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.
Key responsibilities include:
- Review trial documentation
- Support trial uptake
- Support hospital sites in the UK to open, including training and compliance
- Disseminate best practice: pathways, recruitment and use of the digital wound hub
- Engage with trainee‑centric research collaboratives, including training, obtaining GCP, and maintaining site delegation logs
- Attend and contribute to the running of the trial through the Trial Management Group and the Executive Trial Management Group
- Improve the interface between sites
- Manage a large caseload of participants, ensuring a duty of care to participants and their families
- Work within relevant regulations and ICH GCP ensuring that the clinical research protocol is adhered to at all times
- Devise, implement and evaluate strategies to identify eligible participants, including attending appropriate clinical meetings and disseminating knowledge and awareness of the trial amongst peers and relevant parties nationally
- Participate in the informed consent process, acting as a resource and support to both sites and participants
- Coordinate the research participant pathway from screening for recruitment through to study closure
- Actively work to achieve study site and patient recruitment targets, providing motivational support to encourage recruitment
- Liaise with the clinical team to organise and ensure that study‑specific investigations are undertaken according to the protocol and to obtain and document results
- Deal with concerns raised by participants and visitors proactively, taking appropriate remedial action
- Ensure accurate and timely completion of Clinical Report Forms (CRFs) and resolve all data queries efficiently
- 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 them 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 coordinate follow‑up of participants where necessary
- 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, Wales and across national specialty forums
- 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 as an expert resource, demonstrating tenacity, drive, professional integrity, balance and perspective
- Implement and work within the Trust's HR policies on staffing matters, including sickness, capability and disciplinary issues
- 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 ROSSINI‑Platform and address any shortfalls
- Attend and contribute to central team meetings, including 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 as an ambassador for the ROSSINI‑Platform and the Trust
Education and Professional Development
- Attend 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 of 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 in a manner that 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
Managing Your Application
We are committed to promoting inclusion, where all staff have a sense of belonging. We welcome applications from everyone and recognise the need for our workforce to represent the diversity of the population we serve. We value our differences and fully advocate, cultivate and support an inclusive working environment where staff treat one another with dignity and respect and where diversity is celebrated.
Applicants are invited to apply in Welsh. Any application submitted in Welsh will not be treated less favourably than an application made in English.
The UHB reserves the right to close this vacancy after 24 hours if a large number of suitable applications are received. Therefore, we encourage early applications to ensure consideration for this post.
Successful applicants will receive all recruitment‑related correspondence via the email account registered on the application form.
To work in the UK, all candidates who are not UK or Republic of Ireland nationals require sponsorship to obtain either a Health and Care visa or Skilled Worker visa, unless you have permission to work via another route. Non‑UK / RoI candidates wishing to apply should self‑assess the likelihood of obtaining a Certificate of Sponsorship by visiting Work in the UK. If you are eligible for the Health and Care visa, application costs are lower and you do not need to pay the annual Immigration Health Surcharge.
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.