Job responsibilities
Communication and Key Working Relationships
- The post holder will be required to communicate effectively face to face, by e-mail, letter and telephone
- Treat all persons encountered during the course of duties with respect and courtesy and maintain a standard of conduct which best represents the clinical trials team and the Trust
- Provide on-going specialised advice and information to patients and their carers/families with regard to participation in clinical research.
- Where appropriate receive and document written informed consent from research subjects and act as an expert resource in informed consent.
- Promote collaborative working across the network and with other clinical researchers, within the CRN and NIHR structure.
- Ensure high quality publicity about clinical research is visible in the department including easy access to information about current trials for patients and the public.
Key working relationships:
Lead Research Nurse
Clinical Research Team
Principal Investigators
Research and Development Manager and associated team
SWP CRN Chief Operating Officer and Research Delivery Managers
Trust Senior Nurses and AHPs
Study participants and their families
Clinical Trials Pharmacy Manager & staff
Diagnostic services
Study sponsors and Clinical Research Associates.
Planning and Organisation
- Lead the management and delivery of a large clinical trial portfolio relevant to the Division/s and ensure a balanced portfolio of studies.
- Lead the Expression of Interest / Study Selection process for the area of responsibility. Review and assess trial protocols, consider all potential trials in terms of capacity and capability and viable recruitment period. Identify and work with the Principal Investigator (PI), RM&G Manager and Lead Nurse to resolve resource implications in delivering and facilitating clinical research.
- Monitor and plan in advance the research workload within the department and manage team performance.
- Act as an expert resource and provide complex advice regarding study set up, recruitment planning and study delivery.
- Be responsible for promoting and overseeing the appropriate referral and recruitment of patients to clinical research studies. Work with investigators and support the clinical research team to develop strategies to overcome barriers to recruitment and to solve other problems relating to specific studies.
- Decide and delegate roles for the clinical research team in terms of study delivery, using the right skill mix for the study complexity.
- Oversee the coordination of study visits including off site visits and ensure the team adhere to the lone worker policy.
- Oversee the maintenance of Trial Master Files and essential documents.
- Proactively seek feedback from participants and their families during their research involvement
- Review incident reports related to the relevant area, carrying out investigations and take appropriate action where required.
- Ensure that the team respond to data queries generated by the study coordinating team within a timely manner and review monitoring visit reports within the team
- Oversee study close down and the preparation of results of research for presentation as posters, abstracts, papers or scientific presentations.
Analytics
Analyse research management systems such as EDGE and ODP to ensure research metrics are monitored and maintained.
Utilize IT systems and research specific platforms as required eg. TrinetX.
Interpret excel spreadsheets and data provided, to understand performance position
Ensure attention to detail and accuracy in all data management
Responsibility for Patient / Client Care, Treatment & Therapy
Policy, Service, Research & Development Responsibility
- Demonstrate professional development and an in-depth knowledge of current clinical and research practice and encourage and ensure the development of others.
- Appraise research findings that inform and influence practice, policy and service provision and demonstrate the ability to make research and clinical judgments based on this appraisal.
- Ensure that the delivery of studies meet requirements with regards to the Department of Healths Research Governance Framework for Health & Social Care and the EU Clinical Trials Directive by implementing quality systems.
- Ensure that staff participate in Good Clinical Practice (GCP) training.
- Ensure clear, accurate and concise records are kept for research projects in accordance with all regulatory requirements including the Data Protection Act.
- Undertake all mandatory training and ensure that the clinical workforce is up to date with mandatory training.
- Co-operate with external and internal audit, data monitoring and quality assurance by working with R&D, sponsors, study monitors and external bodies.
Responsibility for Finance, Equipment & Other Resources
Ensure both accurate costing for clinical trials and appropriate negotiation of required financial support to deliver clinical trials.
Have an awareness of the clinical trials workforce budget and understand the various income streams including Core Network Funding, Research Capability Funding and study income.
Assist the Lead Research Nurse / Practitioner to ensure financial stability or the clinical trials workforce budget.
Manage the teams travel and training procurement costs within their area of responsibility
Ensure the clinical research team are aware of, and work within financial and budgetary guidelines.
Ensure accurate costings for clinical research workforce activity during study set up.
Oversee all relevant commercial costings within areas of responsibility and utilise planning tools such as the intensity toolkit.
Identify resource implications for individual studies and the portfolio of studies within the Division.
Ensure research equipment and medical devices are maintained in an effective working and good clinical order.
Responsibility for Supervision, Leadership & Management
- Assist the Lead Research Nurse / Practitioner to ensure the operational delivery of the clinical research teamwork plan, particularly with respect to achieving NIHR targets.
- Manage research performance in relation to team activities and study timelines and targets set by R&D and the SWP CRN.
- Collaborate with other Trusts and organisations within the region to improve research delivery.
- Keep up to date with research management issues through liaison with other Research Specialists /Team leaders and link with national networks.
- Act as line manager for the Senior Research Nurses/ Practitioners within the team and oversee the management of other members of the research staff within the team (Research Nurse/Practitioner, Clinical Trials Officers, Clinical Trials Support officer, Research HCA, Research Administrator). This will include clinical supervision and mentorship to members of staff and students.
- Ensure all staff within sphere of responsibility has access to essential training and achieve 100% compliance.
- Be responsible for the deployment of HR policies including proactively managing sickness and performance in line with the Trust policy.
- Ensure the health, safety and security of the clinical research team.
- Lead in the recruitment of Senior Research Nurses/Practitioners within the relevant team.
- Assist the Lead Research Nurse/Practitioner with the training and development of clinical research practitioners and administrators to ensure retention of staff and workforce development where possible.
- Oversee the delivery of education and training regarding research for the wider Multidisciplinary Team and act as an ambassador for research.
- Contribute to the development and implementation of clinical and research policies, and Standard Operating Procedures (SOPs).
- Facilitate and maintain effective communication within the research team and between the multidisciplinary clinical team.
- Represent the clinical research team and the Somerset NHS Foundation Trust at a regional and national level.
- Work as part of the clinical trials core operational team and contribute to the on-going development of the R&D department.
- Deputise for the Lead Research Nurse / Practitioner and provide cover for other Team Leads when required.
- Promote a blame free culture in reporting incidents and where appropriate initiating a local investigation in a timely manner.
- Resolve relevant complaints and issues at a local level in partnership with patients, carers and their family and other healthcare professionals.
- Act as a professional lead and work within the relevant professional code of conduct. (e.g. NMC Scope of Professional Practice and Code of Conduct) demonstrating accountability for own actions and awareness of own limitations.
- Ensure the on-going registration of clinical staff with relevant professional bodies.
- Oversee the recruitment of new personnel, ensure that an appropriate and safe skill mix is maintained and act strategically to enable retention of staff.
Information Resources & Administrative Duties
Assess and evaluate the progress of on-going clinical trials for area of responsibility, maintaining accurate records of the study progress and providing regular updates to the department on the status of the studies. This will involve ensuring that EDGE (Local Patient Management System) is updated with key trial data and validated efficiently.
The post holder will be required to assess team performance from Monthly Business intelligence reports in Excel
Any Other Specific Tasks Required
- Take part in regular performance appraisal.
- Undertake any training required in order to maintain competency including mandatory training, e.g. Manual Handling
