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Clinical Trials Specialist

Clinical Trials Specialist

On a clinical trials specialist apprenticeship course, you’ll help deliver and execute phase one-to-four clinical trials in humans.

Clinical trial experts work in government or private clinical research organisations, mainly in the pharmaceutical or biotechnology industries. You will be part of a multidisciplinary team in charge of delivering and executing phase one-to-four clinical trials in people.

You’ll start with a lot of monitoring since that’s what external regulations need. Still, as time passes, you’ll get greater authority to oversee and execute clinical studies on time and on budget.

As a clinical trials specialist apprentice, you will spend most of your time at an office. However, still, you’ll visit other institutions (hospitals, pharmacology units, and general practitioners) to perform monitoring activities.

You will get a degree in biological science after finishing this apprenticeship.

What you’ll learn

On a clinical trials specialist apprenticeship course, you’ll learn to:

  • Create, develop, and implement centralised and site monitoring techniques. 
  • Conduct SDV and develop a clinical trial recruitment strategy. 
  • Assess trial location suitability based on a complete understanding of protocol requirements, and create applicable feasibility surveys at the national and site levels. 
  • Carry out all site monitoring activities in compliance with national and local requirements, including site selection, start-up, maintenance, and closure. 
  • Utilise clinical system information to assure trial data accuracy and timeliness.
  • Use electronic Clinical Trial Management Systems (eCTMS), electronic Case Report Forms (eCRF), Interactive Response Technology (IRT), electronic Patient/Physician Reported Outcomes (eP/PRO) systems, and electronic Trial Master Files in clinical trials (eTMF). 
  • Create documentation to aid in installing, programming, maintenance, and oversight of these systems in compliance with the protocol and Good Clinical Practice.
  • Make effective project plans that include scope, timing, and risk management. 
  • Team activities must be coordinated to meet project objectives and quality standards. 

Entry requirements

You’ll usually need:

  • Level 3 qualifications and one A-level in one science subject, or equivalent qualifications.
  • Apprentices without level 2 English and maths will need to achieve this level before taking the end-point assessment.

Assessment methods

The End Point Assessment consists of two distinct assessment methods: 

  • A Synoptic Project Report based on a Clinical Study Project. Linked with presentation and Question and Answer (Q and A) based on the Synoptic Project Report evidence.
  • Professional Discussion underpinned by a Vocational Competency Log.

Duration and level

  • Duration: 60 months
  • Level: 6 – Degree Apprenticeship

Apprenticeship standard

More information about the Level 6 Clinical Trials Specialist Apprenticeship standard can be found here.

Apprenticeship end point assessment

For more information about the End Point Assessment Process, please read the Institute of Apprenticeships’ information page.

Updated on October 1, 2022

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