For every trial adopting Site Nurse Support a Project Manager (PM) and a Nurse Manager (NM) are assigned. The Project Manager is responsible for the set up and conduct of the services across all countries; based at our head office in the UK or our North American office, the Project Manager is the primary point of contact for the Sponsor and/or CRO team.
All activities and visits are tracked, scheduled and reported by a dedicated Project Manager, with standard and customizable reports provided and regular meetings held to ensure complete transparency.
Site Nurse Support projects can be unpredictable and both the resourcing and management needs to remain dynamic throughout; not all sites will want outside resource as the volume of work is unpredictable and the number of patients per site is unknown. All these factors need to be considered as the project evolves and be reported and discussed with the sponsor/CRO on an ongoing basis.
How is quality maintained?
All of our site support nurses and study site coordinators (SSCs) are selected and trained specifically per project; this ensures that they are placed on site with the right skills and experience to do their job. All of our nurses receive regular ICH GCP and competency training to ensure their knowledge base is kept up to date.
Day to day the nurses and study site co-ordinators report into the PI and work as part of their healthcare team, but they also report into an MRN Project Manager who has oversight of the work they are completing. Where teams are covering multiple sites across a study or a program, they will report progress and results on a per visit basis back to the Project Manager.
The Project Manager is responsible for checking the quality and productivity of the MRN teams and will conduct regular one to one reviews with the nurses and study site co-ordinators, as well as the PIs on site.
Site nursing projects are governed by MRN-COMPLY and its suite of documentation, providing a robust framework to meet regulations and ensure we deliver a quality product.