Job summary
The post-holder will work on the National Institute for Health Research (NIHR) funded Culturally-adapted Family Intervention (CaFI) Project.
CaFI is a multi-site randomised controlled trial (RCT) of a family intervention co-produced with African and Caribbean service users diagnosed with schizophrenia spectrum disorders and their families. People of African and/or Caribbean origin (including people who identify as Black British, Black African, Black Caribbean, or Mixed heritage) are more likely to be diagnosed with schizophrenia and related psychoses than other ethnic groups in the UK.
National Institute for Health and Care Excellence (NICE) highlight a need for culturally-adapted psychosocial interventions for this group.
The Trial Manager will coordinate multifunctional team(s) comprising: academics, clinicians, statisticians, research assistants, and Experts by Experience such as service users and carers (PPI contributors) to project manage CaFI throughout its lifecycle.
This is a full-time post and is fixed-term for 6 months in the first instance with potential for extension following a review meeting in with the funder September 2023. The post-holder will be involved in participant recruitment, data collection, data analysis, and dissemination including preparing the final study report, academic papers, and conference presentations.
Main duties of the job
Take overall responsibility for the efficient day-to-day management of the CaFI clinical research trial.
Ensure all trial procedures are developed according to Research Governance Framework, National Research Ethics Committee (REC), Medical Research Council guidelines for Good Clinical Practice (GCP) and Data Protection, including providing assurance that personal and confidential information is restricted to those entitled to know.
Ensure recruitment of participants occurs in line with the project plan across participating sites.
Oversee a secure randomisation system in liaison with theKings College Clinical Trials Unit (KCTU) in accordance with the trial protocol.
Work with the Chief Investigator (CI), the study team, and relevant bodies, organisations, and groups to ensure that the trial meets its targets.
About us
Greater Manchester Mental Health (GMMH) Foundation Trust employs over6,400members of staff, who deliver services from more than160locations.
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
See attached detailed job description and person specification:
The role requires a research professional with experience and excellence in clinical trials conduct and management, including familiarity with the regulatory environment surrounding clinical trials. There is an opportunity for the post holder to gain a formal qualification in clinical trials management as part of continued professional development (CPD).
Take overall responsibility for the efficient day-to-day management of the CaFI clinical research trial.
Ensure all trial procedures are developed according to Research Governance Framework, National Research Ethics Committee (REC), Medical Research Council guidelines for Good Clinical Practice (GCP) and Data Protection, including providing assurance that personal and confidential information is restricted to those entitled to know.
Ensure recruitment of participants occurs in line with the project plan across participating sites.
Oversee a secure randomisation system in liaison with the
Kings College Clinical Trials Unit (KCTU) in accordance with the trial protocol.
Work with the Chief Investigator (CI), the study team, and relevant bodies, organisations, and groups to ensure that the trial meets its targets.
Establish procedures to ensure adherence to trial protocols and administrative requirements.
Coordination of study sites throughout the life cycle of the project, including liaison with R&D departments, site initiation visits, site file maintenance, site research assistants and site PIs.
Development and safe keeping of research data files, ensuring that all research data are kept in line with ethical approval and governance procedures.
Monitor blindness procedures and ensure appropriate action when the blind is broken.
Monitor adverse events and ensure timely and appropriate action is taken.
Job description
Job responsibilities
See attached detailed job description and person specification:
The role requires a research professional with experience and excellence in clinical trials conduct and management, including familiarity with the regulatory environment surrounding clinical trials. There is an opportunity for the post holder to gain a formal qualification in clinical trials management as part of continued professional development (CPD).
Take overall responsibility for the efficient day-to-day management of the CaFI clinical research trial.
Ensure all trial procedures are developed according to Research Governance Framework, National Research Ethics Committee (REC), Medical Research Council guidelines for Good Clinical Practice (GCP) and Data Protection, including providing assurance that personal and confidential information is restricted to those entitled to know.
Ensure recruitment of participants occurs in line with the project plan across participating sites.
Oversee a secure randomisation system in liaison with the
Kings College Clinical Trials Unit (KCTU) in accordance with the trial protocol.
Work with the Chief Investigator (CI), the study team, and relevant bodies, organisations, and groups to ensure that the trial meets its targets.
Establish procedures to ensure adherence to trial protocols and administrative requirements.
Coordination of study sites throughout the life cycle of the project, including liaison with R&D departments, site initiation visits, site file maintenance, site research assistants and site PIs.
Development and safe keeping of research data files, ensuring that all research data are kept in line with ethical approval and governance procedures.
Monitor blindness procedures and ensure appropriate action when the blind is broken.
Monitor adverse events and ensure timely and appropriate action is taken.
Person Specification
Education & Qualifications
Essential
- 1st or 2:1 Honours degree (or equivalent) in health sciences, social sciences (or related) with knowledge of the subject area.
- Master's degree in relevant subject area or equivalent experience.
Desirable
- PhD in relevant subject area or equivalent experience
Experience
Essential
- Track record of successfully managing clinical trials.
- Clear understanding of and interest in mental health or health services research.
- Relevant experience of managing and supervising research and other staff e.g., within NHS and/or Higher Education Institution (HEIs) environments.
Desirable
- Experience of working with diverse communities - specifically Sub-Saharan African and Caribbean communities.
- Experience of conducting semi-structured interviews used in psychosis research including the Positive and Negative Syndrome Scale (PANSS).
Knowledge & Skills
Essential
- Knowledge of implementing randomised controlled trials e.g., understanding of governance and legislative processes, blinding and unblinding procedures etc.
- Sound knowledge of research into psychosocial interventions for psychosis.
- Ability to work independently, to problem solve, be self-motivated, and to manage time and trial resources appropriately.
Desirable
- Understanding/knowledge of issues relating to mental illness in the Sub-Saharan African and Caribbean communities in the UK.
Person Specification
Education & Qualifications
Essential
- 1st or 2:1 Honours degree (or equivalent) in health sciences, social sciences (or related) with knowledge of the subject area.
- Master's degree in relevant subject area or equivalent experience.
Desirable
- PhD in relevant subject area or equivalent experience
Experience
Essential
- Track record of successfully managing clinical trials.
- Clear understanding of and interest in mental health or health services research.
- Relevant experience of managing and supervising research and other staff e.g., within NHS and/or Higher Education Institution (HEIs) environments.
Desirable
- Experience of working with diverse communities - specifically Sub-Saharan African and Caribbean communities.
- Experience of conducting semi-structured interviews used in psychosis research including the Positive and Negative Syndrome Scale (PANSS).
Knowledge & Skills
Essential
- Knowledge of implementing randomised controlled trials e.g., understanding of governance and legislative processes, blinding and unblinding procedures etc.
- Sound knowledge of research into psychosocial interventions for psychosis.
- Ability to work independently, to problem solve, be self-motivated, and to manage time and trial resources appropriately.
Desirable
- Understanding/knowledge of issues relating to mental illness in the Sub-Saharan African and Caribbean communities in the UK.
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).
