Clinical Research Associate (CRA) Beginners Online Course

A clinical Research Associate (CRA) primarily manages the managerial aspects of a number of clinical trials, at every stage of the process.

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. You may be a research nurse or a former data manager who has landed their first role as a CRA. 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.

• CRA Beginners Course - > download

This is a course that focuses on current clinical practises to ensure the delegate develops a thorough insight on the role of a CRA. Participants will learn about the role and responsibilities of the clinical research associate in the context of the regulations and rules that govern clinical trials. There will be discussions concerning real life settings as well as case scenarios will be adopted. A look at the ‘day in the life of a CRA’ will provide further insight into the profession. Mock up sample protocols, and study documents will be reviewed and practically used throughout the course to reinforce the learning concepts. There will be an assessment at the end of the 3 weeks with a pass mark of 70%

CRA CLINICAL RESEARCH ASSOCIATE

Are you a CTA looking to advance to a CRA level? Are you a CRA with limited experience seeking training to improve your skills and performance? Are you a Research Nurse or Data Manager who has landed your first CRA role? If so, this Clinical Research Associate course provided by CGX Training is an excellent starter course that can equip you with the skills to conduct clinical trial initiation and or/ monitoring and basic site management at the investigator site.

A CPD accredited 3-week, part-time intensive course which provides those starting or looking to improve their skills as a CRA with a comprehensive and valuable insight into the entry-level role of a Clinical Research Associate (CRA).

A clinical Research Associate (CRA) primarily manages the managerial aspects of a number of clinical trials, at every stage of the process.

This is fundamentally a “practical” and “hands on” workshop that focuses on current practice to ensure the CRA delegate develops practical experience of the role. Participants will learn about the role and responsibilities of the clinical research associate in the context of the regulations and rules that govern clinical trials.

TOPICS

• ICH- GCP
• The primary duties of a CRA
• The specific responsibilities in accordance with ICH-GCP, SOP and regulations:
• Before the clinical phase of the trial commences
• During the clinical conduct of the trial
• After completion or termination of the 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 close out activities

Who is the course Designed For?

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 this modular training is specifically designed for you. You may be a research nurse or a former data manager who has landed their first role as a CRA. 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.

How will I benefit from taking this course?

• Identify suitable Investigator for participate in a clinical trial.
• Perform pre-selection visits to assess the suitability of a site to conduct the trial.
• Understanding of what essential study documentation necessary are required start a trial
• Conduct Pre-trial procedures including drug release IP
• set up Investigator sites for conduct of the study
• Conduct an initiation visit
• Monitor the conduct at the investigator site
• Review source documentation and site file review
• Perform site management activities
• Conduct a close-out visit at the end of the study.
• Complete a clinical trial

Minimum entry requirements: 5 GCSE passes one in a science subject.

CRA - Clinical Research Associate

CPM - Clinical Project Manager

Certificate of completion

Digital certificate - Included