Detailed job description and main responsibilities

Leadership

1. To assist the Lead Research Nurse / Practitioner to ensure the operational delivery of the clinical research team work plan, particularly with respect to achieving NIHR targets.

2. Manage research performance in relation to team activities and study timelines and targets set by R&D and the SWPCRN.

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 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, Research Assistant Practitioner, Research HCA, 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.

9. Lead in the recruitment of Senior Research Nurses/Practitioners within the relevant team.

10. 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.

 11. Oversee 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, and Standard Operating Procedures (SOPs).

13.  Facilitate and maintain effective communication within the research team and between the multidisciplinary clinical team.

14.  Represent the clinical research team and Plymouth Hospitals NHS Trust at a regional and national level.

15. Work as part of the clinical trials core operational team and contribute to the on-going development of the R&D department.

16.  Deputise for the Lead Research Nurse / Practitioner and provide cover for other Team Leads when required.

17.  Promote a blame free culture in reporting incidents and where appropriate initiating a local investigation in a timely manner.

18. Resolve relevant complaints and issues at a local level in partnership with patients, carers and their family and other healthcare professionals.

 19. Support appropriate studies within PHNT/UHP and its partner organisations as appropriate.

 Research

 1. Lead the management and delivery of a large clinical trial portfolio relevant to the Division/s 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.  Lead the Expression of Interest / Study Selection process for the Division. 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/Practitioner to resolve resource implications in delivering and facilitating clinical research.

5.  Monitor and plan in advance the research workload within the department and manage team performance.

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 PI for suitable studies and promote the non-medic PI role.

9.  Decide and delegate roles for the clinical research team in terms of study delivery, using the right skill mix for the study complexity.

10. Oversee the coordination of study visits including off site visits and ensure the team adhere to the lone worker policy.

11. 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 ensure and safety of patients within clinical trials.

12. Ensure both accurate costing for clinical trials and appropriate negotiation of required financial support to deliver clinical trials.

13. Ensure clear, accurate and concise records are kept for research projects in accordance with all regulatory requirements including the Data Protection Act.

14.  Oversee the maintenance of Trial Master Files and essential documents.

15. 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.

16. Ensure that the team record and report adverse and serious adverse events that occur whilst the participant is in the clinical trial to the trial co-coordinator/ PI and R&D office in line with the study protocol, local policies and regulatory requirements.

17. 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 Local Patient Management System is updated with key trial data and validated efficiently.

18. Promote collaborative working across the network and with other clinical researchers, within the CRN and NIHR structure.

19. 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.

20. 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.

21. Co-operate with external and internal audit, data monitoring and quality assurance by working with R&D, sponsors, study monitors and external bodies.

22. Promoting Innovation;- participate in the preparation of results of research for presentation as posters, abstracts, papers or scientific presentations.

 Clinical & Professional

 1.  Be highly visible in the clinical area, working alongside and supporting staff in a managerial and clinical capacity.

2.  Act as a specialist resource and role model for all aspects of research clinical practice in order to optimise patient care.

3.  Undertake all mandatory training and ensure that the clinical workforce is up to date with mandatory training.

4.  Ensure the environment is suitable for patient care and research processes, recognising the importance of privacy, dignity and diversity.

5.  Review incident reports related to the relevant area, carrying out investigations and taking appropriate action where required.

6.  Demonstrate professional development and an in-depth knowledge of current clinical and research practice and encourage and ensure the development of others.

7.  Provide on-going specialised advice and information to patients and their carers/families with regard to participation in clinical research.

8.  Where appropriate receive and document written informed consent from research subjects and act as an expert resource in informed consent.

9.  Ensure the safe and accurate collection of clinical research data such as venepuncture, history taking, standard observations (height weight, BP, temperature, heart rate) and other assessments such as ECG, physical examinations, disease specific outcome measures, questionnaires, rated scales and qualitative interviewing as required by the protocol through clinical supervision of the research team.

10.  Ensure staff competency to centrifuge, process track and ship samples in line with protocol requirements.

11.  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.

12.  Support the research team to monitor treatment toxicity/side effects and initiate changes to care as required by the protocol, escalating issues to the Principle Investigator where required.

13.  Ensure accurate patient trial documentation, including the use of electronic data capture systems and ensure relevant information is recorded in patients’ medical notes.

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 identify action plans to address any areas of concerns. Work with the Trust Lead Nurse for Patient Safety and Risk where there are persistent problems.

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. 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.

18. Ensure the on-going registration of clinical staff with relevant professional bodies.

19. Proactively seek feedback from participants and their families during their research involvement.