Promotion of the CRN East Midlands Research Site Initiative (RSI) Scheme, and contribution to the overall growth of research cond.....
Promotion of the CRN East Midlands Research Site Initiative (RSI) Scheme, and contribution to the overall growth of research conducted in Health, Social and Primary Care in your locality. Performance management of the RSI sites against key performance indicators for the financial year Promotion of Research within Primary Care, this may include presentations to healthcare professionals/ providers and the general public.Supporting research nave Health, Social and Primary Care sites in becoming research active, this may include assisting with the delivery of research training and education Maintain an understanding of the changing landscape in Health, Social and Primary Care, with specific focus on Primary Care Networks (PCNs) Work with the CRN Study Support Service to support the facilitation of study set-up and delivery in Primary Care settings, the post holder will be expected to collaborate effectively, and engage with a diverse range of personnel including: staff members from primary care organisations, R&D staff, commercial/non-commercial sponsoring and funding organisations, chief/principle investigators (academic and NHS), heads of department, directorate leads, and staff from other Trusts. Utilising and updating the Local Performance Management System Edge, in the performance management of Primary Care sites and studies. Promoting and utlising the CRN East Midlands Primary Care Research Website and supporting sites to access and use this. Assisting sites in keeping site Research Activity Records up to date. To develop an understanding of the application of ICH GCP Guidelines, the EU Directive on Clinical Research and Research Governance.To work alongside Health, Social and Primary Care sites, ensuring staff delivering research at the sites have in date ICH GCP and Informed Consent (where appropriate) training. The following duties may be undertaken by the post holder, at times when there is a requirement for additional clinical delivery support for studies taking place in the region: To identify patients suitable for entry into clinical trials and research studies, this may include attending clinics and multidisciplinary team meetings, reviewing medical notes and inclusion/exclusion criteria. To ensure patients / carers are provided with written information relevant to the research study and are given the opportunity to discuss the research study or clinical trial adequately at the outset and during the course of the research or clinical trial in which they are being asked to participate (i.e. informed consent) To attend and support patients in the clinical environment for monitoring, assessment and follow up as part of research projects. Where appropriate, to take consent from patients/participants to enter research studies. To take relevant patient samples for clinical trials; such as blood samples, tocentrifuge and separate serum, package and dispatch as per defined protocols, where appropriate. Observe patients and monitor treatment toxicity/side effects; escalating findings accordingly. Maintain accurate patient trial documentation, complete Case Record Forms, including the use of electronic data capture systems and ensure relevant information is recorded in patients medical notes. Ensure safety data is reported to required SOPs and study protocols, and reports sent in a timely manner. To ensure safe and appropriate storage of specimens, in accordance with the trial protocol and in conjunction with specialist teams. To record and report any adverse events and serious adverse events according to trial protocol and local procedures. Develops and maintains constructive relationships whilst reconciling or resolving conflict. Be responsible for managing their own workload, working to competing deadlines, working against performance targets and resolving problems. Takes responsibility for implementing decisions and plans owned by the team. Maintain efficient and effective communication with Primary Care Team Leader on issues related to staff conduct within research trials andimpact on participant care. To be flexible in their approach to work as the role may require flexibility in terms of timing e.g. for specific treatments. In accordance with professional codes, maintain own professional development and competence to practice. Undertake data entry and assure its accuracy and timeliness to study records in both LPMS (Edge) and national (CPMS) databases and support their maintenance. Create of reports on study setup and patient recruitment, using the Open Data Platform and other NIHR Systems and use these to review data quality and to support performance monitoring and management of studies. Provide CRN assistance to audits, monitoring visits or regulatory inspections. Take responsibility for the maintenance of confidentiality, security and integrity of information relating to patients, staff and other health service members in the NHS organisation and IHSP setting of the Study Support Service. Provide research support and training for individual trials being conducted within the network region, it is expected that this will involve working on more than one project at any time and in more than one clinical specialty as appropriate. Develop training guides as required to support researchers and colleagues in understanding aspects of the Primary Care Research Delivery Team. Ensure that training pertinent to the role is up to date e.g. ICH-GCP, Edge, as well as mandatory training as directed to develop/maintain skills and knowledge. Be flexible in the approach taken to work. Be accountable for all tasks within the scope of the role and to be aware of developmental needs/limitations while providing support to others. As the post will cover a number of NHS Trusts/partner organisations, there will be a requirement to travel around the geographical area covered by the CRN: East Midlands on a frequent basis.
