New Product Development jobs in United States

hVIVO are currently seeking Bank Study Physician for our team in our screening site in Manchester.

hVIVOis 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

You will provide screening and assessment of subjects throughout their participation in the clinical trial screening process ensuring all assessments and procedures are carried out and documented in accordance with ICH GCP.

We currently require a commitment for around 20-30 hours per week Monday Friday 0900-1700.

Some travel to our London sites may be required for the initial months of training

Clinical Procedures

• Perform clinical procedures as required within protocol, and competence
• Supervise and review clinical procedures as performed by other clinical staff for eligibility and clinical condition changes
• Perform informed consent procedures ensuring maintenance of ICH GCP standards throughout
• Provide clinical support and expertise to clinical staff in the unit
• Identify service improvement areas and work with seniors to maintain and improve standards within the clinical area

Study Management

• Assist the Senior Study Physician and/or Sub-Investigator in staffing requirements and input in overall scheduling of staff
• Review and input into study protocols for logistical and medical feasibility as requested by senior research nurse
• Attend internal study specific training
• Recording of subject information into the source documentation and/or CRF as per study requirements

Volunteer Management

• Ensures informed consent procedures with the subject prior to the subject undergoing any procedures
• Ensures that documentation of informed consent procedure is recorded in each subject’s source documentation
• Ensures that subjects who are enrolled into research studies are eligible
• Collects subject medical history and medication usage
• Updates subject tracking forms and hVIVO databases as appropriate
• Maintains clear professional boundaries with subjects
• Liaise with cross divisional teams to ensure that sample requirements and timelines are met
• Safe discharge of subjects from the study, including documentation to the Subjects GP
• Escalation of any medical issues to senior medical team
• Provision of out of hours emergency cover as required

• Full GMC registration
• Medical Degree
• Current ALS certification
• Fluency in English
• Experience working within the UK healthcare structure
• Phlebotomy/Cannulation skills
• Previous experience of post-graduation experience e.g. internal medicine, general practice, A&E, Respiratory Medicine, Infectious Disease