Introduction to Clinical Research Management

Description
Operational

Due to the current restrictions, this course will be provided as 4 live-online sessions of 2 hours at the following dates:

  • 28 April from 10:00am – 12:00pm
  • 12 May from 10:00am – 12:00pm
  • 18 May from 10:00am – 12:00pm
  • 26 May from 10:00am – 12:00pm

Sessions are to be booked as one package, and cannot be booked separately.

A sponsor conducting clinical trials has important responsibilities as per ICH GCP E6 R2, which are up for audit and inspection reviews, ensuring patient safety, rights and well-being, data quality and regulatory compliance.

It is therefore key that these requirements are not just known to management and the research staff, they also need to provide evidence of in-depth understanding, accurate application and compliance in a documented format per the level of risk of the trial and within their realm of involvement in the trial.

This course covers the different aspects of the operational management of a clinical trial, including the review of the applicable regulations and the overview of day-to-day responsibilities of each member of the clinical team (CRA and project manager) through theory and interactive discussions.

Slides, useful documentation, a training sign-in sheet and certificate are included.

Learning objectives

By the end of this TRIUM Training you should be able to:

  • Describe the applicable regulations for clinical trials
  • Explain the informed consent process
  • Define monitoring responsibilities in clinical trials
  • Define project management responsibilities
  • Ensure protocol compliance and overall quality
  • Establish project oversight
  • Manage study budget and deliverables effectively
Intended audience

Skilled Level
Can perform task or skill independently, consistently, accurately, and has a moderate level of expertise. Efficient and high quality work. Able to independently navigate resources and uses tools well.

Trainer
Gerald Van Roey
Gerald Van Roey MPhEd had over 10 years of experience in Clinical Operations before switching his career into the training business in 2009. He has worked as trainer and managing director for the ECCRT, European Centre for Clinical Research Training before starting his own company in 2015. As a clinical monitor he performed more than 40 studies in areas including pharmaceutical, biotechnology and medical devices in all stages of clinical development. In his previous career he implemented different trial tools and mentored many junior CRAs. His extensive knowledge and background serves him as a manager and trainer for different courses. In his trainer function he has coached over 1000 clinical research professionals and has delivered courses in 14 different countries.