Dublin, June 01, 2023 (GLOBE NEWSWIRE) -- The "Clinical Research Associate (CRA) Beginner (Online)" training has been added to ResearchAndMarkets.com's offering.
If you are looking to enter the field of clinical research, this CPD-accredited course is for you. It will provide you with a comprehensive insight into an entry-level Clinical Research Associate (CRA) role.
This fundamental "how-to" and "why" course, focuses on current practice. You will learn about the CRA's role and responsibilities in the context of the regulations and rules that govern clinical trials. You will look at a day in a CRA's life to gain insight into the profession. Alongside this, you will review mock-up sample protocols and study documents to reinforce your learning.
What will be covered in this course?
This module will look at:
- ICH-GCP
- The primary duties of a CRA
- The specific responsibilities in accordance with ICH-GCP
- SOP and regulations for before, during and after a clinical trial
- Essential documents - Preparation, collation and QC
- Ethics and regulatory submissions and approvals of the clinical trial application
- Study start-up activities - site identification and selection, QC for IP release
- Site activation - SIV, ISF review and drug supply review
- Monitoring and site management
- Study site closeout activities
You will also be guided through some real-life practical training that you will experience on the job.
- Scenario based training
- Group workshops
- Review a Monitoring Plan for a clinical trial
- First-hand review and practical use of drug accountability logs, and returned investigational product kits
- Video: A Day in the Life of a Clinical Research Associate
What prior knowledge is needed?
Most CRA positions require as a minimum a BSc in:
- Biological/life sciences
- Pharmacy
- Chemistry
- Related medical field or a nursing qualification
However, in some cases, CRAs have entered the profession without a graduate degree but have relevant expertise. The most important thing is having the right skills for the job.
Duration:
3 weeks, 2 sessions per week for 3 hours each day
Training days:
Mondays and Tuesdays. In the final week, there will be an additional class on Wednesday that will mainly consist of the final assessments.
Training time:
From 2 pm
Who Should Attend:
If you are a clinical trial administrator who has just been promoted to a CRA level I or have limited experience as a CRA, this modular training is specifically designed for you.
This is a good starter course that will equip you with the skills to conduct clinical trial initiation and/or monitoring and basic site management at the investigational site.
Speakers:
Dr. Lia Hunter
Founder and Director
CGX Training and Clinnovate Ltd
With a BSc in Chemistry, PhD in Organic Chemistry and a Postdoctoral Research Fellowship at the Institute of Biotechnology at Cambridge University, Dr Lia Hunter's career has spanned 30 years in clinical research. Founder and Director of both CGX Training and Clinnovate Ltd, Dr Hunter has worked for and with world-renowned pharmaceutical organisations, including Pfizer, Biogen, Takeda and AbbVie.
Donna-Marie Donalds
QC Monitoring Solutions
Donna-Marie Donalds' career has spanned more than 20 years. Starting as a CRA for the Thrombosis Research Institute in 2001, she has since worked with the likes of Johnson & Johnson, Covance and Sanofi-Aventis. She is currently the Managing Director of QC Monitoring Solutions while freelancing as a clinical research consultant. Donna-Marie is also Head of Training and the innovative course creator at CGX Training.
For more information about this training visit https://www.researchandmarkets.com/r/etlapi
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