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    Clinical Trial Coordinator - Cambridge, United Kingdom - Cambridge University Hospital NHS Foundation Trust

    Cambridge University Hospital NHS Foundation Trust
    Cambridge University Hospital NHS Foundation Trust Cambridge, United Kingdom

    2 weeks ago

    Default job background
    Fixed-Term
    Description

    Job summary

    We are looking for a Clinical Trial Coordinator to be part of the well-established Cancer Theme of the Cambridge Clinical Trials Unit. This is a non-patient facing position, requiring a candidate with clinical trials and/or project management experience.

    You will have primary responsibility for coordinating a multicentre clinical trial of an investigational medicinal product (CTIMP) in the urological malignancies field.

    Your day to day job will involve working closely with data managers, laboratory staff, statisticians and programmers, but also to liaise with medical staff involved in oncology trials and monitor the conduct of the studies. You will interact with regulatory authorities and collaborators, produce reports to stakeholders, and work in accordance with nationally agreed standards. This post is funded for 1 year, in the first instance, with the potential for contract renewal, dependent upon funding.

    The job is a hybrid role, involving mandatory office presence in Cambridge of at least 1 day a week. Interviews are expected to take place w/c 8th January 2024 and will be face-to-face in Cambridge.

    Main duties of the job

    Coordinate the setup and conduct of clinical trials and/or clinical studies working closely with the chief investigators and their teams.

    Setup participating sites in multi-centre trials and ensuring that all data and samples are collected following the protocol.

    To work in compliance with the International Conference on Harmonisation Good Clinical Practice Guidelines (ICH-GCP), the NHS Research Governance Framework for Health & Social Care and, in the case of a CTIMP, in compliance with the Medicines for Human Use (Clinical Trials) Regulations 2004.

    About us

    Our Trust

    Cambridge University Hospitals (CUH) NHS Foundation Trust comprises Addenbrooke's Hospital and the Rosie Hospital in Cambridge. With over 11000 staff and over 1100 beds the priorities of the Trust focus on a quality service which is all about people - patients, staff and partners. Recognised as providing 'outstanding' care to our patients and rated 'Good' overall by the Care Quality Commissioner, is testament to the skill and dedication of the people who work here. CUH's values - Together - Safe, Kind, Excellent - are at the heart of patient care, defining the way all staff work and behave. The Trust provides accessible high-quality healthcare for the local people of Cambridge, together with specialist services, dealing with rare or complex conditions for a regional, national and international population.

    CUH is committed to promoting a diverse and inclusive community - a place where we can all be ourselves. We value our differences and fully advocate and support an inclusive working environment where every individual can fulfil their potential. We want to ensure our people are truly representative of all the communities that we serve. We welcome applications for all positions in the organisation irrespective of people's age, disability, ethnicity, race, nationality, gender identity, sex, sexual orientation, religion or belief, marriage and civil partnership status, or pregnancy and maternity status or social economic background.

    Job description

    Job responsibilities

    Please see the attached Applicant Information Pack (combined Job Description and Person Specification) for key duties and responsibilities.

    This vacancy will close at midnight on the 15th May 2024.

    Interviews are due to be held on the 28th May 2024.

    Benefits to you

    We offer development opportunities and a wide range of benefits including on-site leisure facilities, shopping concourse, day nurseries and access to a great transport system with easy access to airports and rail travel.

    Please note if you would like to discuss the required hours of this role further, you should approach the contact given. In some cases alternative working hours will be considered.

    We welcome applications from the Armed Forces.

    Person Specification

    Qualifications

    Essential

  • Educated to Degree level in health-related or biomedical science or with equivalent experience.

    • Desirable

  • Evidence of post-graduate training in relevant field, and/or continuous professional development in relevant fields.

    • Experience

    Essential

  • Significant experience of working in clinical research, including observational studies and Clinical Trials falling under the EU Directive of Clinical Trials within the NHS and/or University.
  • Substantial experience in the set-up, protocol development, coordination and management of clinical trials REC, MHRA, R&D submissions and report writing Grant applications & grant costing Setting timelines and milestones.
  • Experience of line management.
  • Experience in managing a portfolio of trials.

    • Desirable

  • Experience of monitoring.
  • Experience of document review.
  • Experience of MHRA GCP Inspections and/or Sponsor Audits.
  • Experience of leading meetings and informing best practices.
  • Experience of developing new procedures and generating supporting SOPs.
  • Experience of collaborating with the pharmaceutical industry in a clinical trial setting.

    • Knowledge

    Essential

  • Significant knowledge of UK regulations, guidelines and requirements for the conduct of clinical research.
  • Good understanding of specific requirements for clinical trials, NHS research governance and NHS/UK approval processes.
  • Knowledge of study and protocol design, case report form and database design, and pharmacovigilance requirements.
  • Knowledge of data protection requirements

    • Desirable

  • Knowledge of Human Tissue act.
  • Knowledge of Advanced Therapy Trials IMP(GMP) and QP release.

    • Skills

    Essential

  • Excellent administrative skills including organising and planning.
  • Excellent communication skills.
  • Excellent attention to detail.
  • Helpful, outgoing team worker.
  • Excellent interpersonal, professional and motivational skills with the ability to build working relationships with internal and external department and Trust colleagues.
  • Ability to work under pressure, prioritise and seek input where necessary.
  • Ability to work independently with initiative and motivate self and others.
  • Ability to maintain confidentiality
  • Ability to negotiate, acting in a tactful and confident manner to achieve the desired results.

    • Desirable

  • Problem solver.
  • Focused, starter-finisher.
  • Willing to coach and train others.

    • Additional Requirements

    Essential

  • The ability to understand and behave at all times, towards patients, visitors and colleagues according to the Trust values of safe, kind, excellent.
  • Flexible approach to working and a desire to develop knowledge and career.
  • Can demonstrate autonomous working practices in current post.
  • Ability to travel to participating sites to conduct on-site visits.
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