Job summary
Royal Papworth Hospital is the UK's leading heart and lung hospital and an internationally renowned centre offering specialist care for patients with cardio-respiratory conditions.
An exciting opportunity to work as a Clinical Trial Monitor (QA) has arisen within the Papworth Trials Unit Collaboration (PTUC). PTUC is a fully accredited Clinical Trials Unit and sits within the Research and Development department of Royal Papworth Hospital. We are a team of experienced and dedicated professionals working with our talented multi-disciplinary clinical teams to deliver a wide range of innovative high quality research trials to inform the future care of our patients.
This post will be based at the Heart and Lung Research Institute (HLRI) on the Cambridge Biomedical Campus. The HLRI is adjacent to Royal Papworth Hospital where meetings will also take place.
For an informal discussion regarding the post contact Quality Assurance Manager, Fiona Bottrill on 01223 639847
Main duties of the job
The main duties of this post include liaison with the study sponsor & Principal Investigators at other NHS centres & clinical teams, conducting monitoring & audit. The post will also include development of monitoring plans, co-ordinating central & site monitoring of studies, review of information & forward reporting/escalation, as well a management of staff within the QA team. The role will be involved in supporting the QA Manager with the implementation of Q-Pulse as a quality management system to be used within R&D.
The Trial Monitor works effectively as a research team member, ensuring achievement of monitoring /audit project deadlines, as well as regularly scheduling & attending meetings.
Experience of clinical research methodology, research governance framework as well as experience of existing UK clinical research structures, regulatory & ethical systems are essential. High level communication skills, project management experience & evidence of substantial problem solving & team working skills are also essential, as are computer literacy & reporting using database information.
Previous experience of monitoring & audit of clinical research, & experience of overseeing the monitoring of a large number of clinical trials with remote & on-site monitoring are desirable. A willingness to travel within the UK is essential.
About us
Royal Papworth Hospital NHS Foundation Trust is the UK's leading heart and lung hospital, delivering care to more than 50,000 patients a year in its new state-of-the-art hospital in Cambridge. We perform the most heart and/or lung transplants in the UK and carried out the UK's first successful heart transplant in 1979. It also offers emergency heart attack treatment, sleep centre care and is one of just five centres nationally for those in severe respiratory failure.
Based on the Cambridge Biomedical Campus the largest centre of medical research and health science in Europe the Trust is at the heart of treatments of the future. Royal Papworth became the first hospital trust in the country to be rated outstanding in all five areas assessed by the Care Quality Commission - a rating it still holds today. The Trust holds its values of compassion, excellence & collaboration at its core, and all colleagues joining the team are expected to uphold these in their day-to-day roles & interactions. Royal Papworth is proud of its diverse workforce and encourages people to embrace their individuality.
The Trust values difference and welcomes all applications irrespective of age, disability, gender reassignment, marriage and civil partnership, pregnancy & maternity, race, religion & belief, sex and sexual orientation. Providing they meet the minimum post criteria, applicants with disabilities will be offered an interview.
For a street view tour: https://royalpapworth.nhs.uk/virtual-tour
Job description
Job responsibilities
On this page you will find a Role Profile which provides information about the hospital and full details about the role. We recommend that you review this and refer to it as you complete your application. Please include how you will meet the Trust Values Compassion, Excellence and Collaboration. If you would like more information about the role or working at Royal Papworth Hospital, please get in touch with the contact for this role.
Job description
Job responsibilities
On this page you will find a Role Profile which provides information about the hospital and full details about the role. We recommend that you review this and refer to it as you complete your application. Please include how you will meet the Trust Values Compassion, Excellence and Collaboration. If you would like more information about the role or working at Royal Papworth Hospital, please get in touch with the contact for this role.
Person Specification
Qualifications
Essential
- Degree in a science/healthcare subject or experience in working in clinical trials
Experience
Essential
- Experience and sound working knowledge of Q-pulse
- Experience of working in clinical trials either as a trial co-ordinator/manager or as a Trial Monitor
- Excellent understanding all regulatory and ethical systems governing clinical research, including but not limited to:
- *The principles of ICH GCP
- *The Medicines for Human Use
- (Clinical Trials) Regulations
- 2004 and all amendments
- *Research Governance Framework
- for Health and Community Care
- *Mental Capacity Act
- *Human Tissue Act
- *Data Protection Act
- Experience of undertaking and proven ability in coordinating projects.
- Proficient in the use of Microsoft product word, excel, Access & Powerpoint.
- Understand importance of accurate data collection and recording for clinical use.
