About this role
Job summary
support and assist the set up and delivery of commercial and Alder Hey sponsored research studies from early feasibility to study close by providing a facilitating role that ensures local study teams can deliver research to the best of their ability. This ultimately involves supporting the set up, associated finance management and subsequent formation of a robust recruitment strategy ensuring the c portfolio reaches its full potential, overcoming barriers to performance, thereby ensuring smooth study delivery to MHRA and GCP standards and sponsor agreements. The role links directly with national targets and provides support for several functions related to the efficient delivery of high quality research
Main duties of the job
To support and assist the set up and delivery of commercial and Alder Hey sponsored research studies from early feasibility to study close by providing a facilitating role that ensures local study teams can deliver research to the best of their ability. This ultimately involves supporting the set up, associated finance management and subsequent formation of a robust recruitment strategy ensuring the portfolio reaches its full potential, overcoming barriers to performance, thereby ensuring smooth study delivery to MHRA and GCP standards and sponsor agreements. The role links directly with national targets and provides support for several functions related to the efficient delivery of high quality research
About us
Sponsorship - We are an approved sponsoring organisation. Applications will be considered from applicants requiring sponsorship alongside all other applications. Please be aware, not all roles are eligible for sponsorship.You can review the list of eligible role and requirements on the government website.
Job description Job responsibilities
Main Duties and Responsibilities: Primarily supporting Alder Hey commercial research and Alder Hey sponsored studies (conception to close). The post holder will be able to demonstrate flexibility and use own initiative to carry out duties in such a way as to make a direct and positive contribution to the organisation, thus enabling the study delivery teams and Principle / Chief Investigators, PI/CIs, to utilise their time in an efficient and effective manner. The post holder will provide a confident professional service to all Principal Investigators whilst supporting them through study set-up activities . It is vital that confidentiality be maintained at all times. The post holder will act in a similar professional manner to all external sponsors.
Act as an administrative point of contact for AH sponsored and commercial studies, requiring customer service attitude and high levels of professionalism Manage set up of new studies in conjunction with the PI, trial coordinators, lead research nurse, contracts & finance manager Governance Manager and QA officer Carry out the day to day co-ordination activities in order to maintain effective set-up and running of studies in accordance with protocols, ethical and regulatory approvals, SOPs, principles of GCP, EU directives and UK legislation. Work with research nurses and data managers to set up SIV and monitor visits. Meet and greet external visitors such as study monitors or sponsors to the department in a professional and polite manner. Facilitate and/or provide guidance to potential researchers, Chief and Principal Investigators, regarding the distribution of income and associated impact generated from commercial research in accordance with the research incentive scheme and quality measures expected from the commercial sponsor.
Liaise with clinical and non-clinical staff and study sponsors to resolve any day to day issues that may arise with study performance Attend and contribute to departmental meetings, team briefs etc. Support the maintenance of the feasibility database and work with CRD staff to ensure site intelligence is up to date. Adapt a flexible attitude to meet the needs of the study team, taking into consideration each departments unique specialty and the subsequent requirements of such specialist services.
Initiate an early meeting with the PI and a representative(s) of the Commercial research team to document and initiate resultant actions relating to:
Research Nurse time required to deliver study (intensity and risk) Resource issues Support service requirements PI budget management Completion of early study related documentation ensure patient recruitment and other key data is registered on the local portfolio management system
Contribute to study recruitment strategy completed by the Research Nurse and clinical teams.
act as a point of call for finance and associated income related queries. Support the encouragement of principal investigators response to and action requests for feasibility data or patient episodes within locally agreed timescales, ensuring this is recorded in appropriate data capture tools & systems
Utilise tools that enable appropriate recording and reporting of high quality data for trials within the portfolio, including but not limited to edge. Liaise with, the CRD Contracts and Finance manager regarding actions associated with Alder Hey commercially sponsored studies and their contracts. Work closely with Contracts and Finance manager in the generation and processing of documentation relating to financial accounting for commercial studies, Liaise with data administrators with regarding data entry onto trial databases and Case Report Forms, particularly on matters related to study income Have a clear understanding of individual study financial arrangements and associated recruitment targets, ensuring barriers to key performance indicators are flagged to the management team. Proactively support in identifying the most appropriate route to Achieving recruitments targets and 100% expected income.
ADDITIONAL REQUIREMENTS AND RESPONSIBILITIES (detail below)
Work with the data administration team to refine process of managing identification, screening and recruitment of participants/patients to studies in the CRD commercial research portfolio
Liaise with and assist the trial coordinators and R&D Contract and Finance manager in establishing commercial costings and associated contracts Contribute to the monitoring of the performance of clinical trials and studies within the commercial portfolio
To support study set-up within agreed timeframes and assist with any problems that can be resolved locally or escalated in a timely fashion to the CRD management team.
Quality Assurance:
Support the Research Governance Lead in operating a quality assurance system for commercial clinical research studies to ensure data quality is high and all required data is included in case report forms (CRFs) Support the Quality and Governance Lead in the development and implementation of a long-term CRD QA strategy in order to ensure that the Trust maintains a system of continuous quality improvement that meets the requirements of evolving clinical research legislation.
Provide education/training to CRD/CRF staff regarding research incentive scheme and associated finance reporting processes relating to commercial contracts Supporting the Research Governance Manager and to ensure the Trust is inspection ready at all times.
Person Specification
essential Essential
oA scientific degree relevant to medicine/healthcare OR oPrevious experience of working in a clinical research capacity, either in an administrative or co-ordinating role oknowledge of Study set-up, role and responsibilities for research studies oAbility to demonstrate good organisational skills, flexibility, and evidence of accuracy and attention to detail. I.e. competence to multi-task and work under pressure to ensure deadlines are met, while maintaining focus, clarity and accuracy of information or data.
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.
Certificate of Sponsorship 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).
Employer details Employer name Alder Hey Children's NHS Foundation Trust
Address Alder Hey NHS FT
Eaton road
Liverpool
L12 2AP
United Kingdom
Employer's website https://alderhey.nhs.uk/ (Opens in a new tab)