Senior Research Nurse/Practitioner

Job description

Job responsibilities

Please see attached full Job Description.

MAIN DUTIES/RESPONSIBILITIES

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 UK Policy Framework for Health and Social Care Research 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 Lead Research Practitioner 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 Lead Research Practitioners 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. Respond to data queries generated by the study coordinating team within a timely manner.

14. 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.

15. 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.

16. Identify and resolve study performance issues, escalating on-going issues to the Lead Research Practitioner where required.

17. Promote collaborative working across the network and with other clinical researchers, within the CRN and NIHR structure, and Plymouth area, such as UHP (University Hospital Plymouth).

18. 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.

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

20. The post holder will provide educational/teaching sessions as appropriate to all levels of staff, patients and carers thereby developing research awareness, culture and knowledge base by disseminating information about current studies, subsequent results and learning.

5.1 Responsibility for People Management

1. Responsible for the operational delivery of the clinical research team workplan 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 /Lead Research Practitioners 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 Lead Research Practitioners 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. Facilitate and maintain effective communication within the research team and between the multidisciplinary clinical team.

13. Promote a blame free culture in reporting incidents and where appropriate support local investigation of incidents.

14. Support appropriate studies within Livewell Southwest and its partner organisations as appropriate.

5.2 Responsibility for financial and/or physical resources

1. Lead the recruitment of new junior personnel and ensure that an appropriate and safe skill mix is maintained. Work with the Lead Research Practitioner 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 as available.

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.

5.3 Responsibility for administration - see JD

5.4 Responsibility for people who use our services - see JD

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, out-patients and using organisation IT systems and databases in accordance with protocol and information governance requirements.

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. ... continued in JD

5.5 Responsibility for implementation of policy and/or service developments - see JD

Person Specification

Skills

Essential

• Ability to work autonomously Willingness to learn, instigate and develop efficient working systems Ability to work cohesively as a member of a team Willingness to undertake any necessary training and development to enhance work performance Commitment to openness, honesty and integrity in undertaking the role Willingness and ability to work across sites including community. Attention to detail Evidence of ability to adapt communication methods, sensitively and professionally, to suit the needs of patients and service users

Desirable

• Management experience Project management experience

Experience

Essential

• Broad and recent clinical experience relevant to the post Proven experience of managing teams Ability to organise and prioritise own workload and work to tight deadlines Ability to make independent decisions Pertinent clinical skills Proven Management or Leadership experience

Desirable

• Line Management experience within the NHS/Livewell Experience of delivering commercial and academic research Experience of research within the NHS/Livewell setting Proven record of meeting participant recruitment targets

Additional Requirements

Essential

• Able to accommodate agile / hybrid working Ability to drive and/or use transport to visit patients and settings in Plymouth and surrounding areas Ability to work alone with patients in their homes, in accordance with the Lone Working Policy Ability to travel independently across the Southwest Peninsula when required. Demonstrate a passion to be fully research-active and act as a champion to promote a research culture throughout Livewell Southwest and amongst its service users.

Desirable

• A full UK driving licence

Knowledge

Essential

• Knowledge of the UK Policy Framework for Health and Social Care Research and Good Clinical Practice Guidelines IT skills including ability to work with databases Critical appraisal skills

Desirable

• Good leadership skills and proven managerial ability In-depth knowledge of clinical trials and research methodologies In-depth knowledge of data collection and data entry for clinical trials

Qualifications

Essential

• Registered Nurse or Healthcare Professional Relevant Healthcare Degree Mentorship experience/ qualification Proven Management/ Leadership experience or Qualification

Desirable

• Research methodology training Higher degree/study of research design /methodology in clinical or social care setting or equivalent Teaching qualification/ experience Research Training (e.g. GCP, degree module, or other including informed consent

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

UK Registration

Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window).

Employer details

Employer name

Livewell Southwest

Address

200 Mount Gould Road

Mount Gould

Plymouth

Devon

PL4 7PY

Employer's website

https://www.livewellsouthwest.co.uk/ (Opens in a new tab)