3-Week Clinical Research Associate (CRA) Online Beginner Course with Scenario-based Training and Group Workshops

2023-06-30

高管变更临床研究

DUBLIN, June 30, 2023 /PRNewswire/ -- 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.

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.

Training Details

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

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 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/n9lkn5

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SOURCE Research and Markets