Job summary
We have an exciting opportunity for someone who is interested in helping improve patient treatment outcomes for our oncology patients. The post offers an opportunity to join our enthusiastic and motivated Oncology Clinical Trials Team for the next 12 months.
The post holder will be required to recruit and monitor patients and manage the co-ordination of the trial protocols on a varied portfolio of oncology clinical trials as well as collect and accurately document the data.
This role would suit someone who has a flexible approach to working, is able to use their own initiative and has an interest in research.
For further information contact:
Rebecca Hick
Senior Research Nurse
01752 431957
Main duties of the job
The post holder will be responsible for the implementation and monitoring of the clinical requirements associated with research to ensure optimum delivery of clinical trials. S/he will ensure that all research procedures are conducted according to study protocols and will be accountable for the recruitment, data collection and care of research participants with a focus on providing a quality experience.
***Preference will be given to internal Trust staff, as well as 'Priority' and 'At Risk' status including NHS At Risk staff throughout Devon who are able to display recent relevant experience as dictated by the Person Specification.***
About us
We are a people business - where every member of staff matters and can make a difference. Patients are at the heart of everything we do. Joining University Hospitals Plymouth NHS Trust means becoming part of a team of dedicated staff, who are committed to leading the way through innovation, clinical excellence and great customer care. The Trust has great opportunities for career development in a highly progressive working environment. We offer all of this in a vibrant, modern city with a historic reputation for adventure. PLEASE NOTE THAT ALL COMMUNICATION WILL BE ELECTRONIC, PLEASE CHECK YOUR EMAIL ACCOUNT REGULARLY. If you have any issues with applying online and need additional support including reasonable adjustments with the application process please contact the recruitment team on 01752 432100. We recognise that work life balance is important for our colleagues and so we invite requests from applicants around less than full time/flexible working for our advertised roles. Please contact the recruiting manager to discuss this prior to your application submission. We commit to giving this full consideration in each case. We encourage people from diverse backgrounds to apply for our roles, as diversity strengthens our teams. It is sometimes necessary to close vacancies before the closing date. If you have not heard from us within 4 weeks of the closing date, please assume that you have not been shortlisted.
Job description
Job responsibilities
PRIMARY DUTIES & AREAS OF RESPONSIBILITY
Leadership
1. Have an understanding of the clinical research team work-plan and contribute to its achievement.
2. Manage research performance and study timelines of relevant studies.
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. Provide relevant supervision and mentorship to members of staff and students.
6. Take responsibility for own health, safety and security and promote the health, safety and security of the wider team.
7. Contribute to the development and implementation of clinical and research policies, procedures and SOPs.
8. Facilitate and maintain effective communication within the research team and between the multidisciplinary clinical team.
9. Assist in the delivery of education and training regarding research for the wider Multidisciplinary Team and act as an ambassador for research.
10. Promote a blame free culture in reporting incidents and where appropriate support local investigation of incidents.
11. Support appropriate studies within PHNT/UHP and its partner organisations as appropriate.
Research
1. Be responsible for the delivery of a clinical trial portfolio relevant to the specialty.
2. 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.
3. Participate in Good Clinical Practice (GCP) training.
4. Contribute to the Expression of Interest / Study Selection process for the relevant specialty.
5. Contribute to study set up, recruitment planning and study delivery.
6. Lead forward and contribute to Patient and Public involvement activities.
7. Be responsible for promoting the appropriate referral and recruitment of patients to clinical research studies. Work with the clinical trials team and investigators to develop strategies to overcome barriers to recruitment and to solve other problems relating to specific studies.
8. Coordinate and run study visits including off site visits whilst adhering to the lone worker policy.
9. 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.
10. Contribute to the accurate costing for clinical trials
11. Ensure clear, accurate and concise records are kept for research projects in accordance with all regulatory requirements including the Data Protection Act.
12. Ensure that data is transcribed accurately where required and assist with the maintenance of the Trial Master File.
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 any Data Management Systems are updated with key trial data and validated efficiently.
16. Escalate on-going study performance issues to the Senior Research Nurse or Team Lead.
17. Co-operate with external and internal audit, data monitoring and quality assurance by working with R&D, sponsors, study monitors and external bodies.
18. Assist in study close down and the preparation of results of research for presentation as posters, abstracts, papers or scientific presentations.
For further details please see attached JD&PS.
Person Specification
Qualifications
Essential
1. Registered Nurse or Healthcare Professional, currently registered with UK regulatory body NMC/HPC
Desirable
2. Research Training ( GCP, degree module, informed consent)
Knowledge and Expeirence
Essential
3. Pertinent clinical skills
4. Computer literacy including ability to work with databases.
5. Ability to organise and prioritise own workload and work to tight deadlines
6. Understand the significance of research and use of validated results to improve practice
7. Ability to communicate complex information to patients/carers/ members of MDT
8. Broad and recent clinical demonstrable experience relevant to the post
Desirable
9. Proven knowledge of the Research Governance Framework and Good Clinical Practice Guidelines
10. Proven knowledge of clinical trials & research methodologies
11. Demonstrable experience of clinical research within the NHS or commercial setting
12. Understanding of data collection and data entry for clinical trials
Aptitude and Abilities
Essential
13. Ability to work autonomously
14. Ability to work cohesively as a member of a multidisciplinary team