatry
- digestive
- Otorhinolaryngology
- infectious diseases
- neurosurgery and traumatology
- rheumatology
- endocrinology

Key Activities:
- Clinical Trials and observational studies start-up.
- Supervision and follow up of submissions to Ethics Committees and Competent Authorities; allegations management, amendments and notifications.
- Identifying and resolving issues
- Pre-study, initiation, monitoring and close out visits: Revision of reports
- DSUR and annual follow up reports: writing and revision.
- Design, adaptation and revision of protocol, PIS+ICF, CRF, monitoring plan, data validation plan and laboratory manual.
- Revision of pharmacovigilance and laboratory manual.
- Translation of protocol, PIS+ICF, patient diary and other documents of the trial.
- Preparation of presentations for pre-study and initiation visits.
- Preparation of presentations for investigator’s meetings.
- Newsletters: writing
- Management and control of trial medication and investigational products according Drug Management Plan.
- Creation of labels for study medication.
- Creation of laboratory kits.
- Contract negotiation
- Hiring of vendors: insurance policy, couriers, CRF, laboratory material etc..
Núria Pérez Picado

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