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
- 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.
- 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