Clinical Research Fellow

2 weeks ago

Oxford, United Kingdom Oxford Health NHS Foundation Trust Full time

We are looking for an enthusiastic and well-motivated Clinical Research Fellow with exceptional organisation and communication skills to lead the promotion, screening, recruitment, assessment and follow-up of SINAPPS2 trial participants at ten sites across the UK. The SINAPPS2 trial is a randomised double-blinded placebo controlled clinical trial of investigational medicinal products testing the efficacy and safety of immunotherapy (IVIG and rituximab) in people with acute psychosis and anti-neuronal membrane antibodies. The post would suit someone in psychiatry or neurology training who wishes to gain experience in clinical trials as a step towards a clinical academic career.

1. Proactively promote the clinical trial and screening study across participating NHS Trusts across the UK and develop and foster links with various stakeholders in order to facilitate the recruitment of participants, including identifying eligible patients
2. Support study delivery by undertaking research activities outlined in approved study documents; facilitate the informed consent process as per legislation and the Mental Capacity Act, develop and maintain skills, experience and competence in administering rating scales, and conduct assessments with study participants
3. Build effective working relationships with clinical teams and university staff (psychiatry and neurology)
4. Closely collaborate with the trial multi-disciplinary trial team of researchers and clinicians. The post holder will be geographically embedded within the trial site in Oxford but will be expected to travel to other sites across the UK
5. Communicate effectively with all stakeholders, internal and external, involved in the research project.
6. Attend designated Clinical Research Facility clinics or outpatient neurology and psychiatric clinics to assess study participants and provide flexible support to local research and clinical staff
7. Provide clinical and research staff and participants with information about the studies, the rationale for their selection and the consequences of participating
8. Develop sound relationships with participants based upon respect and an understanding of mental capacity and consent to participate in research
9. Ensure that participants have good support mechanisms before, during and following their participation in the research study
10. Demonstrate an understanding of the factors that affect recruitment to a research study
11. Collect and maintain data and study documentation (including site files) in a systematic manner
12. Ensure accurate data entry, and that all data collected is stored and used in compliance with relevant statutory instruments, national and local guidelines and regulations
13. Provide written reports, both written and verbal, to all the trial participants and clinical and research teams regarding the progress of the research
14. Undertake research activities using sound research ethics principles and adhere to Good Clinical Practice (ICH-GCP), Research Governance Framework, national and local practices and policies
15. Support the management team in the event of inspection from a regulatory and/or monitoring authority
16. Engage in multi-disciplinary meetings, trial teleconferences, presentations of research to clinical teams, researchers and at conferences
17. Meet with Line Manager for supervision to ensure the research project is developed according to the project plan and conducted in a legal and ethical manner
18. Assist with the analysis and write-up of the research using statistical procedures, statistical software (e.g. SPSS, STATA) and other information technology and software (including word-processing, spreadsheet and databases) as appropriate.
19. Other tasks on an ad hoc basis relating to the research as required

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