Job Description

An exciting opportunity has arisen for you to join us as a Senior Clinical Research Practitioner. We are looking for an enthusiastic and motivated individual who is keen to develop their research experience. This is a great opportunity for the successful applicant to be part of the largest surgical trial in the UK and to expand their professional network both within the Trust and nationally.



Funded through the Birmingham trials unit, the post holder will be working to support multiple hospital sites which will be opening and recruiting patients (participants) to the ROSSINI-Platform trial throughout the UK. They will need to drive and support the recruitment and roll out of the ROSSINI-Platform trial with the responsibility for delivering high quality research and clinical care within an innovative, multi arm multi stage (MAMS) trial.



Based at the University Hospital of Wales within the Research Delivery team, the post holder will support the work of the Major Lower Limb Amputations (MLLA) Pillar and will link closely with the Lead Consultant for the pillar Mr David Bosanquet as well as the trials team in Birmingham.



If you would like to hear more about this role, please contact gail.williams7@wales.nhs.uk for information.



This post is fixed term/secondment for 12 months due to meet the needs of the service. If you are interested in applying for the secondment position, you must obtain permission from your current line manager prior to applying for this post.



The post holder will be working across hospital sites which will be opening and recruiting patients(participants) to the ROSSINI-Platform trial in the UK. They will need to drive and support the recruitment and roll out of the ROSSINI-Platform trial with the responsibility for delivering high quality research and clinical care within an innovative, multi arm multi stage (MAMS) trial. The post holder will:



Review trial documentation;

Support trial uptake;

Support hospital sites in the UK to open including training and compliance;

Dissemination of best practice:

pathways, recruitment and use of the digital wound hub;

Engagement with trainee-centric research collaboratives including training, obtaining GCP, maintaining site delegation logs;

Attending and contributing to the running of the trial through attendance and contribution to the pillar Trial Management Group and the Executive Trial Management Group:

Improving the interface between sites.

This role will be clinical and managerial and the post holder will be required to effectively manage their time to fulfil key responsibilities such as reviewing protocols, identifying resource implications, participating in meetings, proposing actions for poor recruiting sites, training, supporting and mentoring other members of staff, including those at other sites, whilst autonomously managing a caseload of participants. The post holder will be responsible for ensuring excellence in research delivery and participant experience.



Cardiff and Vale University Health Board is one of the largest Integrated Health Boards in the UK, employing over 17,000 staff, providing over 100 specialist services. Working across 6 hospital sites, we have a diverse range of career opportunities to offer. Serving over 500,000 people living in Cardiff and the Vale, we are focussed on the health and care needs of our local population whilst working with our partners to develop regional services. Together we are committed to improving health outcomes for everyone, delivering excellent care and support.



Our mission is "Living Well, Caring Well, Working Together", and our vision is that every person's chance of leading a healthy life should be equal. Our 10-year transformation and improvement strategy, Shaping Our Future Wellbeing, is our chance to work collaboratively with the public and our workforce to make our health board more sustainable for the future.



Clinical and Communication Responsibilities



Work autonomously to manage a large caseload of participants acting as a professional in ensuring a duty of care to the participants and their families.



Work within relevant regulations and ICH GCP (International Conference on Harmonisation and Good Clinical Practice) ensuring that the clinical research protocol is adhered to at all times.



Devise, implement and evaluate strategies to identify eligible participants for the ROSSINI-Platform, including attending appropriate clinical meetings, disseminating knowledge and awareness of the trial amongst peers and relevant parties nationally. Support multiple sites to implement those strategies.



Participate in the informed consent process acting as a resource and support to both sites and participants and their families.



Participate and support co-ordination of the relevant patient participation groups. Review and act on or feedback to the pillar and core teams relevant feedback from groups.



Coordinate the research participant pathway from screening for recruitment through to study closure.



Actively work to achieve study site and patient recruitment targets including engaging with the research team and site clinical teams to overcome barriers to participant enrolment. Provide motivational support to encourage recruitment to the ROSSINI-Platform.



Liaise with the clinical team to organise and ensure that study specific investigations are undertaken according to the protocol, obtain and document the results.



Deal with concerns raised by participants and visitors in a proactive manner and take appropriate remedial action as necessary.



Responsible for accurate and timely completion of Clinical Report Forms (CRFs) and for ensuring that all data queries are dealt with in a timely and efficient manner.



Communicate and liaise with the central trial team to support reporting and information collection requirements.



Report to the pillar and central governance teams any clinical incidences and follow up to conclusion.



Act as a role model for excellence in research delivery.



Portfolio Management and Development



Review study protocols and identify resource implications for the sites.



Liaise with the medical team/sponsor organisation and co-ordinate follow up of participant where necessary.



Liaise with sites to ensure all site trial set-up actions have been completed.



Process amendments and disseminate information to sites.



Ensure participant recruitment data is being collected in a timely and accurate manner across sites.



Build strong professional relationships with other sites and BCTU to promote a good working environment and foster collaboration



Educate appropriate medical and nursing personnel and departments of the ROSSINI-Platform and protocol specific requirements.



Participate in the presentation of research findings and represent the ROSSINI-platform within Cardiff and Vale UHB and Wales in collaboration with Health and Care Research Wales, across sites and in relevant national specialty forum.



Monitor patient recruitment and data collection week by week, reviewing local and national recruitment figures and alerting the lead research staff and Principal Investigators to any problems with recruitment.



Provide a monthly report of study activity and dissemination activity and other core information requirements for the central team.



Team Management and Leadership



Act as a role model for excellence in research delivery



Lead and support the team acting as an expert resource, demonstrating tenacity, drive, professional integrity, balance and perspective.



Implement and work within the Trust's HR policies on all staffing matters, including sickness, capability and disciplinary issues. Take corrective measures if indicated in liaison with Human Resources and the Management Team.



Be aware of all Trust procedures and policies and collaborate with other health care professionals to ensure that these are observed.



Innovate and contribute to the development of Network wide clinical and research policies and procedures.



Maintain the high profile of Cardiff & Vale UHB Research and Development and the ROSSINI-platform.



Work with the management team to ensure that Cardiff and Vale UHB is meeting the accrual targets for the ROSINI-Platform and act to address any shortfalls.



Attend and contribute to central team meetings to include research practitioner meetings and eTMGs.



Implement strategies and systems for quality assurance and actively contribute to internal and external audits and inspections



Attend investigator meetings and conferences when required acting as an ambassador for the ROSSINI-platform and the Trust.



Education and Professional Development



Attend the training programmes and other relevant education and training days as agreed in your development plan.



Act in accordance with care certificate framework standards at all times.



Take personal responsibility for own professional growth and keep up to date with professional development and research.



Maintain a record to reflect any training carried out pertaining to the post and ensure direct reports maintain training files.



Prepare posters/research papers for meetings, conferences and publications



Mentor and support other members of the team.



Other responsibilities



Act always in a manner which, promotes positive working relationships and maintains the professional image of the Trust.



Responsibly manage the control of equipment, resources and stock through the adherence of research policies and clinical trials budgets.



Actively seek to develop the role to take account of changing requirements of the service



Implement and adhere to relevant regulatory requirements related to study conduct.



Work collaboratively with colleagues across the Trust and the ROSSINI-platform to facilitate the achievement of objectives and shared learning.



You will be able to find a full Job description and Person Specification attached within the supporting documents or please click "Apply now" to view in Trac.