- Previous experience of using a Clinical Trial database system (electronic CRF), including knowledge of randomisation.
- Extensive understanding and knowledge of improving and maintaining Data Quality
- Clinical Research knowledge or experience
- High attention to detail and accuracy
- Excellent communication skills both written and verbal
- Experience of working with multi-disciplinary teams
- Excellent organisational & Administrative skills
- Positive attitude to change
- Maintains the quality in own work with an emphasis on attention to detail
- Teamwork and Motivation
- Can demonstrate the ability to delegate work to others and/or help to build co-operation to deliver team results.
- Liaison and Networking
- Can demonstrate the ability to work across sites to build and strengthen working relationships. Actively pursues a shared interest and works jointly to influence events and decisions.
- Initiative and Problem Solving
- Can demonstrate the ability to investigate problems to identify their cause, takes action to prevent recurrence of problems and considers possible solutions to identify those which offer wider benefits
- Decision Making
- Can demonstrate the ability to consider the impact on the Faculty/Service. Knows where a decision is beyond their responsibility and refers to others.
- Planning and Organisation
- Can demonstrate the ability to ensure that the work is carried out effectively and that resources are available to meet demand. Identifies the need for further action and resources by monitoring progress.
- Prioritisation
- Can demonstrate ability and experience in the need to prioritise and re-organise work load at short notice, while maintaining delivery of trial requirements
Desirable
- Previous experience as a Trial Monitor.
- Evidence of preparing regulatory and ethics submissions, writing/amending protocols, PIS, CRFs and other relevant trial management documentation
- Previous experience of working with an electronic database for monitoring and resolution of monitoring queries and discrepancies
- Experience of line management
- Attendance of a recognised research monitoring/auditing research course
- Understanding of a clinical/hospital environment (D)
Additional Criteria
Essential
- Please provide evidence of your commitment to uphold the Trust's values: Compassion, Excellence, Collaboration
Person Specification
Qualifications
Essential
- Degree in a science/healthcare subject or experience in working in clinical trials
Experience
Essential
- Experience and sound working knowledge of Q-pulse
- Experience of working in clinical trials either as a trial co-ordinator/manager or as a Trial Monitor
- Excellent understanding all regulatory and ethical systems governing clinical research, including but not limited to:
- *The principles of ICH GCP
- *The Medicines for Human Use
- (Clinical Trials) Regulations
- 2004 and all amendments
- *Research Governance Framework
- for Health and Community Care
- *Mental Capacity Act
- *Human Tissue Act
- *Data Protection Act
- Experience of undertaking and proven ability in coordinating projects.
- Proficient in the use of Microsoft product word, excel, Access & Powerpoint.
- Understand importance of accurate data collection and recording for clinical use.
- Previous experience of using a Clinical Trial database system (electronic CRF), including knowledge of randomisation.
- Extensive understanding and knowledge of improving and maintaining Data Quality
- Clinical Research knowledge or experience
- High attention to detail and accuracy
- Excellent communication skills both written and verbal
- Experience of working with multi-disciplinary teams
- Excellent organisational & Administrative skills
- Positive attitude to change
- Maintains the quality in own work with an emphasis on attention to detail
- Teamwork and Motivation
- Can demonstrate the ability to delegate work to others and/or help to build co-operation to deliver team results.
- Liaison and Networking
- Can demonstrate the ability to work across sites to build and strengthen working relationships. Actively pursues a shared interest and works jointly to influence events and decisions.
- Initiative and Problem Solving
- Can demonstrate the ability to investigate problems to identify their cause, takes action to prevent recurrence of problems and considers possible solutions to identify those which offer wider benefits
- Decision Making
- Can demonstrate the ability to consider the impact on the Faculty/Service. Knows where a decision is beyond their responsibility and refers to others.
- Planning and Organisation
- Can demonstrate the ability to ensure that the work is carried out effectively and that resources are available to meet demand. Identifies the need for further action and resources by monitoring progress.
- Prioritisation
- Can demonstrate ability and experience in the need to prioritise and re-organise work load at short notice, while maintaining delivery of trial requirements
Desirable
- Previous experience as a Trial Monitor.
- Evidence of preparing regulatory and ethics submissions, writing/amending protocols, PIS, CRFs and other relevant trial management documentation
- Previous experience of working with an electronic database for monitoring and resolution of monitoring queries and discrepancies
- Experience of line management
- Attendance of a recognised research monitoring/auditing research course
- Understanding of a clinical/hospital environment (D)
Additional Criteria
Essential
- Please provide evidence of your commitment to uphold the Trust's values: Compassion, Excellence, Collaboration
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.
