Clinical Research Training for Senior CRAs – Blended
Book a session
| Date | Product | Location | Price | |
|---|---|---|---|---|
| 09/10/2023 | Clinical Research Training for Senior CRAs | Brussels | EUR 1250.00 | Book |
| If you would like to have this course as an in-house session click here | ||||
About this course
Reasons to attend
Do you want to refresh and improve your CRA skills? Do you need some inspiration to boost your clinical trial monitoring techniques and approach? This CRA Training provides for experienced monitors the knowledge and advanced skills to deal with more complex clinical trials and site management issues. This training, supported by eLearning, provides the best outcome allowing you to learn at your own pace. Increase your odds of becoming a senior CRA with this training.
What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
- This course has been granted PharmaTrain Recognition
Course schedule
This course is a blended learning course, which means it is broken into two parts. The eLearning session must be attended before the face to face training as its content fits to the practical approach during face-to-face training.
Classroom with eLearning:
| Webinars with eLearning:
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Course Description
Through an interactive approach, in this blended learning course, you receive a concise update of the current European clinical trial legislation and you will learn more about clinical trials in developing countries. The critical milestones of clinical trials, contingency plans, dealing with non-compliances, risk-based monitoring, your relationship with the investigator, and coaching junior CRAs are the main topics of this course.
The live session (F2F or webinar) will implement the eLearning material in practice: how to upgrade monitoring methods and skills, how to select the right investigators, how to boost subject recruitment, how to detect and correct informed consent issues, how to solve site management matters and how to deal with non-compliance. You gain insights in developing monitoring plans, tracking tools, accurate monitoring visit reporting, and corrective and preventive actions. You will be reviewing cases from real-life situations during workshops. Lively discussion and action planning involving real-life cases in the live session is one of the main learning areas. Here you will benefit not only from the trainers but also learn from each other’s experiences.
Programme highlight
- Importance of international research – the role of the ICH process
- Update on overview of the current European legislative requirements, including guidance on substantial trial modifications
- Questions and Answers on monitoring plan
- Selection of the right investigator
- The informed consent: process verification
- Improving subject recruitment and tips for site staff to enhance subject retention
- Upgrading monitoring tasks: prioritising monitoring activities, accurate monitoring reporting, efficient tracking, dealing with non-compliances
- Coaching junior CRAs.
Learning objectives
- Be up-to-date on current European legislative rules
- Manage investigational sites effectively from screening to database lock
- Take the right actions to resolve site issues, ascertain appropriate corrective and preventive actions
- Expand your knowledge and improve your monitoring skills
Who should attend
Clinical Research Associates (CRAs) with minimum of 2 years of experience, who want to boost their CRA skills and to set new objectives in their career and/or experienced people working in clinical data processing, biostatistics, regulatory affairs, etc. If you have a particular interest in clinical trials with medical devices, you may prefer to attend our “Running Medical Devices Trials” course.
Competencies
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (0)
- Ethical & Participants Safety Considerations (5)
- Investigational Product Development and Regulation (4)
- Clinical Studies Operations (GCPs or ISO 14155) (7)
- Study and Site Management (5)
- Data Management and Informatics (5)
- Leadership and Professionalism (3)
- Communication (3)
- Teamwork (0)
- Business acumen (0)
Be aware that attending one of ECCRT open course does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained
Trainers
Ms. Jolanda Schavemaker
Trainer
Mirjam Hoefkens
AMC
There was a lot of room for discussion. And the fact that we did take an online training course prior to the classroom meeting, gave the impression all trainees started from more or less the same level of theory knowledge.
Lucie Mortiaux
Nyxoah SA
The many workshops and quizzes in this course made the learning experience great, because they allow a better comprehension of the theory.
Michelle Timmermans
Clinical Trial Center Maastricht (CTCM)
The content of the course was very useful and clearly explained (although we do also monitor lots of non-interventional studies, Marleen took the time to discuss the application of GCP to these non-interventional studies) - Clear workshops to think about topics in an active manner (instead of just listening).
Loes Bastings
Clinical Trial Center Maastricht (CTCM)
Good trainer who applies training material into practice which is applicable for our organization (real life examples) - Marleen took time to discuss items which were not clear for us and she used examples from our type of studies to explain the study material.
Nienke Cuperus
Axelle Vankemmel
Cathy Schummer
Anonymous