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, on-going 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 development and submission of related publications and grant applications.

Main duties of the job

Take overall responsibility for the efficient day-to-day management and close-out of the CaFI clinical research trial.

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.

Maximise data collection across participating sites in line with the trial protocol.

Oversee data completion, management, cleansing 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 ethical obligations.

Ensure adherence to trial protocols and administrative requirements.

Coordination of study sites, including liaison with R&D departments, site initiation visits, site file maintenance, site research assistants and site PIs.

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.

Monitor blindness procedures and ensure appropriate action when the blind is broken.

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

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.