Clinical Research Practitioner
1 week ago
We're looking for a full time Band 5 Clinical Research Practitioner to coordinate and deliver clinical research studies at The Christie NHS Foundation Trust.
We are looking for a highly motivated and enthusiastic individual who can contribute to the development of clinical research for people with cancer within the Breast Research Team.
We have an extensive portfolio of trials, NIHR academic and commercial clinical trials. The role of the CRP will involve recruiting patients to these clinical trials, obtaining informed consent where appropriate, supporting patients enrolled in clinical trials, and ensuring study interventions are completed according to Good Clinical Practice (GCP) and Trust standards.
You will be working within a supportive team of experienced clinical research nurses and the clinical trial administration team.
The post will involve coordinating a portfolio of research studies across different specialties within the Trust and is ideal for individuals with an interest in Breast and experience of working in a busy clinical / research environment who wish to further develop their skills and experience.
The Christie is one of Europe’s leading cancer centres, treating over 60,000 patients a year. We are based in Manchester and serve a population of 3.2 million across Greater Manchester & Cheshire, but as a national specialist around 15% patients are referred to us from other parts of the country.
We provide radiotherapy through one of the largest radiotherapy departments in the world; chemotherapy on site and through 14 other hospitals; highly specialist surgery for complex and rare cancer; and a wide range of support and diagnostic services. We are also an international leader in research, with world first breakthroughs for over 100 years.
We run one of the largest early clinical trial units in Europe with over 300 trials every year. Cancer research in Manchester, most of which is undertaken on the Christie site, has been officially ranked the best in the UK.
DUTIES AND RESPONSIBILITIES
The specific responsibilities will depend on the requirements of each team, but may include:
Management
- Provide induction support and training to new and existing clinical trials staff, including development of training sessions and guidance documents.
- Encourage the sharing of best practice and dissemination of information through regular structured meetings with all trials administration staff.
- Assist with metric tracking for performance indicators including mandatory training requirements, divisional key performance indicators (i.e. time to recruiting first patient from NHS permission, patient recruitment to time and target), amendment timelines and divisional absences.
Clinical Research Co-ordination/ Data Management
- Interview, recruit, take informed consent and support patients and carers in non-treatment clinical trials/studies. This involves educating patients on the trials involved, explaining the advantages and disadvantages of taking part in non-treatment trials, whilst remaining unbiased at all times. Assess patients as required by trial protocols.
- Maintain adequate patient records and ensure all relevant information is documented in the patient’s medical and nursing notes.
- Provide continuity of care for patients and their carers throughout the trial programme. Provide non-clinical advice and support as appropriate. Ensure the provision of optimal patient care by alerting appropriate clinical colleagues when referral to other members of the MDT may be required.
- Act as a key point of contact with the R&D core team, study sponsors, clinical research organisations and specific research teams.
- Co-ordinate feasibility activities for new studies under direction from Clinical research Nurse Team Leaders and Principal Investigators
- Manage the set up and initiation of allocated clinical trials within assigned Clinical
- research Teams.
- Understand and deliver protocols in accordance with regulatory requirements
- Financial management of study set-up costs and income recovery for assigned clinical trials in conjunction with the R&D Business Planning and Finance teams with oversight from the Clinical Research Nurse Team Leaders/ Senior Clinical Research Nurses.
- Oversee maintenance of investigator site files and essential documentation in accordance with ICH-GCP and Trust Standard Operating Procedures (SOPs) to ensure they are kept inspection ready at all times.
- Assist with preparation for audit and inspections within assigned teams and implementation of action plans.
- Understand the process for obtaining NHS permissions (R&D approval) for conducting clinical trials at site. As project lead, ensure permissions are in place prior to any patient recruitment.
- Ensure all clinical trial activities are recorded in appropriate systems in a timely manner.
- Awareness of trial specific, regional and national targets. Identify and implement strategies for recruiting patients to clinical trials ens
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