Clinical Trials Coordinator
2 weeks ago
University Hospital Southampton NHS Foundation Trust is seeking a skilled Clinical Research Nurse/Midwife to join our team.
Job SummaryAs a Clinical Research Nurse/Midwife, you will play a crucial role in supporting the delivery of high-quality research studies at our trust. Your primary responsibility will be to manage, coordinate, and implement the PICNIC study across 3 UK sites, ensuring compliance with regulatory requirements and Good Clinical Practice guidelines.
Key Responsibilities:
- Support trial set-up in collaboration with the Chief Investigator, Project Manager, and other relevant personnel.
- Ensure regulatory requirements are fulfilled and all necessary approvals and authorizations are in place for UK sites.
- Take responsibility for applications and assist participating investigators with local study requirements.
- Monitor trial conduct to ensure protocol compliance, good patient management, and adherence to Good Clinical Practice guidelines.
- Communicate and promote the trial to ensure wide participation and good accrual of participants.
- Prepare and submit trial progress reports as required, including reports for trial funders and the Research Ethics Committee.
The ideal candidate will have extensive post-registration experience in clinical research or a relevant clinical specialty, with a strong understanding of the UK Policy Framework for Health and Social Care and International Conference on Harmonisation/Good Clinical Practice (ICH/GCP). A degree in healthcare or biomedical science is also essential.
RequirementsEssential Qualifications:
- Registered Nurse or Statutory Registered Allied Health Professional on the relevant part of the NMC/HCPC register.
- Evidence of ongoing professional and academic development.
- Mentorship qualification or evidence of meeting the NMC standards.
- Degree in healthcare or biomedical science.
Desirable Experience:
- Clinical research experience.
- Experience as an NMC/HCPC sign-off mentor or clinical practice assessor.
- Experience of leading the delivery of a clinical research project.
- Experience of being a link nurse (e.g., infection prevention, manual handling, fire warden, etc.).
The successful candidate will be required to meet with the Chief Investigator and Project Manager to discuss the PICNIC study in detail.
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