Swydd-ddisgrifiad a phrif gyfrifoldebau manwl

PRIMARY DUTIES & AREAS OF RESPONSIBILITY
Leadership
1. Responsible for the operational delivery of the clinical research team work-plan within the relevant specialties
2. Manage research performance within the relevant specialty in relation to team activities and study timelines.
3. Collaborate with other Trusts and organisations within the region to improve research delivery.
4. Keep up to date with research management issues through liaison with other Research Specialists /Team leaders and link with national networks.
5. Act as line manager for junior members of the research staff as applicable (e.g. Research Nurse/Practitioner, Research Assistant Practitioner, Research HCA, and Research Administrator). This will include clinical supervision and mentorship to members of staff and students.
6. Ensure all staff within sphere of responsibility have access to essential training and achieve 100% compliance.
7. Be responsible for the deployment of HR policies including proactively managing sickness and performance in line with the Trust policy.
8. Ensure the health, safety and security of the clinical research team within sphere of responsibility
9. Lead in the recruitment of Research Nurses/Practitioners within the relevant team.
10. Assist the Team Lead with the training and development of clinical research practitioners and administrators
 to ensure retention of staff and workforce development where possible.
11. Lead in the delivery of education and training regarding research for the wider Multidisciplinary Team and  act as an ambassador for research.
12. Contribute to the development and implementation of clinical and research policies, procedures and SOPs.
13. Facilitate and maintain effective communication within the research team and between the multidisciplinary clinical team.
14. Promote a blame free culture in reporting incidents and where appropriate support local investigation of  incidents.
15. Support appropriate studies within PHNT/UHP and its partner organisations as appropriate.
Research
1. Take a leading role in the delivery of a clinical trial portfolio relevant to the specialty and ensure a balanced portfolio of studies. 
2. Ensure that the delivery of studies meet requirements with regards to the Department of Health’s Research Governance Framework for Health & Social Care and the EU Clinical Trials Directive by implementing quality
 systems. 
3. Ensure that staff participate in Good Clinical Practice (GCP) training. 
4. Be responsible for the Expression of Interest / Study Selection process for the relevant specialty. Review and assess trial protocols, consider all potential trials in terms of capacity and capability and viable recruitment 
 period. Identify and work with the Team Lead to resolve resource implications in delivering and facilitating clinical research. 
5. Monitor and plan in advance the research workload within the specialty and manage team performance.  Ensure that study complexity is considered when delegating roles within the team. 
6. Act as an expert resource and provide complex advice regarding study set up, recruitment planning and study delivery. 
7. 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. 
8. Act as Principal Investigator (PI) for suitable studies and promote the non-medic PI role. 
9. Coordinate and run study visits including off site whilst adhering to the lone worker policy. 
10. Work with other departments within the Trust to ensure that trial specific investigations and procedures are undertaken as required by the trial protocol, in order to establish eligibility and safety of patients within
 clinical trials. 
11. Work with the team lead and research facilitators to ensure accurate costing for clinical trials and  appropriate negotiation of required financial support to deliver clinical trials. 
12. Ensure clear, accurate and concise records are kept for research projects in accordance with all regulatory requirements including the Data Protection Act. 
13. Ensure that data is transcribed accurately where required and assist with the maintenance of the Trial  Master File. 
14. Respond to data queries generated by the study coordinating team within a timely manner. 
15. Ensure the recording & reporting of adverse and serious adverse events that occur whilst the participant is in the clinical trial to the trial co-coordinator/Principal Investigator (PI) and R&D office in line with the study protocol, local policies and regulatory requirements. 
16. Assess and evaluate the progress of on-going clinical trials for which the post holder has responsibility,  maintaining accurate records of the status of studies 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. 
17. Identify and resolve study performance issues, escalating on-going issues to the Team Lead where required. 
18. Promote collaborative working across the network and with other clinical researchers, within the CRN and NIHR structure. 
19. 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. 
20. Co-operate with external and internal audit, data monitoring and quality assurance by working with R&D,  sponsors, study monitors and external bodies. 
21. Assist in study close down and the preparation of results of research for presentation as posters, abstracts,  papers or scientific presentations. 
Clinical & Professional
1. Take a leading role in the care of research participants within sphere of competence and provide relevant  health promotion and education. 
2. Use relevant clinical knowledge to screen and identify patients for clinical research using inclusion and  exclusion criteria and utilising NHS records, screening clinics, visiting wards and outpatients and using Trust
IT systems and databases. 
3. Act as a specialist resource and role model for all aspects of Research Clinical Practice in order to optimise  patient care and clinical practice this may include carrying out physical assessments, conducting sample
 retrieval and processing, providing or coordinating interventions and treatments, clinical monitoring. 
4. Undertake all mandatory training and ensure that the clinical workforce is up to date with mandatory training. 
5. Ensure the environment is suitable for patient care and research processes, recognising the importance of privacy, dignity and diversity. 
6. Demonstrate professional development and an in-depth knowledge of current clinical and research practice. 
7. Provide on-going specialised advice and information to patients and their carers/families with regard to their participation in clinical research in order to facilitate effective informed consent. 
8. Where appropriate receive and document written informed consent from research subjects, for their  participation in research studies and support other members of the team with best practice. 
9. Be responsible for the safe and accurate collection of research data through clinical procedures such as venepuncture, history taking, standard observations (height, weight, BP, RR, HR, SpO2 temperature) and  other assessments such as ECG, physical examinations, disease specific outcome measures,  questionnaires, rated scales, qualitative interviewing as required by the protocol. 
10. Monitor treatment toxicity/side effects and initiate changes to treatment as required by the protocol.  Escalate any concerns to the Principle Investigator or relevant physician and act as a support to other 
 members of the team. 
11. Centrifuge, process, track and ship samples in line with protocol requirements. 
12. Ensure the safe administration of any treatments and drugs given within the context of a clinical trial and act as a specialist clinical resource to the members of the team. 
13. Ensure accurate patient trial documentation, including the use of electronic data capture systems and  ensure relevant information is recorded in patients’ medical notes in a timely manner. 
14. Refer to other specialists as required in order to provide optimal care of the participant. 
15. Monitor clinical standards within the research team and escalate any persistent issues to the Team Lead. 
16. 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. 
17. Work within the relevant professional code of conduct, demonstrating accountability for own actions and  awareness of own limitations. 
18. Provide cover for other Research Nurses/ Practitioners as required, within sphere of competency. 
19. Proactively seek feedback from participants and their families during their research involvement on the standard of information and care that they have received including participating in the clinical trials patient 
 feedback survey.
Resources
1. Lead the recruitment of new junior personnel and ensure that an appropriate and safe skill mix is  maintained. Work with the Team Lead to promote retention of staff. 
2. Have an awareness of the income stream relevant to Clinical Trials and work within, local and Trust wide financial and budgetary guidelines. 
3. Ensure accurate costings for clinical research activity during study set up. Utilise planning tools such as the DRIVE toolkit.
4. Identify resource implications for individual studies and the portfolio of studies within the specialty. 
5. Ensure research equipment is maintained in an effective working and good clinical order.