Clinical Trials Specialist Apprentice - College of Medical and Dental Sciences - 103916 - Apprentice Grade 5

University of Birmingham

  • United Kingdom
  • £22,718-28,397 per year
  • Contract
  • Full-time
  • 14 days ago
Job Description:Position DetailsCollege of Medical and Dental SciencesLocation: University of Birmingham, Edgbaston, Birmingham UKFull time starting salary is £22,718. per annum rising to £28,397. per annum after 12 months in post.Apprentice Grade: 5Full TimeFixed Term contract for 60 monthsClosing date: 9th June 2024Apprenticeship:Training Provider:Our offer to youPeople 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.Find out more about theApprenticeship ContextThis is an exciting opportunity to join one of the largest UK Cancer Research Collaboration (UKCRC) registered clinical trials unit in the country. The Cancer Research UK Clinical Trials Unit (CRCTU) is based in the Institute of Cancer and Genomic Sciences and specialises in running cancer clinical trials. The Unit has an extensive portfolio of phase I, II and III clinical trials in adults and children covering a wide range of cancer disease sites. The Unit also specializes in the delivery of non-cancer early phase trials including trials testing devices and biomarkers. The CRCTU receives substantial core funding from Cancer Research UK and additional funding from other charities, government and pharmaceutical companies and employs a multidisciplinary team of over 180 members of staff.Apprenticeship summaryThe 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.This role will typically work alongside a Trial Administrator and Data Manager, and report to a Senior Trial Coordinator who in turn report to the relevant Trial Management Team Leader.Main duties the apprentice will learn include: * 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.
  • Represent the trial management team at meetings.
  • Keep up to date with the current research literature and developments in the field.
  • Present and give talks on the clinical trial within the University and at scientific and collaborator meetings.
  • Ensure the clinical research is undertaken according to applicable standards, policies, procedures, frameworks and legislation.
  • Promotes equality and values diversity acting as a role model and fostering an inclusive working culture.
Required Qualifications and Skills
  • At least five GCSE passes (or equivalent), including English Language and Mathematics at grade 4 or above.
  • At least two subjects at A Level (or equivalent), including Chemistry or Biology. Alternatively, applicants must have completed a Level 3 Laboratory Technical Apprenticeship in a relevant science discipline.
  • Demonstrable evidence of an interest in a career within Clinical Trials
  • Good IT literacy
  • The ability to work effectively as a member of a team towards quality service goals and deadlines.
  • Good oral and written communication
  • Ability to prioritise and schedule workload in the face of conflicting demands.
  • Structured and methodical approach to problem solving.
  • A willingness to adopt and champion new ways of working.
  • Understands the importance of equality and diversity in the workplace
  • Ability to identify and respond to equality and diversity issues in line with relevant policies and procedures
Informal enquiries to Sonia Fox,View our staff values and behavioursWe believe there is no such thing as a 'typical' member of University of Birmingham staff and that diversity in its many forms is a strength that underpins the exchange of ideas, innovation and debate at the heart of University life. We are committed to proactively addressing the barriers experienced by some groups in our community and are proud to hold Athena SWAN, Race Equality Charter and Disability Confident accreditations. We have an Equality Diversity and Inclusion Centre that focuses on continuously improving the University as a fair and inclusive place to work where everyone has the opportunity to succeed. We are also committed to sustainability, which is a key part of our strategy. You can find out more about our work to create a fairer university for everyone .

University of Birmingham