Job summary
To co-ordinate clinical trials for both Mental Health and Dementia specialties within GMMH from trial feasibility through to archiving. To ensure that comprehensive, high quality and efficient administrative processes are in place for setting up trials, organising necessary approvals (HRA, Ethics, MHRA, R&D, research networks etc.), data management, close-down ensuring full compliance with the regulatory framework; including financial management of study set-up costs and income recovery for all clinical trials in conjunction with the R&I finance team.
Main duties of the job
The post holder will be responsible for co-ordination of clinical trials within the GMMH clinical trials team in conjunction with the Principal Investigator. Close liaison is required between the researchers leading studies, the sponsors and the Regional Research Delivery Network.
To co-ordinate clinical trials in conjunction with study leads, senior investigators, research nursing staff and the Research Initiation & Delivery Manager.
To assist senior staff within clinical services and the Research & Innovation team with study management across the department as required.
About us
Greater Manchester Mental Health (GMMH) Foundation Trust employs over 7000 members of staff, who deliver services from more than 122 locations.
We provide inpatient and community-based mental health care for people living in Bolton, the city of Manchester, Salford,Trafford and the borough of Wigan, and a wide range of specialist mental health and substance misuse services across Greater Manchester, the north west of England and beyond.
Greater Manchester is one of the world's most innovative, original and exciting places to live and work. From the beauty of the surrounding countryside to the heart of the vibrant inner city with great shopping, entertainment and dining options.
Wherever you go you will experience a great northern welcome with people famed for their warmth, humour and generosity.
Our people enjoy their work, have opportunities to learn and develop their skills and are encouraged to generate new ideas that improve care for our service users.
Job description
Job responsibilities
Please see attached job description and person specification
Staff benefits
- Pay Enhancements
- 27 days annual leave plus bank holidays rising to 29 after 5 years and 33 days after 10 years
- Excellent pension
- Cycle to work scheme
- Salary sacrifice car scheme
- Wellbeing programme
- Blue Light Card Discounts
- fuelGenie Fuel Cards (for applicable roles)
Job description
Job responsibilities
Please see attached job description and person specification
Staff benefits
- Pay Enhancements
- 27 days annual leave plus bank holidays rising to 29 after 5 years and 33 days after 10 years
- Excellent pension
- Cycle to work scheme
- Salary sacrifice car scheme
- Wellbeing programme
- Blue Light Card Discounts
- fuelGenie Fuel Cards (for applicable roles)
Person Specification
Education / Qualifications
Essential
- Degree in a science or health related discipline or a degree in another field with experience in clinical trials.
- An understanding of the clinical trial process
Desirable
- Post graduate certificate in clinical research or other post graduate qualification/experience.
Experience
Essential
- Experience in Clinical Trials administration, including setup, data collection, audit and project coordination.
- Experience of the governance and approval systems within the NHS and UK RRDN for clinical studies.
- Data quality management
Desirable
- Previous NHS experience.
- Evidence of writing policies and procedures and evaluating their application in practice.
- Research project monitoring.
- Experience and understanding of clinical trials in community services.
Knowledge
Essential
- Sound knowledge of all aspects of research governance and related legislation and inspection requirements (e.g. MHRA, HTA,).
Desirable
- Understanding of clinical trials and medical terminology particularly in relation to mental health and dementia
Skills and Abilities
Essential
- Excellent organisational skills, with a methodical approach and the ability to pay attention to detail.
- Ability to work as part of a team and experience of interdisciplinary working.
- Excellent written and verbal communication skills
- Ability to prioritise own and others workload and practice effective time management.
- Ability to work under pressure and to tight or unexpected deadlines.
- Advanced IT skills with a good working knowledge of IT packages and databases
Desirable
- Project management skills.
Other Requirements
Essential
- Able to work independently and flexibly Supportive Enthusiastic Positive Approachable
- There is a frequent requirement to travel mainly between the R&I Offices in Central Manchester and Prestwich and an occasional requirement to travel across the wide footprint of the Trust to attend meetings and events relevant to the role.
Person Specification
Education / Qualifications
Essential
- Degree in a science or health related discipline or a degree in another field with experience in clinical trials.
- An understanding of the clinical trial process
Desirable
- Post graduate certificate in clinical research or other post graduate qualification/experience.
Experience
Essential
- Experience in Clinical Trials administration, including setup, data collection, audit and project coordination.
- Experience of the governance and approval systems within the NHS and UK RRDN for clinical studies.
- Data quality management
Desirable
- Previous NHS experience.
- Evidence of writing policies and procedures and evaluating their application in practice.
- Research project monitoring.
- Experience and understanding of clinical trials in community services.
Knowledge
Essential
- Sound knowledge of all aspects of research governance and related legislation and inspection requirements (e.g. MHRA, HTA,).
Desirable
- Understanding of clinical trials and medical terminology particularly in relation to mental health and dementia
Skills and Abilities
Essential
- Excellent organisational skills, with a methodical approach and the ability to pay attention to detail.
- Ability to work as part of a team and experience of interdisciplinary working.
- Excellent written and verbal communication skills
- Ability to prioritise own and others workload and practice effective time management.
- Ability to work under pressure and to tight or unexpected deadlines.
- Advanced IT skills with a good working knowledge of IT packages and databases
Desirable
- Project management skills.
Other Requirements
Essential
- Able to work independently and flexibly Supportive Enthusiastic Positive Approachable
- There is a frequent requirement to travel mainly between the R&I Offices in Central Manchester and Prestwich and an occasional requirement to travel across the wide footprint of the Trust to attend meetings and events relevant to the role.
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).
