Job summary
Fixed term contract/ secondment opportunity for 2 years.
As the successful post holder, you will:
Work as part of the team responsible for research management and governance for clinical trials sponsored by NNUH or trials hosted in the Norfolk Clinical Research Facility (CRF).
Ensure that ensure that the clinical trials are conducted in compliance with the protocol, overall clinical objectives, ICH GCP and NNUH SOPs and are run according to agreed timelines.
Through monitoring and the provision of training, you will ensure that quality standards for research are met and maintained within all research active departments within the Trust.
Plan, co-ordinate and facilitate the monitoring of research trials as part of an ongoing monitoring program, producing reports and recommendations arising from monitoring for the Joint Research Governance Committee.
Full time 37.5 hours per week.
Advert closing: 4th June 2023
Interview date: 15th June 2023
If you are considering applying for this post on a secondment basis, please discuss with your Line Manager prior to applying to ascertain whether this could be supported.
Main duties of the job
This post offers an opportunity for a motivated individual to join our Research Governance Team working closely with the Research Governance Coordinator. Your key responsibilities will be:
- To facilitate the efficient setting up, monitoring, and closing down of clinical trials.
- To ensure correct conduct of clinical trials in accordance with the study protocol, relevant SOPs, and Good Clinical Practice (GCP).
- To perform Site Initiation Visits, sponsor oversight visits and study closeout visits as required.
- To write monitoring plans for clinical trials sponsored by NNUH.
- To perform Source Data Verification (SDV) of study data to check original source documents against what has been entered into the study database.
- Undertake a programme for research audit and monitoring for all research activity sponsored by the Trust or hosted in the Norfolk CRF. This will require working closely with the Research Governance Co-ordinator.
- Supporting the work of the Research Office in preparing for any inspection of the Trust's research activities.
There will be a possibility of Hybrid working with some flexibility over the working hours and training opportunities within the role.
About us
We can offer you the full range of NHS benefits/discounts and in addition:
- Flexible working hours
- Fast Track Staff Physiotherapy Service
- Multi Faith prayer room
- Discounted gym memberships
- Excellent pension scheme and annual leave entitlement
- Wagestream - access up to 40% of your pay as you earn it
- Free Park & Ride service direct to NNUH site
- Free 24-hours confidential counselling support
- On-site Nursery
- On-site cafes offering staff discounts
- Support in career development
- Flexible staff bank
- Salary Sacrifice schemes including lease cars, Cycle to Work scheme and home electronics
Job description
Job responsibilities
The following skills and experience will be required and are essential for the successful candidates:
- To facilitate the efficient setting up, monitoring, and closing down of clinical trials sponsored by NNUH as required.
- To ensure correct conduct of clinical trials in accordance with the study protocol, relevant SOPs, and Good Clinical Practice (GCP).
- To perform Site Initiation Visits, sponsor oversight visits and study closeout visits as required.
- To write monitoring plans for clinical trials sponsored by NNUH.
- To perform Source Data Verification (SDV) of study data to check original source documents against what has been entered into the study database
- Undertake a programme for research audit and monitoring for all research activity sponsored by the Trust or hosted in the Norfolk CRF. This will require working closely with the Research Governance Co-ordinator.
- Planning and co-ordinating research audit and monitoring in consultation with the Research Governance Co-ordinator. This will involve arranging meetings, consulting with researchers and their teams both internal and external and may require adjustment to suit the requirements of the parties involved and to meet appropriate timescales. It will include single and multicentre projects where external academic, or NHS organisations are involved. It will include liaison with staff across the research park and within Trust departments supporting research such as Pharmacy or Pathology.
Please refer to the Job Description for the full specification of responsibilities and requirements for this post.
Job description
Job responsibilities
The following skills and experience will be required and are essential for the successful candidates:
- To facilitate the efficient setting up, monitoring, and closing down of clinical trials sponsored by NNUH as required.
- To ensure correct conduct of clinical trials in accordance with the study protocol, relevant SOPs, and Good Clinical Practice (GCP).
- To perform Site Initiation Visits, sponsor oversight visits and study closeout visits as required.
- To write monitoring plans for clinical trials sponsored by NNUH.
- To perform Source Data Verification (SDV) of study data to check original source documents against what has been entered into the study database
- Undertake a programme for research audit and monitoring for all research activity sponsored by the Trust or hosted in the Norfolk CRF. This will require working closely with the Research Governance Co-ordinator.
- Planning and co-ordinating research audit and monitoring in consultation with the Research Governance Co-ordinator. This will involve arranging meetings, consulting with researchers and their teams both internal and external and may require adjustment to suit the requirements of the parties involved and to meet appropriate timescales. It will include single and multicentre projects where external academic, or NHS organisations are involved. It will include liaison with staff across the research park and within Trust departments supporting research such as Pharmacy or Pathology.
Please refer to the Job Description for the full specification of responsibilities and requirements for this post.
Person Specification
Qualifications
Essential
- Educated to first degree level or equivalent experience in a relevant discipline
- Knowledge of Good Clinical Practice (GCP) and relevant regulations
Experience
Essential
- Minimum of 2 years' experience of research in a healthcare setting or quality assurance
Skills
Essential
- Self-motivated with the ability to organise and plan
- Excellent communication and interpersonal skills
Attitude & Aptitude
Essential
- Effective role model, demonstrating NNUH's PRIDE values of People focussed, Respect, Integrity, Dedication and Excellence
- Demonstrates understanding and commitment to Equality, Diversity and Inclusion
Person Specification
Qualifications
Essential
- Educated to first degree level or equivalent experience in a relevant discipline
- Knowledge of Good Clinical Practice (GCP) and relevant regulations
Experience
Essential
- Minimum of 2 years' experience of research in a healthcare setting or quality assurance
Skills
Essential
- Self-motivated with the ability to organise and plan
- Excellent communication and interpersonal skills
Attitude & Aptitude
Essential
- Effective role model, demonstrating NNUH's PRIDE values of People focussed, Respect, Integrity, Dedication and Excellence
- Demonstrates understanding and commitment to Equality, Diversity and Inclusion
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 (Opens in a new tab).
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 (Opens in a new tab).
Additional information
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 (Opens in a new tab).
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 (Opens in a new tab).
