Senior Clinical Trials Co-ordinator | Greater Manchester Mental Health NHS Foundation Trust
| Posting date: | 29 April 2024 |
|---|---|
| Salary: | Not specified |
| Additional salary information: | £35,392 - £42,618 per annum |
| Hours: | Full time |
| Closing date: | 29 May 2024 |
| Location: | Manchster, M13 9WL |
| Company: | Greater Manchester Mental Health NHS Foundation Trust |
| Job type: | Contract |
| Job reference: | 6119370/437-6119370 |
Summary
The Equality, Diversity, and Inclusion Research Unit (EDI-RU)is a collaboration between Greater Manchester Mental Health NHS Trust and The University of Manchester. EDI-RU is committed to undertaking research to tackle inequalities in mental healthcare, improve mental health outcomes for under-served populations, bridge the ‘research to practice gap. Our multi-faceted, inter-disciplinary distinctive co-production approach with service users, carers, and service providers as partners will enable our unique contribution to research and practice.
Our vision is to place the EDI-RU at the forefront of research, building capacity that better understands and harnesses people’s lived experiences to develop interventions, learning, and practice that help to achieve our strategic aims, ensuring commitment to integrated care policies and procedures.
An experienced Senior Clinical Trials Co-ordinator (SCTC) is required to support the work of GMMH’s Equality, Diversity & Inclusion Research Unit (EDI-RU). This involves but is not limited to day-to-day management of clinical trial activities and coordination of the trials across multiple sites.
The Senior Clinical Trials Coordinator is required to manage the research portfolio of both the Mental Health and Dementia specialities within EDI-RU unit which is an integral part of Research & Innovation (R&I), acting as professional lead for the programme of work.
To ensure that comprehensive, high quality and efficient administrative processes are in place for setting up studies, organising necessary approvals (ethics, HRA, local R&D, MHRA, research networks etc.), data management, ensuring full compliance with the UK Policy Framework for Health and Social Care Research; including financial management of study set-up costs and income recovery in conjunction with the R&I finance team.
The SCTC is expected to conduct literature reviews and searches to support and inform grant writing, and producing academic outputs – primarily papers, reports, and conference abstracts/presentations. The postholder will also have skills in mixed methods research (data collection, analysis, and dissemination) and knowledge and experience of research with groups currently under-represented in research. They will have a keen interest in involving patients, families and carers, members of the public, and other key stakeholders in research. Accordingly, the post requires excellent communication, interpersonal, and workload/task management skills. Opportunities to pursue professional development will be agreed with the line manager.
Greater Manchester Mental Health (GMMH) Foundation Trust employs over 6,400 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.
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
This advert closes on Monday 13 May 2024