Clinical Research Practitioner

4 weeks ago

Leeds, Leeds, United Kingdom Leeds Teaching Hospitals Full time

Job Summary

Leeds Teaching Hospitals is seeking a highly skilled and motivated individual to join our Diabetes and Endocrinology Research Team as a Research Nurse/Midwife/AHP. The successful candidate will contribute to the conduct, coordination, and delivery of our research portfolio, working closely with senior colleagues and members of the multidisciplinary team to deliver high-quality clinical care to patients participating in interventional and observational studies.

Main Duties and Responsibilities

  • Support the Senior Research Nurse/Midwife/AHP in providing leadership to the research team, ensuring standards are maintained and patient safety assured.
  • Work closely with industry partners, the National Institute for Health Research (NIHR) Clinical Research Network (CRN) Yorkshire and Humber, and colleagues in neighboring establishments, attending regional and national meetings as required.
  • Ensure that research undertaken within the department safeguards the wellbeing of patients and is conducted within the confines of ICH Good Clinical Practice Guidelines for Research, EU directive, UK Governance Framework, and other relevant UK legislation.
  • Coordinate and deliver a portfolio of clinical research studies, ensuring that participants receive high standards of patient-focused care in accordance with Leeds Teaching Hospitals Trust guidelines and policies.
  • Provide on-going advice and information to patients/volunteers with regard to their participation in clinical research, facilitating effective informed consent and maintaining a supportive role throughout the trial.
  • Assist in the assessment of patients/volunteers for eligibility for research and monitoring of their condition throughout their participation.
  • Liaise with representatives from pharmaceutical commercial companies and prepare data for monitoring by these representatives.
  • Accurately report and document Serious Adverse Events, or Reactions, to the relevant clinician, Sponsor, and authorities within the required timelines, ensuring any interventions or modifications are carried out.
  • Perform clinical tasks when required for research purposes, including venepuncture and central line access for Registered Nurse/Midwife.
  • Process, store, and despatch blood, urine, and other biological samples according to trial protocols and Trust policies and guidelines.
  • Assist other members of the team in providing 24-hour support and advice for Phase I, II, III, and pharmacokinetic studies.
  • Work as part of the multidisciplinary team and contribute to the on-going development of the department.
  • Take an active role in education and training of various groups with regard to specific trial requirements and clinical research in general.
  • Act in an advisory capacity for regional or national groups if required.
  • Fulfill the requirements as directed by the registration body the person in post belongs to (for example: Nursing and Midwifery Council or Health and Care Professions Council to maintain and revalidate registration).
  • Observe the confidentiality of patient information at all times, in accordance with the Data Protection Act and local information governance policy.
  • Be conversant with cardiac arrest, major incident, and fire procedures as they relate to your local clinical area and the wider Trust.
  • Be conversant with and adhere to all clinical protocols, local departmental, and Trust protocols.
  • Undertake duties on other wards or departments as and when required by service demands or patient need.
  • Act in such a way that safeguards the health and wellbeing of children and vulnerable adults at all times. Is familiar with and adheres to, the LTHT safeguarding policies.
  • Actively promote and use The Leeds Improvement Method to improve quality and safety of the service.
  • Maintain an active knowledge of the Trust's clinical and research IT systems (in particular EDGE) by actively supporting their use.
  • Ability to deal with highly complex, contentious, and sensitive information on a daily basis.
  • Provide and receive highly complex information.

Person Specification

  • Autonomy
  • Independence
  • Capable of lateral thinking
  • IT Skills
  • Time management
  • Excellent communication and interpersonal skills

Qualifications

  • Registered Nurse (Level 1 or 2) (RN Adult for adult areas and RN Child for children's areas), Midwife or HCPC AHP or Clinical Research Practitioner registered (including registration to AHCS)
  • Post-registration qualification in specialty

Experience

  • Significant post-registration experience
  • Experience of computer databases and administration
  • Knowledge of clinical research specific issues

Other Criteria

  • Able to fulfill Occupational Health requirements for post
  • Willing to undergo training as necessary
  • Recent professional development

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