Clinical Trials Specialist

A Clinical Trials Specialist works in both public and private research organisations, generally in the pharmaceutical or biotechnology industries.

Join our Clinical Trials Drop in Session on the 31st of May at 2pm to meet our Academic experts and Business Development. 

To request an invite please follow this link - Microsoft Form

Our Clinical Trials Specialist degree apprenticeship (Level 6) works in collaboration with Clinical Professionals Ltd and aims to advance the skills of those in the field and attract new staff. It is suitable for people who work as part of a team which focuses on the delivery and execution of Phase I-IV clinical trials. 

This apprenticeship is for people working as part of a multidisciplinary team in private or public clinical research organisations within pharmaceutical or biotechnology industries. They will usually be office-based but may travel to sites (hospitals, pharmacology units and General Practitioners) to conduct monitoring activities. Typical roles may include:  

  • Clinical Trials Assistant 
  • Clinical Trials Administrator 
  • Clinical Research Associate  
  • Study Co-ordinator with development to Clinical Project Manager 

Benefits of the programme   

At Kent, we have an experienced team with a wealth of expertise in apprenticeships in health and science. We can provide advice and support on all aspects of the process from advertising the vacancy and funding, to workplace monitoring and end-point assessment requirements. Our award-winning blended learning approach, combining e-learning and block teaching, allows your apprentices to thrive in the workplace while gaining a degree.    

We work with employers nationwide, of any size, to fill a skills gap in their business. You employ the apprentice directly or via an Apprenticeship Training Academy and we work with you to:  

  • provide an academic programme of study (20% of the apprentice’s paid hours should be spent completing off-the-job training)  
  • design on-the-job training plans  
  • support you and your apprentice with workplace visits. 

The curriculum is carefully planned and sequenced to ensure that the learners acquire the Knowledge, Skills and Behaviour defined by the Clinical Trials Specialist standards, published by the Institute for Apprenticeships and Technical Education (IfATE)*, and combines academic study and learning from the workplace.  

Clinical trials are centred around testing the safety and efficacy of new drugs and medical devices, and therefore there are three pillars to the programme: 

  1. The basic biology related to health sciences (providing the building blocks of life and the genetic or environmental changes that affect human health) 
  1. The regulatory landscape that surrounds clinical trials (approval and auditing, protection of participants and pharmacovigilance, licensing) 
  1. The economical and business related aspects of clinical trials (for instance, health economics, business environment, and project management) 
Amy Kirby, Clinical Trials Specialist Apprentice alumna

Amy Kirkby went straight from A levels into a Clinical Trials Specialist degree apprenticeship with the University of Kent.  

Read what she says here. 

Qualification   

Upon successful completion, the apprentice will have achieved a BSc (Hons) Applied Bioscience or BSc (Hons) Applied Bioscience with Clinical Research Operations.

Duration and commitment   

There is a 54-month delivery with 6 months for End-Point Assessment (EPA).

Entry requirements   

At least five GCSE passes (or equivalent), including English Language and Mathematics at grade 4 or above. They are also required to have achieved at least two subjects at A Level (or equivalent), including Chemistry / Biology. Alternatively, applicants must have completed a Level 3 Laboratory Technical Apprenticeship in a relevant science discipline. 

Applicants that do not meet the entry criteria however have workplace experience will be considered on a case by case basis.    

Modules 

Level 4 
3 Day Residential 
Cell Biology  
Introductory Chemistry for Biologist
Biochemistry 
Microbiology 
Good Clinical Practice, Regulations and Ethics Committees
Human Physiology and Disease  
Metabolism and Enzymology 

Level 5 
Data Management and Statistics 
Critical Thinking
Applied Microbiology 
Infection and Immunity 
Pharmacology 
Pharmacovigilance
Documentation Management, Quality Management Systems and Biological Sample Management 
Project Management and Decision Making

Level 6 
Finance and Corporate Governance
Health Economics
Company-based Research Project 
3 out of 7 Optional Modules from the below:
Nanomedicine 
Biopharmaceuticals and Gene Therapy 
Clinical Pharmacology  
Advanced Immunology and Microbiology 
Advanced Therapeutic Agents 
Oncology and Haematological Malignancies 
Advanced CV and Respiratory Disease


Fees and funding 

The cost of the programme is £26,000 per apprentice and this can be paid for from the apprenticeship levy or by government co-investment funding which covers up to 95% of the fees. There is also the cost of accommodation and travel for Summer Schools. This should be funded by the employer and is not payable from apprenticeship levy or government funding. 

Start dates 

We offer start dates in September, October, January, and May for this programme. The cut-off for applications is normally one month prior to the start of the course.

Employers and Employees

Our team are there to offer support with developing apprenticeships in your organisation, be it upskilling existing employees or recruiting for new roles.

Contact us by emailing recruitapprenticeships@kent.ac.uk or by calling 01634 888467 (9:30am - 4pm Monday to Friday).

Students and Prospective Apprentices

Apprenticeships are available to those already employed in a relevant position and require the support of an employer to take part. If you are not already employed in a relevant role, please visit our please visit our Becoming an Apprentice page.  


 

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