Trial Coordinator - Cancer Clinical Trials Unit (CRCTU)- 108098 - Grade 6

This is a part-time, fixed-term Trial Coordinator position focusing on the management and administration of clinical trial protocols. Key responsibilities include ensuring protocol adherence, regulatory compliance, site setup, data management, and contributing to research publications. Requirements include a higher degree or equivalent experience in clinical research, strong data management skills, and proficiency with statistics packages.

• Ensure that the trial protocol is conducted in accordance with the applicable ethical, regulatory and CRCTU quality standards and that appropriate records and audit trails are maintained.
• Ensure that the trial complies with current regulatory reporting requirements (e.g. of adverse events) to the relevant bodies e.g. competent authorities, ethics committees, investigators etc.
• Set up clinical sites, prepare ethics committee and regulatory submissions, ensuring that staff at participating sites understand and are able to comply with the trial protocol.
• Monitor progress of each site and take appropriate action to ensure good recruitment, compliance with the protocol and the quality and timeliness of the data collection.
• Use initiative to tackle any practical difficulties reported by sites i.e. which affect recruitment, protocol or Good Clinical Practice compliance or patient safety.
• Conduct initiation, problem solving, monitoring, quality assurance/audit visits as required.
• Contribute to the design, analysis, publication and presentation of the research. This may involve contributing to the following: writing research grant applications
• designing, developing and feasibility test of protocols
• coding lists and databases
• Responsible for the collection, processing and secure storage of the study documentation.
• Apply in depth understanding of the clinical research to ensure that the methods used to implement and conduct the protocol are consistent with answering the key research questions reliably.
• This will involve developing work plans to translate the major methodological requirements into practice.
• Plans must consider the wider implications i.e. to colleagues, CRCTU policy, Good Clinical Practice, quality management, feasibility, costs and deadlines.
• Organise and administer the larger, external collaborative group.
• Identify, recruit and support participating sites.
• Provide regular feedback on the progress of the trial and encourage sites to meet recruitment targets.
• Plan and organise mailshots, newsletters and collaborators’ or investigator meetings.
• Responsible for ensuring that the collection of data during the course of the trial is conducted so as to provide a complete, accurate and up to date trial data set(s) for analysis according to agreed deadlines.
• Train and supervise other staff (internal and external) involved in data management in the rules and procedures to be used, explaining the reasons/ principles behind them.
• Enter data onto the computer databases and perform regular systematic checks of information held on the trial database(s).

• Knowledge of the protected characteristics and duties under the Equality Act 2010. Including fostering good relations and advancing the universities Public Sector Equality Duty (PSED).
• Other relevant criteria from our equality and diversity knowledge, skills and experience document.
• Further particulars can be found here
• Further particulars can be found
• Higher degree in a relevant biomedical or associated subject, or degree (or equivalent) with practical experience in clinical research relevant to research or teaching area.
• In depth understanding of clinical research and trial management methodology and proven ability to apply these to the development, testing and implementation of trial management procedures.
• Office management and clerical skills that include excellent word processing & document layout.
• Experience and understanding of techniques for the management of medical research information. For example, data coding, entry validation and reporting, automating procedures.
• Experience in the design, maintenance and interrogation of complex relational databases.
• Experience of using statistics packages (e.g. SPSS, SAD) to perform statistical tests to analyse and manage trial data.
• Proven administrative and project management skills.
• Ability to work on own initiative and solve problems.
• Ability under management guidance to decide how to organise the work of a team, for example, Trial Administrator and Data Analyst.
• Effective communication, negotiation, presentation and interpersonal skills.
• Critical and intelligent attention to detail and high standard of accuracy.
• Ability to meet the travel needs of the post.
• equality and diversity knowledge, skills and experience document
• Informal enquiries to Helen Evans, email: h.e.evans.20@bham.ac.uk

• 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.
• 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.
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• benefits of working for the University of Birmingham