Job summary
The post holder will be responsible for study set up and management of research studies to ensure adherence to Research Governance in accordance with national and international regulatory frameworks and NIHR RDN High Level Objectives including:(i) study set up and confirmation of capacity and capability: actively advising and guiding researchers of all professions on all stages of the research process.(ii) performance management of NIHR studies;(iii) contributing to the monitoring and audit procedures required of the Clinical Research & Innovation Office (CRIO) for Trust and University research studies across all sites of the STH.(iv) contributing to the Quality Assurance of Clinical Research & Innovation Office systems.(v) contributing to the Clinical Research & Innovation Office education programmes.(vi) contributing to the Clinical Research & Innovation Office website.
Main duties of the job
The CRIO Co-ordinator will ensure adherence to Research Governance in accordance with national and international regulatory frameworks including Medicines for Human Use (Clinical Trials) Regulations 2004 and subsequent amendments, International Conference for Harmonisation of Good Clinical Practice, UK Policy Framework for Health and Social Care Research and other applicable UK law (Medical Device Regulations, IRMER, ARSAC, Human Tissue Act, Data Protection Act and Mental Capacity Act).
In support of this, the post holder will provide advice and support to Investigator teams and Directorate Research Coordinators, in their designated Trust directorates and act as their main point of contact including:
- Pre-Award/Submissions
- Post-Award Governance/study set up
- Post-Authorisation/ Research facilitation
About us
You will be working for an organisation which values and respects all of its staff and the community it serves. The Trust is a leader in the NHS and research sectors and provides excellent benefits for its employees. This includes commitments to professional development but also many policies to support employees in balancing their personal and professional lives.
This vacancy is advertised on a fixed term contract basis for the maximum period of 23 months. Where there is potential, the secondment/fixed term contract may finish early, or in the first instance, the secondment/fixed term contract may be extended due to the internal/external secondment of the substantive post holder. The fixed term contract status of the post holder will be reviewed in accordance with the Trust's legal obligations regarding fixed term contracts and secondments in relation to the substantive post holder.
Please note all existing NHS staff will only be considered on a secondment basis. This must first be agreed with your current line manager.
Job description
Job responsibilities
Please view the attached Job Description and Person Specification documents for full details regarding this post.
When completing your application please ensure that you clearly demonstrate how you meet the role criteria.
Job description
Job responsibilities
Please view the attached Job Description and Person Specification documents for full details regarding this post.
When completing your application please ensure that you clearly demonstrate how you meet the role criteria.
Person Specification
Education and Qualifications
Essential
- Educated to masters level in health-related/biomedical sciences or Registered Nurse/AHP qualification and research qualification or equivalent experience
Desirable
- PhD
- Post-graduate certificate in Clinical Research
- Teaching qualification
Experience
Essential
- Experience of clinical or biomedical research in an NHS, academic or commercial environment
- Experience of co-ordinating pharmaceutical research or grant funded research
Desirable
- Experience of clinical research audit, monitoring and inspection
- Experience in a variety of clinical settings
Skills and Knowledge
Essential
- Knowledge of the research process and research methods applicable to health settings
- Knowledge of Department of Health/NIHR research strategy
- Knowledge of research legislation including research governance, GCP and Medicines for Human Use Regulations
- Knowledge of HRA and governance arrangements for ethics
- Proven project and organisational skills
- Experience of tutoring and teaching
- IT skills
- Ability to interpret complex documents including European and national legislation, Department of Health policies and Acts of Parliament
Desirable
- Experience of designing teaching materials
Personal Qualities
Essential
- Highly motivated
- Highly organised
- Ability to work independently
- Demonstrable attention to detail
- Excellent written communication skills
- Excellent interpersonal skills
- Proven ability to develop effective working relationships with staff at all levels
- Proactive in fulfilling needs of researchers
Person Specification
Education and Qualifications
Essential
- Educated to masters level in health-related/biomedical sciences or Registered Nurse/AHP qualification and research qualification or equivalent experience
Desirable
- PhD
- Post-graduate certificate in Clinical Research
- Teaching qualification
Experience
Essential
- Experience of clinical or biomedical research in an NHS, academic or commercial environment
- Experience of co-ordinating pharmaceutical research or grant funded research
Desirable
- Experience of clinical research audit, monitoring and inspection
- Experience in a variety of clinical settings
Skills and Knowledge
Essential
- Knowledge of the research process and research methods applicable to health settings
- Knowledge of Department of Health/NIHR research strategy
- Knowledge of research legislation including research governance, GCP and Medicines for Human Use Regulations
- Knowledge of HRA and governance arrangements for ethics
- Proven project and organisational skills
- Experience of tutoring and teaching
- IT skills
- Ability to interpret complex documents including European and national legislation, Department of Health policies and Acts of Parliament
Desirable
- Experience of designing teaching materials
Personal Qualities
Essential
- Highly motivated
- Highly organised
- Ability to work independently
- Demonstrable attention to detail
- Excellent written communication skills
- Excellent interpersonal skills
- Proven ability to develop effective working relationships with staff at all levels
- Proactive in fulfilling needs of researchers
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).
