• Job Description

  Req#: 3687

  Position Details

  Cancer Research (UK) Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences

  Location: University of Birmingham, Edgbaston, Birmingham UK

  Full time starting salary is normally in the range £34,980 to £44,263 with potential progression once in post to £46,974

  Grade: 7

  Full Time, Fixed Term contract up to January 2027

  Three positions available

  Closing date: 5th January 2024

  UK and international travel may be required for this role

  Hybrid working is possible in line with both CRCTU and University of Birmingham policies

  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, 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.

  We are committed to helping the people who work here to develop through our sector-leading Birmingham Professional programme which provides all professional services staff with development opportunities and the encouragement to reach their full potential. 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.

  Find out more about the benefits of working for the University of 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.

  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 CRCTU’s 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 team’s 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 legislation. Help 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 expertise. This 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 team’s portfolio of research protocols and provide cover for other Trial Coordinators.
  • Promotion of the team’s 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 University’s 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) or near to completion, 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

  Dimensions

  Staffing

  Senior Trial Coordinators act as first line managers to a small group of trial management staff including Trial Coordinators (academic-related grade 6), Trial Administrators (Support Grade 5) and/or Data Managers (Support Grade 4). They report to the Trial Management Team Leader.

  Financial

  Senior Trial Coordinators assist academic investigators in the costing, preparation and submission of research grant applications, providing specialist trial management advice and working under the guidance of the Trial Management Team Leader. They may be named as co-applicants on grant applications in their own right.

  Senior Trial Coordinators also monitor and approve expenditure on research grants, although the overall responsibility rests with the Trial Management Team Leader and the grant holder.

  Customer

  An important aspect of the post of Senior Trial Coordinator is to build relationships with a range of customers, typically including: professors, consultants, nurses, pharmacists, radiologists, pathologists and other medical professionals who may be members of one of the trial’s groups/committees or based at participating sites; other trials professionals e.g. statisticians, programmers, monitors; patients and patient representatives; the Sponsor representative; contracts officers; and suppliers.

  Senior Trial Coordinators can personally manage clinical trials (i.e. act as the project Trial Coordinator) as well as providing specialist advice and guidance on all clinical trials within their portfolio. As such they will come into contact with a large group of internal and external customers (>500).

  Operational

  Clinical trials are highly regulated and Senior Trial Coordinators play a pivotal role in ensuring compliance of their portfolio of trials with the regulations governing clinical trials, unit policy and procedure. Senior Trial Coordinators are expected to make an active contribution to the writing of, and training on, standard operating procedures for specific trial management related tasks. They identify issues with operational procedures and act as members of internal working groups to address operational issues. They are also expected to convey unit policy and procedure to both internal and external investigators.

  Senior Trial Coordinators represent the unit in a professional capacity at local, regional and national and international meetings and fund raising events.

  Planning and Organising

  Senior Trial Coordinators manage a small portfolio of research projects and/or clinical trials and the individuals working on those projects. They may personally coordinate trials.

  Responsibility for a particular project and member of staff will be allocated by the relevant Trial Management Team Leader. Trials are typically between 3 and 10 years duration. They follow a standard path through grant application, set-up, recruitment, follow up, analysis, closure and archiving, and the Senior Trial Coordinator’s role will vary according to the composition of the portfolio and the stage of their trial(s).

  Senior Trial Coordinators will need to plan and organise their own workload, and that of staff working on their portfolio of trials. The Senior Trial Coordinator will need to be reactive as problems (e.g. safety issues) and queries from sites and/or patients often arise with very short notice and quite frequently have to be dealt with immediately. Hence Senior Trial Coordinators have to be very organised and able to reprioritise their workload at a moment’s notice while still meeting regulatory deadlines.

  Problem Solving and decision making

  Senior Trial Coordinators must be able to work independently and are expected to deal with most day-to-day problems (e.g. regarding GCP compliance, non-clinical protocol queries, staffing issues) without reference to others. They must be able to use sound judgment in deciding when queries need to be forwarded onto a clinician (safety or treatment queries) or a more senior member of staff (e.g. serious staffing problems, potential serious breach of the protocol or GCP).

  They are expected to ensure staff follow the CRCTU’s quality management system and comply with the protocol, the ethical and regulatory approvals for the trial, GCP, research governance guidelines and applicable regulations.

  Internal and External relationships

  Funding Bodies

  Must be able to effectively communicate details of research proposal. Good negotiation skills are required.

  Professors & Consultants in Oncology

  Excellent communication, presentation and other medical personnel skills. Must be able to clearly explain scientific background, clinical, practical and financial aspects of research projects effectively.

  Patients

  Must be able to communicate with patients, answering queries in a way appropriate to their level of understanding. Will take responsibility for writing Patient Information Sheets which must be easy for the layperson to understand and comply with current ethical guidelines.

  Suppliers

  Be able to effectively negotiate with suppliers.

  Further particulars can be found here
  
  Informal enquiries to Sarah Bowden, email: S.J.Bowden@bham.ac.uk
  
  View our staff values and behaviours here

  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. You can find out more about our work to create a fairer university for everyone on our website .

• About the company

  The University of Birmingham is a public research university located in Edgbaston, Birmingham, United Kingdom.

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