Clinical Project Co-Ordinator

Overview:

hVIVO are seeking a Project Co-Ordinator to join the clinical team on a permanent basis at our site in London E1.

hVIVO conducts human challenge clinical trials. The end goal of our clinical trials is to potentially eradicate common illnesses like the common cold and flu completely – or at least make treatment of them as easy and effective as possible. Our studies focus on testing new treatments on real people, in a safe, controlled, clinical environment.

The Project Co-ordinator ensures that all delegated clinical and project management staff, work on our studies in accordance with regulatory standards and Company policies and procedures for optimal study delivery from project start-up to close.

Main Responsibilities:

• Creates and maintains records of study training and delegated tasks for all staff
• Supports the Clinical Study Leads (CSL) on the delivery of studies at site level
• Supports CSLs to set up, maintain, review and archive Investigator Site Files
• Provide requested ISF documentation
• Draft, maintain and close study delegation logs as live documents
• Support with external and internal audits
• Support the maintenance and update of internal and external study trackers.
• Maintain and update internal staff credentials
• Triangulate rota and staff resourced on duty with study activity at site to ensure that all staff are correctly delegated

Skills & Experiences:

• Demonstrable experience with clinical research study co-ordination/Management
• GCP certification and demonstrable competence in GCP application to study set up and co-ordination
• Excellent communicator
• Qualification in project management desirable