CLINICAL RESEARCH ASSOCIATES CRA Beginners

Fri Mar 15 2019 at 09:30 am to Sun Mar 17 2019 at 04:30 pm
Citadines Holborn, 94-99 High Holborn,, London, United Kingdom

Citadines Holborn, 94-99 High Holborn,, London, United Kingdom

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

Accredited classroom based training - Duration 3 days. The role of the CRA will be covered in intensive detail with visual aids and hands-on training provided by experienced industry professionals.

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.

Responsibilities


Identification of Investigator and selection of sites to participate in a clinical trial.

Perform pre-selection visits to assess the suitability of a site to conduct the trial.

Collation of essential study documentation necessary to start a trial

Co-ordination of ethics committee and regulatory authority applications and approvals

Pre-trial procedures including:-

set up Investigational sites for conduct of the study

Conduct an initiation visit

Monitor the conduct at the investigational site, conduct source documentation verification and site file review.

Perform site management activities e.g. oversight of study conduct at site, drug accountability and site file review, query and issue resolution.

Conduct a close-out visit at the end of the study.


Further responsibilities


Organisation, attendance and/or presentations at investigator meetings

Training site staff to trial specific and industry standards

Supervision and/or distribution of trial supplies, including the trial drug (investigational medicinal product)

Assist with archiving of trial documentation and correspondence

Assist with the Clinical Trial Report and manuscript for publication

Development of the clinical trial protocol and Case Report Form (CRF) development and informed consent form.


Who is the course Designed For?

If you are a clinical trial administrator who has just been promoted to a CRA level 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.
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Created By:
CGX Training
Spread the word