Agile Research Delivery Team Clinical Research Practitioner

• Clinical trials and other well-designed health and social care research studies (including studies that are delivered outside of an NHS setting)
• Public health studies that require the recruitment of individuals within an NHS setting (that is, acute, ambulance, mental health, community or primary care) or an episode of care which involves contact with the NHS.

• Accurately perform and record a range of participant assessments and physiological measurements required, according to personal competencies and the study protocol. This may include, but not be limited to; venepuncture, blood pressure, urinalysis, weight and height.
• Appropriately document and report any serious adverse events and incidents according to regulatory requirements.
• Ensure that relevant approvals are in place prior to commencing a study.
• Using appropriate manual and computerised systems, ensure accurate collection and maintenance of all research records and results, ensuring that all data can be verified.
• Provide timely information and reports to reflect recruitment of patients including timely entry to Local Project Management Systems (LPMS).
• Raise awareness of problems relating to IT and software systems, and work with the Senior Agile Research Delivery Nurse/ AHP/ CRP and IT departments to resolve them e.g. problems with online data submission forms.

• Understand complex information and data to support decisions and plans relating to the Agile Research Delivery Team.
• In collaboration with the Study Support Service, facilitate implementation of Information Governance best practice within systems supporting the operation of the Agile Research Delivery Team and wider care settings.
• Ensure data integrity within relevant RDN systems, identifying potential concerns and patterns, and advising RDN customers and partners in resolving issues.
• Undertake the processes required to continually ensure high quality and integrity of data within the portfolio management systems.
• Support the use of digital innovations including data visualisation tools/dashboards and digital recruitment services to inform study and process decision making.
• Actively contribute to activities and service processes that support wider care settings study sponsors, funders and investigators to access data to enable them to effectively manage the delivery of their studies (and enable them to request support from the RDN as required).
• Utilise operational activity data for cost attribution and allocation of studies, ensuring accurate data support for regional wider care organisations.
• In collaboration with the Study Support Service, ensure compliance with the DHSC RDN Portfolio Policy that the process, procedure and monitoring of studies enables sponsors / delegates, research delivery sites and funders to understand and adhere to their roles and responsibilities. For example, this may include satisfying the Eligibility Criteria for NIHR support before they are included on the portfolio and subsequently adhering to the expected actions and requirements set out in the NIHR RDN Portfolio Terms and Conditions.
• Contribute to the oversight of the RDN wider care settings portfolio to proactively identify potential issues and opportunities, working as an active partner to resolve and action follow-up activity.
• Support relevant Study Sponsors and delegates in the utilisation of the Sponsor Engagement Tool to secure visibility of real-time research activity data and help identify capacity in the health and care research system to deliver research quickly and efficiently.
• Actively contribute to the coordination of the National Specialty and Setting Groups (e.g. arranging meetings, taking notes).
• Provide administrative support (e.g. note-taking and action tracking) to facilitate operational and project delivery and to capture learnings and knowledge for national network benefit.

Essential

• Educated to degree level
• CRPs should be on, or working towards accredited registration with the AHCS

Essential

• Knowledge of the governance and legislative framework for conducting clinical research studies, including ICH Good Clinical Practice.
• Knowledge of the clinical trial and health and care research lifecycle including experience of the set up and delivery of research studies in a health and care setting.
• Experience of the care of patients/participants enrolled in research studies or a customer focussed role.

Essential

• Good IT skills, particularly in the use of Web applications, MS Office and/or Google Hub applications.
• Ability to plan and coordinate multidisciplinary activities associated with the management and delivery of research study(ies)