Research Facilitator

Job overview

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

Detailed job description and main 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.

• 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 department’s 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
• 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.

• 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.

ADDITIONAL REQUIREMENTS AND RESPONSIBILITIES (detail below)

• 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.

• 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

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.