CLINICAL RESEARCH ASSOCIATE (CRA) - (BEGINNERS)
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.
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.
- 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.
- 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.
What will be covered in this course?
- 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