Senior Trial Coordinator - Cancer Clinical Trials UnitGrade 7
Senior Trial Coordinator - Cancer Clinical Trials UnitGrade 7
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£ 36130 - 45413
1 Vacancy
Job Description
Position Details
Cancer 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 36130 to 45413 with potential progression once in post to 48149
Grade: 7
Full Time Fixed Term contract up to September 2026
Closing date: 22nd June 2025
UK and International travel may be required for this role.
Open House Drop In Session:We will be holding an open house drop in session at the Universitys Exchange building in Centenary Square Birmingham between 10am and 5pm on Friday 6th June 2025. If youre interested in working at the University of Birmingham and perhaps have a few questions this is an opportunity to meet colleagues in the Recruitment team. It will be a relaxed and informal event you can drop in at any time.
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 sector-leading Birmingham Professional programmewhichprovides allprofessionalservices staff with development opportunities and the encouragement to reach their full almost 5000professionalservices jobs in a wide-range 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 state-of-the-art 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
Role Summary
This is a very varied and demanding post with considerable responsibility. Senior Trial Coordinators are responsible for managing a portfolio of trials and the staff working on those projects in addition to actively coordinating trials. They are expected to contribute to the design conduct analysis publication and presentation of clinical trials research. They must be able to use their own initiative be an effective leader team player and excellent communicator. They will usually take on a role which carries a national profile and as such they play a pivotal role in promoting the research activity of the CRCTU and developing its external collaborative network and establishing funding contacts.
The successful candidate will be responsible for managing a portfolio of trials and the staff working on those projects in addition to actively coordinating trials. They will need to ensure that the trials within their portfolio are conducted in accordance with Good Clinical Practice and applicable ethical regulatory and quality standards. The successful candidate will be expected to contribute to the design conduct analysis publication and presentation of clinical trials research.
Main Duties
- Expected to play a fundamental role in the design and preparation of new clinical trial research proposals and make a personal contribution to the CRCTUs research activity and profile. This will include preparation of costings and grant applications writing and editing the protocol design of case report forms and databases used to collect research data.
- Keep up to date with current research literature and developments in the disease site speciality and Trial Management profession. Maintain relevant bibliographies by regular literature searches and critical review. Bring ideas for innovative trials to the attention of the teams Clinical Lead. Write literature reviews develop and publish innovative approaches to improving trial methodology.
- Prepare appropriate interim publications (e.g. meeting abstracts) to maintain the research profile of the trial and play a pivotal role in the preparation and timely completion of final research publications.
- Keep up to date with changes in trial methodology regulatory issues and new develop strategies for their implementation at team level and also national level if appropriate to the trial. Help ensure that new skills knowledge and best practice are disseminated internally and externally to study sites if appropriate. This will involve contributing to the quality assurance programme (i.e. by writing / approving / implementing Trials Unit Standard Operating Procedures).
- Personally manage selected trials taking a lead in preparing and organising meetings reports and other activities of high importance complexity and sensitivity that require specialist knowledge or will generally include setting-up new trials negotiation with key external bodies overseeing the setting-up and monitoring of clinical sites and ensuring trials are run in accordance with current legislation.
- Take primary responsibility for ensuring that trial research data is complete and accurate. Work closely with members of the statistical team to validate the data set.
- Responsible for management of junior staff with respect to day-to-day supervision motivation and support of the staff (including work allocation cover rotas problem solving staff development and monitoring performance). Advise and assist in the appointment and training of the junior trial management staff. Mentor coach and guide other members of the team as necessary.
- Obtain appropriate regulatory and ethical approval for individual clinical trials. Ensure Standard Operating Procedures for safe conduct of trial are followed (e.g. reporting of adverse events to regulatory authorities and Data Monitoring Committee).
- Prepare trial progress reports as required by the regulatory authorities ethics committees trial Steering and Data Monitoring Committees funding bodies and external collaborators.
- Provide first point of contact for day-today queries from study sites regarding compliance with the teams portfolio of research protocols and provide cover for other Trial Coordinators.
- Promotion of the teams portfolio by the preparation of newsletters posters and by presenting at local national and occasionally international scientific meetings.
- Be able to use own initiative to solve research and staffing problems.
- Prepare standard operating procedures for the running of individual clinical trials to ensure that the research complies with current legislation.
- Initiate and oversee the design coding and testing of the research databases.
- Set up clinical sites and ensure that participating staff at these sites understand and are able to comply with the protocol and Good Clinical Practice and ensure that appropriate audit trails are being maintained in line with current legislation.
- Monitor progress of each centre 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 clinical sites i.e. which affect recruitment protocol adherence or patient safety. Conduct problem solving / quality assurance monitoring visits as required.
- Interpret statistical data.
- Act as a member of one or more trial management groups responsible for the management and organisation of the conduct of clinical trial protocols and administration of the clinical collaborative groups.
- Coordinate and support the activities of the Trial Management Group Steering Committee Data Monitoring Committee and the larger collaborative group.
- Plan expenditure against own trial budgets and negotiate with suppliers.
- Organise and coordinate the national meetings including preparation of an appropriate agenda obtaining sponsorship etc.
- Lecture on relevant courses and supervise students as required.
- Make an active contribution to setting maintaining and communicating CRCTU policy quality standards and trial management frameworks to junior members of staff.
- 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
- A higher degree (PhD or MSc) in a relevant biomedical science or associated subject with experience of clinical trials research (for some roles a proven track record of successfully obtaining research funding from a recognised funding body will suffice) or a graduate with strong experience as a Trial Coordinator and a proven ability to taken on a senior role
- An in-depth understanding of clinical research and trial management methodology including applicable regulatory requirements and a proven ability to apply these to the coordination of clinical trials
- Experience preparing regulatory and ethics submissions grant applications writing and/or amending protocols patient information sheets Case Report Forms reports and other relevant trial management documentation
- Proven project management and supervisory skills
- Excellent administrative clerical and office management skills
- Effective communication negotiation presentation and inter-personal skills
- Excellent computing skills including advanced word processing and email. Experience in the design maintenance and interrogation of complex relational databases (MS Access preferred)
- Able to work on own initiative and problem solve
- Must demonstrate a critical and intelligent attention to detail and high standards of accuracy
- Experience preparing publications and submitting grant applications is desirable
- Ability to meet the travel needs of the post which include travel nationally and internationally 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.
Further particulars can be foundhere
Informal enquiries to Charlotte Chapman 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:
Senior IC
Employment Type
Full-Time
