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Greater Manchester Mental Health NHS Foundation Trust

About

Greater Manchester Mental Health (GMMH) Foundation Trust employs over 7000 members of staff, who deliver services from 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.

Contact

Address: Bury New Road; Prestwich; Manchester; M25 3BL
Contact Number: 0161 938 5253

Find out more

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Closed

Ref: 437-6119370 Vacancy ID: 6119370

Senior Clinical Trials Co-ordinator

Closed for applications on: 14-May-2024 10:11

Vacancy status: Closed

Closed for applications on: 14-May-2024 10:11

Location

Site: Equality, Diversity and Inclusion Research Unit, Greater Manchester Mental Health NHS Foundation Trust, Rawnsley Building
Address: Hathersage Road
Town: Manchster
Postcode: M13 9WL
Major / Minor Region: Manchester

Contract type & working pattern

Contract: Fixed term: 9 months (FTC End Date: March 2025. The duration of the post and extension of the period beyond 9 months is subject to additional funding for the study)
Hours: Full time - 37.5 hours per week (Happy to discuss flexible working)

Salary

Salary: £35,392 - £42,618 per annum
Salary period: Yearly
Grade: (Band 6)

Specialty

Main area: Mental Health

Detailed job description and main responsibilities

Study set-up

To act as a point of contact with study sponsor, Clinical Trials Units, Clinical Research Organisations, R&I and NIHR/ CRN Research Networks.
To liaise with and assist the study team regarding Research Ethics, HRA, and other regulatory submissions and funding arrangements.
To liaise with the line Manager, clinical trials team, and R&I finance team regarding feasibility and resource requirements of studies, after discussion with the lead investigator
To liaise with the R&I to gain Trust R&I approval
To liaise with NIHR LCRN for studies adopted to the portfolio.
For multi-centre studies, to lead on study initiation at the study sites according to regulatory requirements, including training staff in specific requirements.
For co-ordination of multi-centre studies, to travel to other centres and undertake study related duties as required
For multi-centre studies, to ensure, recruitment are at an acceptable level at each centre. Suggest and implement strategies for improving recruitment.
To be responsible for setting-up, maintaining and participating in effective and efficient communication processes with all stakeholders
To ensure Trial Steering Committees and Data Monitoring Committees are set up, and meetings organised as appropriate.
To draft and assist in the development of trial documents such as Schedules of Investigations, Patient Information Sheets, Informed Consent Forms, GP letters, data sheets, Case Report Forms and Adverse Event forms
To ensure the study team has the capacity to conduct the study within its current workload and activity

Study Conduct

To implement and carry out procedures to ensure the team is compliant with the principles of Good Clinical Practice, the UK Policy Framework for Health and Social Care Research and all regulatory legislation in their day to day practice.
In liaison with the research team, implement protocols to ensure that study specific investigations are carried out correctly and in a timely manner; scheduling patient follow-up visits and assessments (including those with other departments within the Trust, or as per study requirements) to ensure protocol compliance.
To develop department and/or trial specific Standard Operating Procedures (SOPs) and Work Instructions where appropriate, ensuring they are revised and distributed as specified to the relevant teams.
To ensure tissue and biomaterial collection and storage is implemented according to SOPs and liaise with the Trust’s HTA licence manager regarding collection, storage and transfer of tissue samples when there are compliance queries.
To keep abreast of Trust-wide research SOPs and policies and ensure the research team are aware and conducting research according to these SOPs and policies.
To ensure study Site/Master Files are maintained and kept inspection-ready at all times.
To liaise with study investigators and nurses to obtain documentation on contact details, qualifications, CVs and other relevant documentation for study use.
To ensure timely and efficient procedures for collection, electronic input and verification of all patient data, chasing of missing or incomplete data and raising queries as appropriate.
To monitor data quality and to set up Quality Control procedures.
To process and communicate amendments according to GCP and Trust SOPs.
To have the appropriate administrative processes in place to ensure, with the investigators, that Adverse Event and Incident forms are completed, reported and followed up to resolution as the study protocol and regulations require.
To provide progress and other reports, as required, to all relevant parties; prepare presentations on behalf of the study team, and take part in study/team meetings.
To communicate with the Trust Research Office, sponsors, funders, pharmaceutical companies, internal and external study personnel and outside agencies in a professional manner, maintaining an efficient flow of information to sustain smooth running of the study.
To ensure all study documents are archived according to sponsor and Trust requirements and SOPs/policies, and a formal retrieval system is in place within research team.
To be proactive in monitoring working practices and suggesting improvements and new ways of working.

Study delivery and targets

To monitor performance within the research team.
To ensure R&I targets for study set-up are achieved within agreed timeframes and resolve issues locally or escalated in a timely fashion to the line Manager.
To ensure R&I KPIs (Key Performance Indicators; including but not limited to time to recruit first patient, patient recruitment to time and target) are recorded in a timely and accurate manner.
To inform the Principal Investigators (and R&I ) where there are problems or delays in recruiting patients, achieving targets or issues within the clinical trials team that will impact on the delivery of the proposed studies for the Trust.
To initiate and lead on internal audits and robust risk management of study activity to determine governance compliance, including responding to the Trust Research Self-Assessment Exercise.
To work with colleagues to provide information for Trust-wide electronic information systems tracking recruitment targets and speciality activity.

