Clinical Trials Specialist Degree Apprentice UNIVERSITY OF BIRMINGHAM

The apprentice will learn to coordinate one or more designated clinical trials according to predefined standards, policies, procedures, frameworks and legislation, ensuring appropriate records are kept. To support this the apprentice will study the Clinical Trials Specialist degree apprenticeship, achieving a BSc (Hons) Applied Bioscience., Set up clinical sites (including feasibility and site selection), support ethics committee and regulatory submissions, ensuring that staff at participating sites understand and are able to comply with the trial protocol.

Support each site with recruitment and monitor the progress of each site, including trial protocol compliance. Record and report compliance deviations such as Serious Breaches and Product Complaints.

Set up and maintain Trial Master File(s).

Prepare, perform and follow up on on-site initiation, monitoring and close out assessments (including visits) following the CRCTU Standard.

Operating Procedures (SOPs) to assess patient recruitment and compliance with trial procedures and the quality and timelines of the data collection. During visits, review the trial related documents, perform source data verification and visit other departments involved in the trial such as pharmacy.

Raise any discrepancies, issues or concerns with the site staff and use own initiative to resolve issues locally.

Write initiation, monitoring and closure (visit) reports and follow-up letters to sites confirming details of what was done, agreed and discussed, and any problems or remaining queries to be addressed.

Address any practical issues reported by sites.

Contribute to the design, analysis, publication and presentation of the research. This may involve supporting the design, development and feasibility testing of protocols; patient facing documents; risk assessments; case report forms; coding lists and databases (including user acceptance testing); contribute to abstracts, posters and journal articles.

Provide regular feedback and reports on the progress of the trial, including newsletters, meetings, maintaining a trial website.
Ensure trial data is collected, processed and stored accurately and to agreed deadlines.

Train other internal and external collaborators involved in data management in the rules and procedures to use.
Create and document guidance notes, procedures and forms for the conduct of the trial, and ensure internal and external collaborators are trained to understand and follow them.
Create and maintain trial management tools including databases to allow sample tracking and Investigational Medicinal Product management.
Develop a data management plan and enter trial data onto the trial database(s), and monitor it to identify missing, contradictory or incorrect data and then take actions to resolve these issues within a reasonable timescale.
Coordinate and support the trial management group and oversight groups and organisations.

Upon successful completion, the apprentice will have achieved a BSc (Hons) Applied Bioscience or BSc (Hons) Applied Bioscience with Clinical Research Operations., Communication skills, IT skills, Attention to detail, Organisation skills, Customer care skills, Problem solving skills, Presentation skills, Administrative skills, Number skills, Analytical skills, Logical, Team working, Initiative, Non judgemental, Patience, GCSE or equivalent English (Grade C or above (4-9)) Essential
GCSE or equivalent Mathematics (Grade C or above (4-9)) Essential
A Level or equivalent Biology (Grade C or above) Essential

A world top 100 university and part of the prestigious Russell Group, the University of Birmingham makes important things happen. Delivering groundbreaking research and excellent research led teaching. People are at the heart of what we are and do. The University of Birmingham is proud to have been a part of the City of Birmingham and the wider region for over 100 years, and we are equally proud to be recognised as a leading global university. We want to attract talented people from across the city and beyond, support them to succeed, and celebrate their success. We are committed to helping the people who work here to develop through our sector-leading Birmingham Professional programme which provides all professional services staff with development opportunities and the encouragement to reach their full potential. With almost 5,000 professional services jobs in a wide-range of functions in Edgbaston and in our campus in Dubai, there are plenty of
opportunities for you to be able to develop your career at the University. We believe there is no such thing as a typical member of staff and that diversity is a source of strength that underpins the exchange of ideas, innovation, and debate. We warmly welcome people from all backgrounds and are committed to fostering an inclusive environment where diversity is at the heart of who and what we are, and how we work. Supporting our people to achieve a healthy work/life balance is important both to our employees and to the success of the University and, depending on the role, we offer a variety of flexible working arrangements. We therefore welcome discussions on all forms of flexible working. In addition, you will receive a generous package of benefits including 40 days paid holiday a year, one paid day a year for volunteering, occupational sick pay, and a pension scheme. We also have three high quality subsidised day nurseries. The University
is situated in leafy Edgbaston and there are excellent transport links to our beautiful campus, including main bus routes and a train station on site. On campus we have a state-of-the-art sports centre with pool, shops, places to eat and drink, our own art gallery, museum, and botanical gardens.

Cell Biology
Applied Chemistry
Biochemistry
Microbiology
Regulation of Clinical Research

• 
  Introduction to GCP and GxP
• 
  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
  
  They then choose three optional modules from the list below:
  
  Nanomedicine
  Biopharmaceuticals and Gene Therapy
  Clinical Pharmacology
  Advanced Immunology and Microbiology
  Advanced Therapeutic Agents
  Advanced GI and Endocrinology
  Frontiers in Oncology and Haematology
  Advanced CV and Respiratory Physiology
  Advanced CNS Physiology and Ophthalmology, You could reduce your training time, or finish your apprenticeship faster, if you have relevant prior learning or experience. This could be relevant:
  
• training


• qualifications, like an NVQ in a relevant field


• industry or sector experience


Apprenticeship standard

Clinical trials specialist (degree)

Level 6 (Degree with honours)