Clinical Research Practitioner

3 weeks ago

East Midlands, United Kingdom North West Boroughs Healthcare NHS Foundation Trust Full time
Job Overview

We are seeking a highly skilled Clinical Research Practitioner to join our team at North West Boroughs Healthcare NHS Foundation Trust. The successful candidate will be responsible for delivering a portfolio of clinical research studies across the Trust footprint, working collaboratively with the Research and Development Manager, Study Principal Investigators, and other members of the research team.

The ideal candidate will have experience of working with research/clinical trials, possess good interpersonal and communication skills, and be able to work independently and as part of a team.

Main Duties of the Job

  1. Identify and recruit service users into clinical studies, acting as a source of information and support to service users and their relatives by explaining practical aspects of participating in clinical research.
  2. Ensure that each person fulfils the relevant study criteria and understands the implication of participation when taking informed consent.
  3. Demonstrate knowledge of the ethical principles for clinical research and its impact on current practice.
  4. Ensure ethical and clinical safe practice at all times.
  5. Ensure that each study is conducted in accordance with the study protocol, Trust Standard Operating Procedures, and relevant research legislation and guidance.
  6. Provide direct patient care within the scope of the study protocol, including (but not limited to) physical observations, ECGs, and phlebotomy where required.
  7. Process and ship blood and other samples as required in the study protocol, ensuring safe and appropriate storage and handling of specimens in line with Trust policy and IATA guidelines.
  8. Provide appropriate information and support concerning research, care, and treatment of individuals participating in research studies to any nursing and/or support staff involved in the participant's care.
  9. Liaise with Principal Investigators, support services (e.g., pharmacy, radiology, laboratories), study sponsors, clinical research associates, and other members of the study team, to ensure smooth running of the study.
  10. Provide research information to medical, nursing staff, service users, General Practitioners, community services, and other staff where appropriate.
  11. Take a proactive role to increase Trust participation in portfolio research and recruitment rates in individual studies.
  12. Responsible for timely, accurate, and complete documentation in the participants' care record and the study case report form (CRF) in accordance with Trust policy and regulations.
  13. Record and report adverse events, serious adverse events, and suspected, unexpected, serious adverse reactions (SUSARs) that may occur during the course of the study, to relevant personnel and act as defined within the study protocol and according to Trust policy and ICH-GCP recommendations.
  14. Assist with the coordination of study visits, in line with protocol window requirements.
  15. Assist with the set-up, undertaking, and close of each research study as required.
  16. Assist with the identification of strategies to recruit participants into research studies.
  17. Assist with identifying barriers to recruitment and ensure that the R&D Manager and Principal Investigators are aware where this has the potential to impact on study delivery targets.
  18. Ensure that all research documentation, including screening, recruitment, and regulatory records are complete and accurately maintained.
  19. Provide information to allow for invoices to be raised for payment where appropriate.
  20. Comply with organisational policy on documenting critical incidents and near misses and assist with root cause analysis and the implementation of changes in practice to reduce risk.
  21. Prepare for and participate in internal audits and inspections, evaluations, and benchmarking exercises.
  22. Prepare and make available study documentation for monitoring audits and inspections as required by the Trust and associated regulatory bodies.
  23. Ensure the requirements of other agencies such as the National Institute for Health Research and the Medicines and Healthcare Products Regulatory Agency are followed in order to meet research governance targets, improve clinical outcomes, and ensure compliance with all legislation or standards expected for research services.
  24. Monitor and provide information on research activity giving cause for concern.
  25. Act as a mentor and contribute towards the induction and orientation of junior colleagues within the department.
  26. Plan own diary in accordance with the requirements of the Trust research portfolio.
  27. Ensure an appropriate and adequate hand over during periods of leave.

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