Overview
of the role
hVIVO is pioneering a human-based clinical trial platform to accelerate drug and vaccine development in respiratory and infectious diseases. Leveraging human disease models in flu, RSV, HRV and respiratory indications, the hVIVO platform captures disease in motion, illuminating the entire disease life cycle from healthy to sick and back to health. Our vision remains to become the partner of choice for companies developing products in airways disease that are seeking to gain early proof of concept around the effectiveness of their products and identify the ideal patient profile for later stage clinical development. hVIVO has established itself as the world leader in human challenge models
We are currently recruiting for a number of Bank Study Physicians for our team in London, who can be available for evening and weekend shifts.
You will provide screening and assessment of subjects throughout their participation in the clinical trial process ensuring all assessments and procedures are carried out and documented within the protocol requirements/SOP/OIs and according to ICH GCP, other statutory instruments and GMC requirements.
Please note, hVIVO works with a range of respiratory viruses as part of our day to day operation, including Covid-19. Your suitability will be part of the interview process from a health and safety perspective and it is recommended you consider your own health and those of family members (clinically vulnerable and shielding) when considering to apply for this role.
Main Responsibilities & duties
Clinical Procedures
1. Perform clinical procedures as required within protocol, and competence
2. Supervise and review clinical procedures as performed by other clinical staff for eligibility and clinical condition changes
3. Perform informed consent procedures ensuring maintenance of ICH GCP standards throughout
4. Provide clinical support and expertise to clinical staff in the unit
5. Identify service improvement areas and work with seniors to maintain and improve standards within the clinical area
Study Management
6. Assist the Senior Study Physician and/or Sub-Investigator in staffing requirements and input in overall scheduling of staff
7. Review and input into study protocols for logistical and medical feasibility as requested by senior research nurse
8. Attend internal study specific training
9. Recording of subject information into the source documentation and/or CRF as per study requirements
Volunteer Management
10. Ensures informed consent procedures with the subject prior to the subject undergoing any procedures
11. Ensures that documentation of informed consent procedure is recorded in each subject’s source documentation
12. Ensures that subjects who are enrolled into research studies are eligible
13. Collects subject medical history and medication usage
14. Updates subject tracking forms and hVIVO databases as appropriate
15. Maintains clear professional boundaries with subjects
16. Liaise with cross divisional teams to ensure that sample requirements and timelines are met
17. Safe discharge of subjects from the study, including documentation to the Subjects GP
18. Escalation of any medical issues to senior medical team
19. Provision of out of hours emergency cover as required
Skills & Experiences
20. Full GMC registration
21. Medical Degree
22. Current ALS certification
23. Fluency in English
24. Experience working within the UK healthcare structure
25. Phlebotomy/Cannulation skills
26. Previous experience of post-graduation experience e.g. internal medicine, general practice, A&E, Respiratory Medicine, Infectious Disease