Comprehensive Curriculum

Gain in-depth knowledge and practical skills in clinical research auditing

Expert Guidance

Learn from a prior U.S. FDA Investigator with years of experience in the field

Career Advancement

Boost your career prospects with a training certificate in quality assurance clinical research auditing

About the Course

Target Audience

Individuals with or without prior training and experience as a QA Auditor; Bachelor's degree minimum education requirement

Comprehensive Content

Embark on a transformative journey to become a Clinical Research Professional with our comprehensive course. Dive deep into the world of clinical research auditing and equip yourself with the necessary skills to excel in this dynamic field. 

Active Learning

Our expert-led curriculum is designed to provide you with practical knowledge and hands-on experience, ensuring you are well-prepared for a successful career in quality assurance.

Course Curriculum

5 Chapters · 5 Lessons

  1. 1

    Introduction to Clinical Research Auditing

    1. (Included in full purchase)

      Roles and Responsibilities in Auditing

  2. 2

    Auditing Process Overview

    1. (Included in full purchase)

      Conducting an Audit

  3. 3

    Compliance and Quality Assurance

    1. (Included in full purchase)

      Implementing Quality Assurance Practices

  4. 4

    Practical Auditing Skills

    1. (Included in full purchase)

      Effective Reporting Techniques

  5. 5

    Advancing Your Career in Clinical Research

    1. (Included in full purchase)

      Networking and Career Opportunities

About the Creator

Dr. Alia Legaux is a former U.S. FDA Investigator with more than 24 years of experience monitoring, inspecting and/or auditing of FDA regulated entities, such as Clinical Research Investigator Sites, Clinical Research Organizations (“CROs”), Sponsors, Ethics Committees, Vendors (i.e. safety reporting, laboratory testing, data management, biostatistics, programming, electronic data capture, interactive voice response services, electronic clinical outcome assessments, central reading and imaging), Compounding Pharmacies, Blood Banks, and/or Tissue Banks. As an Independent Consultant, Alia provides expertise in quality assurance and compliance. She conducts domestic and international routine, directed (for-cause), qualification, re-qualification, and inspection readiness audits, as well as mock inspections of investigator sites, CROs, Sponsors, vendors, compounding pharmacies, drug manufacturers, packagers, or labelers to assess compliance with applicable regulations, protocols, investigational plans, Standards Operating Procedures (“SOPs”), International Conference on Harmonization (“ICH”) Good Clinical Practice (“GCP”), Good Manufacturing Practice (“GMP”), Good Laboratory Practice (“GLP”), Good Clinical Laboratory Practice (“GcLP”), and Good Pharmacovigilance Practice (“GVP”). Alia shares her knowledge in the varied training courses offered by CRSC.

Start Your Journey Today

Unlock the doors to a successful career in clinical research auditing. Enroll now and take the first step towards becoming a Clinical Research Quality Assurance Professional.

$2,799.00

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