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Clinical Trials Monitor
3 months ago
**Main area**
- Research & Development**Grade**
- Band 6**Contract**
- 2 years (Fixed Term/Secondment for 2 years)**Hours**
- Full time - 37.5 hours per week (Will require some office based working)**Job ref**
- 180-RD-245192**Employer**
- Cambridge University Hospitals NHS Foundation Trust**Employer type**
- NHS**Site**
- Addenbrookes Hospital-Division R&D**Town**
- Cambridge**Salary**
- £35,392 - £42,618 p.a. pro rata**Salary period**
- Yearly**Closing**
- 27/05/2024 23:59**Interview date**
- 12/06/2024Job overview
Applications are invited for the post of Clinical Trials Monitor at the Cambridge Clinical Trials Unit (CCTU), which provides support for clinical trials within the Cambridge Biomedical Research Centre.
You will have responsibility for the essential monitoring of non-commercial clinical trials sponsored by Cambridge University Hospitals NHS Foundation Trust to ensure compliance in accordance with Good Clinical Practice (GCP) Guidelines, the Research Governance Framework for Health & Social Care (2005) and the Medicines for human Use (Clinical Trials) Regulations 2004.
You will also ensure that the rights of patients involved in research are protected in accordance with the Data Protection Act, Human Rights legislation and GCP.
You will work with colleagues in the Cambridge Clinical Trials Unit (CCTU) to support monitoring provision of Trust Sponsored Clinical Trials, and support for clinical researchers, under the guidance of a Senior Clinical Trial Monitor.
The monitor will be required to travel and stay overnight periodically in line with the requirements of the trials.
Main duties of the job
Developing clinical trials monitoring plans based upon the clinical trial Risk Assessment and an understanding of the key trial documentation for all trials as required.
Responsible for monitoring the conduct, documentation and progress of each clinical trial by performing risk based monitoring in accordance with the trial Monitoring Plan.
Complete written monitoring visit reports on the progress, management and conduct of clinical trial undertaken at the Trust.
Maintain participating site oversight by reviewing remote monitoring in accordance with CCTU SOPs and controlled documents.
Perform on-site monitoring visits as deemed necessary by the trial Risk Assessment and monitoring plan.
Participate in the development and management of systems including Standard Operating Procedures, R&D Policies and Procedures for CTIMPs sponsored by the Trust.
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 27th May 2024.
Interviews are due to be held on the 12th June 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 or equivalent experience.
- Evidence of ICH-GCP training.Desirable criteria
Monitoring Training.
- Evidence of GCLP training.Experience
Essential criteria
- Demonstrable experience of central coordination, monitoring or project managing clinical trials in an NHS Trust, University or pharmaceutical company.Desirable criteria
Direct experience of monitoring CTIMPs including laboratories and vendors.
- Experience of central data monitoring processes and outputs..Knowledge
Essential criteria
A sound working knowledge of GCP, the EU-directives and UK regulations on clinical trials.
Knowledge of CTIMP monitoring processes and requirements.
- Knowledge of CTIMP Risk Assessment processes and consideration.Desirable criteria
Demonstrate an understanding of the NHS research environment
Proven knowledg
