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., 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. Clinical and communication responsibilities
• Manage a caseload of Haematology clinical trial participants acting as a professional in ensuring a duty of care to the participant and their families.
• Work within relevant regulations and ICH GCP (International Conference on Harmonisation and Good Clinical Practice) ensuring that the clinical trial protocol is adhered to at all times.
• Devise, implement and evaluate strategies for identifying eligible participants for research studies, including by attending clinics, departments, screening notes/consultant referral and Multidisciplinary Team (MDT) meetings.
• Participate in the informed consent process acting as a resource and support to participants and their families. For appropriate studies take informed consent and ensure on-going consent.
• Co- ordinate the research participant pathway from screening through to study closure.
• Maintain adequate participant records and ensure all relevant information is documented in the medical electronic notes or relevant clinical information systems and communicated with clinical teams.
• Report any adverse events or health concerns which occur whilst the participant is taking part in the study to the appropriate doctor or nurse in a timely manner, and to the appropriate principal or co-investigator.
• Undertake a range of clinical tasks in line with personal competencies and as stipulated in approved study protocols such as blood pressure, temperature, respirations, questionnaires, urinalysis, weight and height, and report abnormalities or changes appropriately.
• Perform tasks requiring clinical and laboratory skills, including phlebotomy, venepuncture, biological sample preparation within clinical area and laboratories as stipulated in approved protocols and laboratory manuals as required.
• Responsible for safe tracking, storage, efficient transport and robust documentation of participants samples.
• Liaise with the clinical team to organise and ensure that study specific investigations are undertaken according to the protocol, obtain and document the results.
• Report any side effects or adverse events according to protocol guidelines and within the required timeframe.
• Act as a patient advocate.
• Report any deviation from normal practice to senior staff and agree changes in care programme.
• Deal with concerns raised by participants and visitors in a proactive manner and take remedial action as necessary.
• Report to the senior clinical research staff any clinical incidences. Assist in managing incidents, accidents and complaints in accordance with Trust Policies.
• Manage clinical incidents effectively.
Research and Portfolio Management
• 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.
• Ensure that all study documentation is effectively archived as required.
• Assist in the provision of information to allow for invoices to be raised for payments where appropriate.
• Create and maintain invoice tracking for each study in conjunction with clinical team, according to team processes as required.
• Build strong professional relationships with other departments in order to promote a good working environment integration of research and open channels of communication.
• Educate appropriate medical and nursing personnel and departments on portfolio of research studies and protocol specific requirements.
• Maintain a dialogue of progress with the Clinical Research Matron, Research Manager and research team leads.
• Participate in the presentation of research findings within the Trust research network.
• Provide cover when necessary for annual leave, study leave, sick leave.
Management and Leadership
• Provide specialist advice and training to colleagues as relevant to your role.
• Supervise, train or mentor new or more junior staff as required.
• Ensure implementation of policies and highlight changes where needed.
• Proactively make recommendations to improve the quality of service delivery.
• Report incidents in line with Trust processes and support team leaders in investigating and resolving issues.
• Act up for team leader as required.
• Act as a role model for excellence in research delivery.
• Take active role in department training programme.
• Assist with the preparation of posters/research papers for meetings, conferences or publications.
• Represent the research team at local, national and international forums.
• Participate and attend investigator meetings and conferences when required.
Education & Professional Development
• Take responsibility for identifying personal training and educational needs within the context of the service and those identified during the appraisal process.
• Contribute to updating, developing and implementing Standard Operating Procedures (SOPs).
• Act in accordance with Health Education England (HEE) Care Certificate framework standards at all times.
• Undertake an Individual Performance Review annually with your Line Manager.
• Maintain a record to reflect any training carried out pertaining to the post and ensure direct reports maintain training files.
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 R&D, NIHR Guy's and St Thomas' BRC and wider Trust to facilitate the achievement of objectives and shared learning.
  
  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.