Degree Apprenticeship - Birmingham, United Kingdom - University of Birmingham

University of Birmingham

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Birmingham, United Kingdom

2 weeks ago

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Tom O´Connor

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Description

Position Details
College of Medical and Dental Sciences

Location:
University of Birmingham, Edgbaston, Birmingham UK

Full time starting salary is £20,405. per annum rising to £25,506. per annum after 12 months in post.

Apprentice Band 500

Full Time / Fixed Term Contract for 60 months

Apprenticeship Standard:
Clinical Trials Specialist Degree Apprenticeship

Degree Apprenticeship Training Provider:
University of Kent

Closing date: 30th July 2023

Apprenticeship Context

This 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.

Degree Apprenticeship summary

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.

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 onsite 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 followup 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