Trial Coordinator - Cancer Research UK Clinical Trials Unit - 54504Z25 - Grade 6
Trial Coordinator - Cancer Research UK Clinical Trials Unit - 54504Z25 - Grade 6
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£ 32546 - 35116
1 Vacancy
Job Description
Position Details
Cancer Research UK Clinical Trials Unit School of Medical Sciences College of Medicine and Health
Location: University of Birmingham Edgbaston Birmingham UK
Full time starting salary is normally in the range 32546 to 35116 with potential progression once in post to 39355
Grade: 6
Full Time Fixed Term contract up to April 2026
Closing date: 20th May 2025
This role is also open as an internal secondment opportunity which would need to be agreed by your current line manager.
Our offer to you
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 andweare equally proud to be recognised as a leading global 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 todevelopthrough our sectorleading Birmingham Professional programmewhichprovides allprofessionalservices staff with development opportunities and the encouragement to reach their full almost 5000professionalservices jobs in a widerange of functionsin Edgbaston andin our campus inDubai there are plenty of opportunities foryou to be able to develop yourcareer 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 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 areand how we work.
Supporting our people to achieve a healthy work/life balance is important both to our employees andtothe success of the University and depending on the role we offer avarietyof flexible working arrangements. We therefore welcome discussions on all forms of flexible addition you will receive a generous package of benefits including 40 dayspaid holidaya 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 campus we have a stateoftheart sports centre with pool shopsplaces to eat and drinkour own art gallery museum and botanical gardens.
Find out more about thebenefits of working for the Universityof Birmingham
Background
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 College of Medicine and Health andspecialises in running cancerclinical 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 noncancer 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.
The successful candidate will be responsible for the coordination of one or more clinical trials ensuring that the trials are conducted in accordance with good clinical practice and applicable ethical regulatory and quality standards. They will be involved in the development of trial documentation submission of regulatory and ethical applications the preparation and submission of pertinent reports managing participating sites and the collaborative group the supervision of junior staff and preparing the data for analysis/publication.
Applicants will preferably have a higher degree in a relevant biomedical or associated subject or be a graduate with equivalent experience. Previous trial management experience is preferred but on the job training will be provided for exceptional candidates. They must be able to use their own initiative and work effectively as part of a team. Excellent communication and organisational skills with a critical intelligent attention to detail are essential for this role.Experience using Microsoft Office applications is also essential while experience with Microsoft Access would be a distinct advantage. Applicants should be prepared to meet the travel requirements of the post which includes travel nationally.
Hybrid working is possible in line with both CRCTU and University of Birmingham policies.
Role Summary
The Trial Coordinator will be a member of one or more trial working groups responsible for the management and organisation of the trial(s) office for the conduct of large clinical trial protocols and administration of the clinical collaborative groups. They are expected to be capable of the continued development critical appraisal and documentation of appropriate procedures for managing trial protocols requires specialist expertise and experience and a good understanding of how the theories and concepts that underlie the design conduct and analysis of clinical trials are applied in practice. Trial Coordinators are expected to make an active contribution to setting maintaining and communicating CRCTU policy quality standards and trial management frameworks.
Main Duties
- 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 and ensure that staff at participating sites understand and are able to comply with the 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.
- Coordinators may contribute to the design analysis publication and presentation of the research. This may involve writing researching grant applications contributing to the design development and feasibility testing of protocols case report forms coding lists and databases. Writing abstracts designing posters and contributing to journal articles.
- 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. Maintain trial website.
- 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).Decide what steps need to be taken to correct any missing contradictory or incorrect data and ensure that these problems are followed through to a satisfactory conclusion within a reasonable timescale. Monitor for systematic or serious errors and inconsistencies breaking problems down to identify their cause in order to take action to improve working systems and prevent recurrence.
- Develop and document guidance notes and procedures for the conduct of the trial and ensure other members of staff are fully trained to understand and follow them. Create trial management tools including forms and databases.
- Prepare trial reports as required. For example progress reports required by unit management and the various trial steering and data monitoring committees funding bodies or sponsors. Maintain CRCTU Central Administrative Database.
- Coordinate and support the activities of the trial management group steering and data monitoring committees. Represent the CRCTUs interests and policies effectively at this level and report back to management.
- Key member of the trial management group contributing to the content type and frequency of the case report forms to collect the information required to answer the research questions reliably and efficiently. Designing case report forms etc to be as attractive and easy to use thus promoting error free data return. In discussion with clinical investigators decide the rules and procedures that will be used for coding interpretation entry and checking of the data.
- Record and code incoming forms and/or abstract from source records for data entry checking for inconsistencies violations and unusual or adverse events. Where necessary agree new or changed rules codes and procedures for the entry of nonroutine or ad hoc data with the trial management group. Maintain and circulate coding lists and inform other trial management staff of changes.
- Work with the trial statistician performing preliminary and routine data analysis.
- Contribute to the work of the trial management team supporting the team leader lead statistician and principal clinical investigators in the development and conduct of the team entire portfolio of research. Represent team on CRCTU committees e.g. web committee publicity committee etc.
- Contribute to the CRCTU Quality Management System.
- Keep up to date with current research literature and developments in both the professional field and the disease site speciality. Maintain relevant bibliographies by regular literature searches and critical review. Developing and publishing innovative approaches to improving trial methodology is encouraged.
- Present and give talks on the research (i.e. about the clinical trial and trial methodology) both internally and at major scientific / collaborators meetings. Coordinators may have some lecturing and teaching duties within the School and on the various clinical trial professional development courses.
- Perform other tasks pertinent to the role.
- Support the delivery of clinical research in accordance with Good Clinical Practice (GCP) the Declaration of Helsinki applicable legislation (including but not limited to the Medicines for Human Use Clinical Trials Regulations Data Protection Act 1998 Human Tissue Act) the Research Governance Framework for Health and Social Care Caldicott principals and applicable NHS Trust and University policies and procedures (including but not limited to the Universitys Data Protection Policy Information Security Policy and Code of Practice for Research) in order to protect the research subject and the quality of each study.
- Promotes equality and values diversity acting as a role model and fostering an inclusive working culture.
Required Knowledge Skills Qualifications Experience
- Higher degree in a relevant biomedical or associated subject or graduate with strong experience in clinical research.
- An 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 e.g. data coding entry validation and reporting. Ability to develop automated office procedures and to manage complex relational computer databases.
- Experience in the design maintenance and interrogation of complex relational databases (MS Access or SQL Server preferred).
- Experience of using statistics packages such as SPSS and SAS e.g. to perform appropriate statistical tests and procedures for routine analysis and management of the trial data.
- Proven administrative and project management skills. Able to work on own initiative and problem solve. Can take own decisions to organise the work of a professional team under management guidance.
- Effective communication negotiation presentation and interpersonal skills.
- Must demonstrate a critical and intelligent attention to detail and high standards of accuracy.
- Ability to meet the travel needs of the post which includes travel in the Birmingham area and further afield on occasion.
- Knowledge of the protected characteristics of the Equality Act 2010 and how to actively ensure in day to day activity in own area that those with protected characteristics are treated equally and fairly.
Promising candidates who lack the experience to coordinate a trial independently may be accepted for training.
Further particulars can be foundhere
Informal enquiries to Sophia Magwaro email:
View our staff values and behaviourshere
We 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 everyoneon our website.
Required Experience:
IC
Employment Type
Full-Time
