Job overview
We are recruiting for a Clinical Trials Monitor who shares our vision to be trusted to provide consistently outstanding care and exemplary service to our patients.
The Clinical Trials Monitor is a member of the GCP and regulatory compliance function, sitting within the Research & Development Core Services. The role is responsible for the conduct of monitoring for single and multicentre clinical trials (non-CTIMPS, CTIMPS and / or regulated medical devices) sponsored and/or hosted by East and North Hertfordshire Teaching NHS Trust, from initiation to close-out, in compliance with the UK Clinical Trials Regulations. The role develops and maintains close working relationships with the clinical trial management team, and the research delivery teams.
In addition, you will receive a High-Cost Area Supplement of 15% of your basic salary, subject to a minimum payment of £4,870 and a maximum payment of £6,137 per annum.
At the heart of everything we do are our core values: Include, Respect, and Improve. We encourage you to embrace these values throughout the recruitment process and in your role with us.
Main duties of the job
Undertake monitoring visits in line with clinical trial monitoring plan.
Prepare and disseminate monitoring reports, ensuring that issues are identified, recorded, and resolved.
To ensure correct conduct of clinical trials in accordance with the trial protocol, relevant Standard Operating Procedures (SOPs), GCP and regulatory requirements.
Contribute to ensuring that, as far as possible, East and North Hertfordshire Teaching NHS Trust remains ‘inspection ready’. Take a role in preparing for statutory MHRA Inspections and will work towards positioning us as a leader in quality/compliance in cancer research.
Act as an expert for East and North Hertfordshire Teaching NHS Trust for information and advice regarding clinical trials monitoring, recommending system changes and development, and sitting on relevant committees.
Working for our organisation
At East and North Hertfordshire Teaching NHS Trust, we are proud of the range of general and specialist services we provide and our 6,000 or so dedicated staff ensure our patients get the best care. Our ability to be flexible and innovative in the way in which we work and deliver our services to our catchment has never been more important than it is now.
We run the following hospitals:
* The Lister Hospital, Stevenage
* New Queen Elizabeth II (New QEII), Welwyn Garden City
* Hertford County, Hertford
* Mount Vernon Cancer Centre (MVCC), Northwood
We have ambitious plans to become an outstanding, patient-led Trust where dedicated staff provide high-quality, compassionate care to our patients. We continue to undergo significant transformation and our staff and patients are at the heart of delivering this ambitious agenda.
We are committed to a positive work life balance for our employees. This means that any employee is entitled to seek to work flexible working patterns and we are committed to listen and consider all requests. Such requests, of course, have to be made and considered formally, and will need to be balanced against service needs, but our starting point will always be to find ways to support making them happen.
Detailed job description and main responsibilities
Please see the attached Job Description and Person Specification applicant pack for further detailed information regarding this role.
Person specification
Qualifications / Training
Essential criteria
* Degree qualification (e.g., BSc) in a relevant subject or equivalent experience
* Recognised Good Clinical Practice (GCP) certification
* Commitment to continued professional development
Desirable criteria
* Higher degree qualification (e.g., MSc) in a relevant subject
Previous Experience
Essential criteria
* Prior experience of working as a clinical trial monitor (either in the academic or commercial sector)
* Experience of working to the UK Clinical Trials Regulations.
* Experience of working in an NHS or HEI environment in a clinical research environment.
* Experience of working with staff from a range of backgrounds and different levels of seniority.
Skills
Essential criteria
* Proven ability to develop effective working relationships with staff at all levels.
* Able to work in a proactive manner to identify new risks and issues and flag upwards appropriately.
* Ability to develop new administrative systems to improve efficiency.
* Able to work in a proactive manner to identify new risks and issues and flag upwards appropriately.
Knowledge
Essential criteria
* Detailed knowledge of UK Clinical Trials Regulations and GCP
* Able to summarise and explain complex issues to both technical and non-technical audiences
* Proficient IT literacy: evidence of competence with MS Office, particularly Excel, Word, PowerPoint, Teams, and Access.
Other Requirements
Essential criteria
* Understanding of, and commitment to, equality, diversity and inclusion
* Role model our Trust values every day