Clinical Study Financial and Resource Management

To confirm with the investigator that tasks and timings within financial templates are appropriate for the study and discuss with the line Manager and R&I finance team if further negotiations are required.
To ensure financial arrangements are in place for studies with the R&I finance team, including cost recovery, invoicing, and travel expenses.
To ensure all payments throughout the study are paid and tracked efficiently.
To identify any resource issues in administrative workload within the team.
With the assistance of the line Manager and Director of EDI-RU, prioritise and delegate the administrative workload ensuring efficient management and delivery of research study activity.

Human Resources Management

To provide line management to Administrators and Research Assistants, as required.
To supervise the day-to day activities of administrative staff.
To assist with recruitment, retention, and any staffing issues
To actively manage sickness/absence to agreed targets.
To ensure all staff have an annual performance review and their development needs identified in a Personal Development Plan.
To ensure Trust mandatory training is undertaken and recorded within R&I within specified time limits for new staff; Trust mandatory training; Moving & Handling training and any other training needs identified.
To co-ordinate the education and training needs of administrative staff, ensuring the objectives of R&I and the Trust are reflected.

Trust Mandatory On-going Requirements - to be met by the candidate after commencing in post, these will not be assessed at the recruitment stage

To undertake any other reasonable duty, when requested to do so by an appropriate Trust manager.
To understand and comply with all Trust policies, procedures, protocols and guidelines.
To understand the need to safeguarding children and vulnerable adults and adhere to all principles of safeguarding.
To carry out duties and responsibilities of the post in accordance with Equal Opportunities, Equality and Diversity and dignity in care/work policies and principles
To access only information, which is authorised to you as part of the duties of your role.
Not to communicate to anyone or inside or outside the NHS, information relating to patients, services users, staff, contractors or any information of a commercially sensitive nature, unless done in the normal course of carrying out the duties of the post and with appropriate permission.
To maintain high standards of quality in corporate and clinical record keeping ensuring information is always recorded accurately, appropriately and kept up to date.
To ensure their day to day activities embrace sustainability and reduce the impact upon the environment
Take reasonable care of the health and safety of yourself and other persons
To contribute to the control of risk and to report any incident, accident or near miss
To protect service users, visitors and employees against the risk of acquiring health care associated infections.
To take responsibility for your own learning and development by recognising and taking advantage of all opportunities to learn in line with appraisal and supervision.

Please see attached job description and person specification

Staff benefits

Pay Enhancements – 30% additional for Evenings (8pm onwards) and Saturdays and 60% additional for Sundays and Bank holidays.
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

Important Information about working for GMMH:

All positions within the Trust are subject to satisfactory pre-employment checks, for further information on the checks required please visit the NHS Employers website www.nhsemployers.org

The Trust mandates all post holders who require a DBS for their role to subscribe to the DBS Update Service. You will be required to enrol for this service for a fee of £16 per year and maintain registration throughout your employment with GMMH.

Applicants are encouraged to apply for posts at Greater Manchester Mental Health who have direct experience of mental health, learning disability or drug and alcohol services either as a service user or a carer.

The Trust is also committed to safeguarding children, young people and vulnerable adults and requires all staff and volunteers to share this commitment.

We are aspiring to ensure our workforce is representative of the diverse communities that we serve, and we are strongly committed to removing barriers to employment for candidates from under-represented groups, for example BAME, Disabled and LGBT+ communities. If you would like to have an informal chat about the recruitment process for this role or would value some additional support, we’d love to hear from you.

Use of Artificial Intelligence (AI) when writing job applications

A candidate may utilise the help of AI when writing job application. The assessment of an application is made on its entirety and most times AI-generated content does not fully grasp the context and requirements of the job one applies for thus producing inaccurate and misleading information, especially in the supporting statement section of an application that can lack real life examples of one’s achievements, success and challenges.

We have added a disclaimer to our application process advising that the use of AI is monitored. GMMH reserves the right to follow up with a candidate at the interview on specific responses and those examples used in the supporting statement to explore it further.

Sponsorship

We are proud to be an approved sponsor for the Skilled Worker visa. Applications from individuals who require sponsorship will be considered alongside all other applications. Please be aware that not all roles are eligible for sponsorship. You can review the list of eligible roles and salary requirements on the UK Government’s website – click here.

If you are offered a role with us and you require sponsorship, we will check your eligibility in line with the information on the above website. Your offer of employment could be withdrawn if the role is not eligible for sponsorship, and you are not otherwise able to evidence your right to work in the UK.

The Home Office introduces new changes from 22/07/2025 that impact the health and care sector, you may wish to familiarise with it here.

Do you have experience outside the NHS?

We want to attract and retain people with diverse skills and experience, to deliver inclusive healthcare services to our communities.

We will consider relevant experience outside the NHS to calculate your salary on appointment. Please contact our Recruitment Team for more information.

**Please note, this vacancy may be closed at any time if sufficient applications have been received**

Applicant requirements

This post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service.

Person specification

Desirable

Essential criteria

Degree in a science or health and social care-related discipline, or a degree in another field with experience in clinical trials.
Experience in Clinical Trials Management, including set up, financial management, data collection, audit and project management.
Experience of the governance and approval systems within the NHS and UK CRN for clinical studies.

Desirable criteria

MSc or an equivalent qualification in clinical trials or a health-related discipline.
Evidence of structured managerial training and continuing professional development, a managerial qualification or proven experience.

Essential

Essential criteria

Experience of the governance and approval systems within the NHS and UK CRN for clinical studies
At least two years experience of experience of the governance