Clinical Trials Officer

1 week ago

Cambridge, Cambridgeshire, United Kingdom Cambridge University Hospital NHS Foundation Trust Full time

This post is part of the Cambridge Clinical Trials Unit (CCTU) atCambridge University Hospitals NHS Foundation Trust. TheCCTU caters for all investigators of Cambridge University Health Partners (CUHP), and has responsibility for new and existing Cambridge sponsored Clinical Trials of Investigational Medicinal Products under the EU Directive (CTIMPs) and other clinical research projects on the CCTU portfolio. The Trust currently acts as sponsor for approximately 50 CTIMPs. The post holder is part of the Quality Assurance team and the Clinical Trials Officer provides expert support for the review and set up of these clinical trials as well as the ongoing management to ensure they are conducted in compliance with Clinical Trial Regulations.

Main duties of the job The key job functions of the Clinical Trials Officer are:
  • To support the CCTU to manage and administer Sponsorshipresponsibilities for all CTIMPs.
  • To act as the liaison and main point of contact between theCCTU and the Trust/University regarding the management of sponsored CTIMPS.
  • To act as a point of contact for researchers, offering guidance and support to all stakeholders so that clinical trials are managed and conducted in line with SOPs, legal and regulatory requirements.
  • To support researchers and research teams in the set-up of CTIMPs and preparing submissions to the regulatory agencies (MHRA, REC and Trust R& D).
About us Our Trust

Cambridge University Hospitals (CUH) NHS Foundation Trust comprises Addenbrooke's Hospital and the Rosie Hospital in Cambridge. With over 12000 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 16th June 2024.

Interviews are due to be held on the 2nd July 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
  • Science Degree level or equivalent level of knowledge.
  • Current ICH GCP Training.
Desirable
  • Evidence of post-graduate training in relevant research field.
Experience Essential
  • Significant and demonstrable experience of working in a Sponsored CTIMP central project management/coordination role in a commercial or NHS environment.
  • CTIMP Regulatory documentation generation and submission experience, especially initial submissions.
Desirable
  • Demonstrable experience of CTIMP essential documentation generation.
  • Previous experience of CTIMP Risk Assessment processes.
Knowledge Essential
  • Extensive knowledge of the requirements of CTIMPs during their life-cycle, especially at the start-up stage.
  • Knowledge of regulatory requirements for Sponsors for CTIMPs.
  • CTIMP terminology, methodology and documentation.
  • Knowledge of the clinical trials regulatory framework.
Desirable
  • An understanding of the research process in the NHS.
Skills Essential
  • Excellent administrative skills including organising and planning. Excellent attention to details. Excellent communication, interpersonal, professional and motivational skills with the ability to build working relationships with internal and external departmental 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. Excellent IT skills
  • Excellent attention to detail.
  • Excellent communication, interpersonal, professional and motivational skills with the ability to build working relationships with internal and external departmental 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.
  • Excellent IT skills.
Desirable
  • Problem solver.
  • Focused, starter-finisher.
  • Willing to coach and train others.
Additional Requerments Essential
  • The ability to understand and behave at all times towards patients, visitors and colleagues according to the Trust values of safe, kind, excellent.
  • Can demonstrate autonomous working practices in current post.
Desirable
  • Flexible approach to working and a desire to develop knowledge and career.
Employer details Employer name Cambridge University Hospital NHS Foundation Trust Address Addenbrookes Hospitals-Division R& D

Hills Road

Cambridge

CB2 0QQ Any attachments will be accessible after you click to apply. 180-RD-245218#J-18808-Ljbffr

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