CaFI Study Trial Manager

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 culturally informed psychosocial family therapy 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 (PPIE contributors) to project manage the final stages and close-out of the CaFI Trial. This will include data collection and analysis, ongoing study management, closeout, and dissemination with the Chief Investigator (CI) Professor Dawn Edge. The post holder will ensure that the study is conducted in accordance with the relevant clinical trial regulations. The post holder will also contribute to the development and submission of related publications and grant applications.

Main duties of the job

1. Take overall responsibility for the efficient day-to-day management and close-out of the CaFI clinical research trial.
2. Ensure all trial procedures are conducted 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 access.
3. Maximise data collection across participating sites in line with the trial protocol.
4. Oversee data completion, management, and cleansing in liaison with the Kings College Clinical Trials Unit (KCTU) in accordance with the trial protocol.
5. Work with the Chief Investigator (CI), the study team, and relevant bodies, organisations, and groups to ensure that the trial meets its ethical obligations.
6. Ensure adherence to trial protocols and administrative requirements.
7. Coordination of study sites, including liaison with R&D departments, site initiation visits, site file maintenance, site research assistants, and site PIs.
8. Ensure effective data management, including safe keeping of research data files, ensuring that all research data are kept in line with ethical approval and governance procedures.
9. Monitor blindness procedures and ensure appropriate action when the blind is broken.

About us

GMMH employs over 7000 members of staff, who deliver services from more than 160 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 responsibilities

As the research focuses on improving psychosis care for people of Sub-Saharan African and Caribbean origin, relevant experience of working with/understanding these communities will be considered an advantage.

Staff benefits

• Pay Enhancements:

Band
Saturday (midnight to midnight) and any week day after 8pm and before 6am
All time on Sundays and Public Holidays (midnight to midnight)

1. Time plus 47%
2. Time plus 94%
3. Time plus 41%
4. Time plus 83%
5. Time plus 35%
6. Time plus 69%
7. Time plus 30%
8. Time plus 60%

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
Experience
Essential

• Track record of successfully managing clinical trials.
• Clear understanding of and interest in mental health or health services research.
• Experience of working with Clinical Trials Units (CTUs).
• Significant experience of Research Governance and Ethics procedures.
• Experience of establishing, monitoring, and using databases in clinical trials.
• Relevant experience of managing and supervising research and other staff e.g., within NHS and/or Higher Education Institution (HEIs) environments.
• Experience of leading/coordinating multidisciplinary teams.

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.

Employer details
Employer name
Greater Manchester Mental Health NHSFT

Address
Rawnsley Building/University of Manchester
GMMH
Manchester
M25 3BL

Any attachments will be accessible after you click to apply.

437-6723397