Clinical Trials Officer

4 weeks ago


Cambridge, United Kingdom Cambridge University Hospitals Full time

**Main area**
- Research and Development**Grade**
- Band 6**Contract**
- 24 months (Fixed Term for 24 months)**Hours**
- Full time
Part time
Flexible working

37.5 hours per week (Full Time or Part Time/Flexible working hours may be considered. Will require some office based working)**Job ref**
- 180-RD-245218**Employer**
- Cambridge University Hospitals NHS Foundation Trust**Employer type**
- NHS**Site**
- Addenbrookes Hospitals-Division R&D**Town**
- Cambridge**Salary**
- £35,392 - £42,618 p.a. pro rata**Salary period**
- Yearly**Closing**
- 16/06/2024 23:59**Interview date**
- 02/07/2024Job overview

This post is part of the Cambridge Clinical Trials Unit (CCTU) at Cambridge University Hospitals NHS Foundation Trust. The CCTU 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 Sponsorship
responsibilities for all CTIMPs.

To act as the liaison and main point of contact between the
CCTU 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).Working for our organisation

**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.

Detailed job description and main 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.

Person specification

**Qualifications**:
Essential criteria

Science Degree level or equivalent level of knowledge.
- Current ICH GCP Training.Desirable criteria
- Evidence of post-graduate training in relevant research field.Experience

Essential criteria

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 criteria

Demonstrable experience of CTIMP essential documentation generation.
- Previous experience of CTIMP Risk Assessment processes.Knowledge

Essential criteria

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 criteria
- An understanding of the research process in the NHS.**Skills**:
Essential criteria

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



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