Job overview
Acting as first point of contact for both internal and external researchers and their teams to run their research at the Trust, the RAPM is responsible for project managing studies from first contact to site initiation. They will lead the coordination of all relevant tasks associated with setting up research studies at the Trust including but not limited to engaging multi-disciplinary staff and support services both internally and external to the Trust. Working closely with the research delivery team, the post-holder will contribute to and drive high quality feasibility that is robust and representative of the care pathways and capacity demands involved in the successful delivery of research.
As part of the Research Access Team the RAPM will work to national performance metrics including those around around the initiation and set up of research in the support of the UK Life Sciences agenda.
Main duties of the job
Communicate effectively with all staff involved in research studies, including Principal Investigators, departmental managers, and trial sponsorship offices. Build internal and external networks to support feasibility processes, from study commencement to site opening, ensuring compliance with Health Research Authority (HRA) governance and Medicines and Healthcare products Regulatory Agency (MHRA) standards, including international equivalents.
Use the EDGE Local Portfolio Management System to manage studies and update the team. Respond promptly to information requests for local and national reporting (e.g., NIHR, RDN/RRDN). Meet regularly as a team to ensure consistent, high-quality service.
Act as the first point of contact for researchers via the Research Access Team’s ‘front door’ model. Coordinate feasibility for all study types, including LTHTr-sponsored, commercial, and early-phase trials through NIHR Lancashire CRF. Engage relevant support services at appropriate times, including external procurement if needed. Liaise with sponsors and coordinating teams to ensure timely receipt of essential documents.
Address queries on study setup progress across the portfolio. Manage workload effectively, escalating pressures when needed. Represent the Trust with high standards of customer service to encourage repeat business and continued internal engagement.
Working for our organisation
Research helps us offer our patients and their families the high-quality care they deserve and discover new treatments. It can improve the way you manage your condition. It can contribute to the elimination of some diseases entirely. We conduct many different types of research studies across a large number of conditions. We offer our patients the opportunity to be involved in trials of new treatments through to studies using questionnaires and interviews.
The LTH has significant expertise in both the regulatory planning and delivery of research and innovation studies and trials. The Research Access Team (RAT) have both research and development backgrounds with governance expertise required to guide research and innovation projects through testing and trials phases in accordance with regulatory standards. Within the R&I team there are 5 core clinical teams (Cancer, Neurosciences, Chronic conditions (including Renal and Diabetes), Acute Conditions (including A&E, Critical care National Institute for Health Research (NIHR)‘s in England in the shape of the. LTH is distinctive in its ambition to be a driving force in connecting world class innovation education, training and research, to such a degree it positions this ambition as one of its three organisational strategic aims.
Detailed job description and main responsibilities
To communicate effectively with all disciplines of staff involved in each research study including Principal Investigators, departmental managers and trials sponsorships offices.
Develop a network of contacts internally and externally to support an effective feasibility process.
Working closely with relevant staff from Commencement of Study Site Feasibility to Site Opening.
Adherence to Health Research Authority (HRA) requirements for research governance, as per HRA approval.
Adherence to Medicines and Healthcare products Regulatory Agency (MHRA) requirements and other equivalents internationally.
Effectively utilising the EDGE Local Portfolio Management System to project manage studies and communicate progress to the rest of the team.
Provide and respond promptly to requests for information to support the local and national reporting obligations of the Trust and the NIHR e.g. RDN/RRDN, as required.
To meet regularly as a team to ensure a high quality and consistent service is provided.
As first point of contact for internal/external researchers/research teams the Research Access Team operates a ‘front door’ to conducting research at Lancashire Teaching Hospitals.
Coordinate the feasibility process for research studies before set-up, including studies sponsored by LTHTr, commercial clinical trials or early phase studies running through the NIHR Lancashire CRF.
Relevant support services are engaged as appropriate and at the correct time to allow for adequate review and approval. This may include procuring services outside the Trust.
Liaison with sponsors/trial coordinating teams for receipt of essential documents at appropriate time points.
Respond to any queries regarding the progress of set up for research studies across the portfolio.
As a responsible member of the Research Access Team, balance your workload effectively to maintain a high-quality service and escalate pressures as appropriate.
As an ambassador for the Trust you will exhibit high standards of customer service to ensure repeat business from external sponsors and continued engagement from internal colleagues.
Person specification
Qualifications & Education
Essential criteria
1. Educated to degree level or demonstrable experience
Desirable criteria
2. Project management qualification
3. IT qualification
Knowledge & Experience
Essential criteria
4. Experience of providing comprehensive administrative support to complex and evolving processes
5. Experience of working with stakeholders from various sectors and at various levels of seniority
6. Experience of working within a research environment
7. Knowledge of the principles of Good Clinical Practice (GCP) and other legislative requirements such as Human Tissue Act and the application of legislation into practice
8. Knowledge of the UK Policy Framework for Health and Social Care Research and applicable UK regulations, including oversight of commercial clinical trials
Skills & Abilities
Essential criteria
9. Organisational skills – the ability to prioritise in a fast changing environment to meet the needs of the service
10. Intermediate IT skills particularly with Excel, database programmes and Outlook.
11. Excellent communication skills – able to deliver difficult news to colleagues, stakeholders. Able to communicate complex information to people under pressure
12. Ability to plan and organise own workload with reference to the impact this has on dependant workloads within the wider team.