Farah ZRIBI
Senior CRA at Eshmoun Clinical Research- Claim this Profile
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Bio
Credentials
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HOW TO CONDUCT GCP INSPECTIONS/AUDITS AT THE CLINICAL INVESTIGATOR SITE
The Global Health NetworkJan, 2022- Nov, 2024 -
GCP
Boehringer IngelheimJul, 2021- Nov, 2024 -
Rave EDC
Medidata SolutionsJul, 2021- Nov, 2024 -
Auditeur interne d'un système de management qualité ISO 9001:2015
Dreams N MotionDec, 2020- Nov, 2024 -
MySites : Site monitoring & site management using my sites
impact.comAug, 2019- Nov, 2024 -
ICH GCP E6 (R2)
The Global Health NetworkJul, 2019- Nov, 2024 -
Introduction to data management for clinical research studies
The Global Health NetworkMay, 2019- Nov, 2024 -
Introduction to collecting and reporting adverse events in clinical research
The Global Health NetworkApr, 2017- Nov, 2024 -
SPSS : descriptive and analytical statistics
Faculté de Médecine de SfaxNov, 2013- Nov, 2024
Experience
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Eshmoun Clinical Research
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Tunisia
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Senior CRA
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Mar 2022 - Present
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Freelancer- Self employed
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United States
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Technology, Information and Internet
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700 & Above Employee
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Clinical research specialist
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Nov 2020 - Dec 2022
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Poseidon CRO
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Hungary
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Biotechnology Research
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1 - 100 Employee
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Clinical Research Associate/ Regulatory Affairs Specialist
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Mar 2014 - Mar 2020
- Monitoring activities : Preparation and conduct of site qualification, initiation, routine monitoring and close-out visits. - Study documents and tools conception. - Junior CRA training (GCPs, therapeutic area and study specific). - Project management : *Development and implementation of monitoring plan and other project plans. *Plan and oversee the site activation process. *Elaborate and update study trackers. *Client Reporting: Review and approve monitoring reports, centralization data/reports from all CRAs in all sites and mailing to the client, . -Regulatory affairs specialist: Submission to CA, training on regulatory affairs - Pharmacovigilance activities : SAEs reporting procedures, SDV, reconciliation - Patient support programs (PSP) - Quality assurance activities: Redaction and update of SOPs, organization of Audits - Data management activities : Coordination, DB cleaning, DB organization, validation plan, Data review and check, support for the processing of data queries, -Statistical analysis : conception of SAP, Statistical Analysis of study data and redaction of SAR. - CRF development : CRF and eCRF creation - Medical writing: protocol redaction, redaction of CSR, scientific articles Show less
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Assistante en pharmacie
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Oct 2012 - Oct 2012
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Ecole des cadres
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Sfax, Tunisie
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Chargée d'enseignement de TP pharmacie galénique
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Oct 2011 - May 2012
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Education
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Faculté De Pharmacie de Monastir
Docteur en pharmacie, Pharmacie -
Faculté de Médecine de Monastir
CEC pharmacologie et marketing pharmaceutique