Planning and conducting Phase I-IV clinical trials in humans
Overview
Approved for delivery on the 28/06/2018, the clinical trials specialist (degree), Higher apprenticeship standard provides a level 6, non-integrated degree upon completion. This apprenticeship will typically take 60 months to complete, not including the End-Point Assessment Period.
What the course covers
The Clinical Trials Specialist degree apprenticeship will provide you with the experience working in both public and private clinical research organisations, as part of a multi-disciplinary team, planning the delivery and executing Phase I-IV clinical trials in humans.
Taking the responsibility of ‘site monitor’, you will oversee all stages of the trial from development through to completion, developing plans and implementing strategies that ensure the accuracy and quality of the recorded data and observations. You will learn to report compliance deviations such as Serious Breaches and Product Complaints, and complete the appropriate documentation complying with industry regulations and legislation.
You will develop a strong base of scientific knowledge to conduct clinical trials, including physiology, pharmacology, biochemistry and genetics and understand the principles of Good Clinical Practice (GCP) and the wellbeing of patients.
You will use a variety of trial systems including electronic Clinical Trial Management Systems (eCTMS), electronic Case Report Forms (eCRF), Interactive Response Technology (IRT), and electronic Trial Master Files (eTMF), as you write comprehensive clinical study reports use strong communication skills to present your findings and answer questions with confidence.
Careers and jobs associated
- Clinical Trials Director
- Study Coordinator
If you would like to find out more about this apprenticeship standard, including possible duties of the role, skills and assessment method visit the Institute for Apprenticeships.
