Clinical Research Associate Training
Duration: 40 CPD Hours
The role of a Clinical Research Associate involves the following:
- Involved in all stages of the clinical trial, including identifying an investigational site and setting up, initiating, monitoring and closing down the trial.
- May be assigned at feasibility stage
- Establish relationships with Key Opinion Leaders
- Developing and writing clinical trial protocols
- Attending Investigator Meetings
- Presenting trial protocols to a steering committee
- Designing data collection forms, known as case report forms
- Coordinating with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects
- Managing regulatory authority applications and approvals that oversee the research and marketing of new and existing drugs
- Identifying and assessing the suitability of facilities to be used as the clinical trial site
- May or may not be therapeutically aligned
Clinical Research Course description:
Designed for those that have none or very little experience of in the field of clinical research (BSc or Post Graduate qualification required- Nursing or Science). Following completion of this course you will be able to work effectively as a member of the Clinical Research Teams as a Clinical Research Associate within organisations. You will gain a firm knowledge and understanding of of the tasks of CRA's globally. Estimated completion time 40 hours on-line.
Elements covered in this clinical research course:
- Good Clinical Practice
- Phase I Clinical Studies
- Phase II-IV Clinical Studies
- Pharmaceutical Industry and Outsourcing
- Essential Documents
- Protocol, Investigators Brochure and Case Record Form
- Clinical Study Monitoring Plan
- Regulatory Affairs (IND & Regulatory Submissions)
- Ethics Committees & Submission process
- Adverse and Serious Adverse Events discussion and training
- Investigator and Site responsibilities
- Managing recruitment and identifying issues
- Informed consent process
- In depth training on Clinical Research Associate monitoring skills
- Training of tasks commonly assigned to Clinical Research Associates
- Preparing for an Audit
- Other Roles within the pharmaceutical industry
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