Summary
Overview
Work History
Education
Skills
Languages
Timeline
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Nabila MENASRIA

Summary

Proven expertise in clinical research and regulatory affairs, honed at CRA School and Axelys Santé. Proficient in ICH Good Clinical Practices, with meticulous attention to detail, demonstrating a strong commitment to advancing medical research while upholding regulatory and ethical standards.

Overview

4
4
years of professional experience

Work History

Clinical Research Associate Trainee

CRA School
03.2024 - 08.2024
  • Worked on three studies (Phase II and III) across various therapeutic areas, including metabolic syndrome, cardiovascular risks and oncology.
  • Familiarized with essential trial documents, including protocol/protocol synopsis, informed consent form (ICF), case report form (CRF) design, investigator brochures (IB), and other related materials, which are organized in the Trial Master File (TMF)/ Investigator Site File (ISF).
  • Prepared for trial monitoring visits, including Site Qualification Visits (SQV), Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and Close-Out Visits (COV).
  • Skilled in CRF data entry, Electronic Data Capture (EDC), and Clinical Trial Management System (CTMS).
    Monitored subject protocol compliance and conducted source document verification (SDV).
  • Trained in the completion of U.S. and Canadian regulatory and ethics forms, such as FDA Form 1571/1572 and QIU Form, as well as adverse event (AE) and serious adverse event (SAE) reporting.
  • Completed the Canadian Tri-Council Policy Statement (TCPS 2) training.

Regulatory Affairs Officer

Axelys Santé
07.2022 - 10.2023
  • Prepared and submitted study packages for several trials to the Algerian regulatory authority (RA) and ethics committee (EC).
  • Followed up on approvals.
  • Submitted potential notifications and amendments to the regulatory authority (RA) and ethics committee (EC).
  • Closely monitored local requirements for clinical trials and safety reporting.
  • Submitted import/export licenses for investigational products and biological samples to the local regulatory authority.
  • Participated in the drafting and updating of Standard Operating Procedures (SOPs).

Customer Satisfaction Officer

Somepharm Distribution
10.2021 - 07.2022
  • Planned and organized customer satisfaction surveys with pharmacy staff.
  • Analyzed the surveys results.
  • Proposed CAPA plans based on the findings.

Regulatory Affairs Trainee

Sanofi Aventis
05.2020 - 07.2020
  • Internship in the regulatory department, collaborating with the commercial and medical departments to develop a thesis titled: "OTC Drugs and Self-Medication : What Are the Future Prospects for Algeria?"
  • Familiarized with the pharmaceutical regulatory requirements and the drugs market in Algeria.
  • Proposed guidelines for the regulation of OTC Drugs in Algeria.

Education

Post-Graduated Diploma - Clinical Research

International Clinical Research Academy,CRA School
Montreal, QC
09.2024

Doctor of Pharmacy (PharmD) - Pharmacy

Faculty of Pharmacy Algiers
Algiers, Algeria
11.2020

Bachelor's Degree - Experimental Sciences

Hassiba Ben Bouali High School
Algiers, Algeria
06.2014

Skills

    ICH Good Clinical Practices

    Data Entry

    Electronic Data Capture

    Case Report Forms

    Source Document Verification

    Informed consent

    Adverse event reporting

    Completing regulatory documents

    Attention to Detail

Languages

English
Professional Working
French
Native or Bilingual
Arabic
Native or Bilingual

Timeline

Clinical Research Associate Trainee

CRA School
03.2024 - 08.2024

Regulatory Affairs Officer

Axelys Santé
07.2022 - 10.2023

Customer Satisfaction Officer

Somepharm Distribution
10.2021 - 07.2022

Regulatory Affairs Trainee

Sanofi Aventis
05.2020 - 07.2020

Post-Graduated Diploma - Clinical Research

International Clinical Research Academy,CRA School

Doctor of Pharmacy (PharmD) - Pharmacy

Faculty of Pharmacy Algiers

Bachelor's Degree - Experimental Sciences

Hassiba Ben Bouali High School

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Nabila MENASRIA