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EPharma Global

EPharma Global

EPharma Global

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


Enrol for Critical research Associate Training