Clinical Research Practitioner II

The post holder will be expected to manage a caseload of participants in a portfolio of haematology clinical research studies. They will have duty of care in supporting them and their families throughout their participation in any research activity, acting as the participants advocate at all times.

The role will include identifying suitable patients for clinical trials and to work autonomously within professional practice guidelines and within the Research Governance Framework. The post holder may need to work flexibly across disciplines to ensure the successful working of the clinical research projects they are assigned to.

Drawing on knowledge and experience they will supervise and mentor other staff and actively contribute to evaluation and improvement of the service.

The post holder will play a key role in ensuring that any research undertaken within the department safeguards the wellbeing of the patients and is conducted according to Good Clinical Practice (GCP) and the Medicines for Human Use (Clinical Trial) Regulations 2004 and Amended Regulations 2006. In conjunction with the other members of the team, they will facilitate the production of good quality of research.

• Manage portfolio of Haematology clinical Trials (Phase I – III commercial and No-commercial).
• Assist in the review of research study protocols and identify resource implications for the site.
• Liaise with study set-up teams to facilitate smooth and effective study set-up.
• Assist in completing submissions to Research & Development departments.
• Process amendments and disseminate information to relevant departments.
• Participate in the collation of data, including performance data.
• 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.
• Ensure timely information and reports to reflect recruitment of patients including timely entry to EDGE according to team processes.
• Actively work to achieve study accrual targets including engaging with the research team and clinical teams to overcome barriers to participant enrolment.
• Monitor patient recruitment and data collection week by week, reviewing recruitment figures and alerting the lead research staff and Principal Investigators to any problems with recruitment.
• Organise and facilitate Sponsor meetings and visits, including site initiation, monitoring and close-out, representing the Trust in a professional and positive manner.

Guy’s and St Thomas’ NHS Foundation Trust comprises five of the UK’s best known hospitals – Guy’s, St Thomas’, Evelina London Children’s Hospital, Royal Brompton and Harefield – as well as community services in Lambeth and Southwark, all with a long history of high quality care, clinical excellence, research and innovation.

We are among the UK’s busiest, most successful foundation trusts. We provide specialist care for patients including heart and lung, cancer and renal services as well as a full range of local hospital and community services for people in Lambeth and Southwark.

We have a long tradition of clinical and scientific achievement and – as part of King’s Health Partners – we are one of England’s eight academic health sciences centres, bringing together world-class clinical services, teaching and research. We have one of the National Institute for Health Research’s biomedical research centres, established with King’s College London in 2007, as well as dedicated clinical research facilities.

We have around 22,700 staff, making us one of the largest NHS Trusts in the country and one of the biggest employers locally.

For further details / informal visits contact: Name: Thompson Olaoni Job title: Team Lead Haematology Clinical Trials Email address: thompson.olaoni@nhs.net Telephone number: 02071881425