Job summary
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.
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 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.
We welcome applications from the Armed Forces.
Person Specification
Qualifications
Essential
- Science Degree or equivalent experience.
- Evidence of ICH-GCP training.
Desirable
- Monitoring Training.
- Evidence of GCLP training.
Experience
Essential
- Demonstrable experience of central coordination, monitoring or project managing clinical trials in an NHS Trust, University or pharmaceutical company.
Desirable
- Experience of applying for regulatory/research approvals or handling research applications.
- Direct experience of monitoring CTIMPs including laboratories and vendors.
- Experience of central data monitoring processes and outputs..
Knowledge
Essential
- 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
- Demonstrate an understanding of the NHS research environment
- Proven knowledge of Ethics, HRA, MHRA and R&D approval processes.
- Laboratory oversight and sample handling knowledge, particularly GCP for Labs.
- Knowledge of pharmacovigilance requirements for CTIMPs.
Skills
Essential
- Ability to write and work to Standard Operating Procedures.
- Good IT skills (including the use of databases, Word, Excel, email and the Internet).
- Excellent communication skills with proven ability to work effectively as part of a team.
- Ability to work independently with minimal day to day supervision, make decisions and delegate work appropriately.
- Time management skills and the ability to prioritise workload and work under pressure.
- Good writing and presentation skills.
Desirable
- Ability to communicate with senior research staff and communicate sometimes difficult information.
Additional Requirements
Essential
- Current, full UK Driving Licence.
- The ability to understand and behave at all times, towards patients, visitors and colleagues according to the Trust values of Safe, Kind, Excellent.
- Able to travel and stay overnight periodically (no more than 3 times a month) in line with the job requirements.
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website .
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants .
Employer details
Employer name
Cambridge University Hospital NHS Foundation Trust
Address
Addenbrookes Hospital-Division R&D
Hills Road
Cambridge
CB2 0QQ