What is a Research Nursing project Manager?
One unique role in clinical trial project management that you may not have heard of is that of the Research Nursing Project Manager; or a “RNPM”.
At Illingworth Research Group such a unique role is being utilised to deliver our projects through the coordination of patient centric “off-site” study visits. The RNPMs all have a nursing or a life sciences background, most are registered nurses and have significant experience in the operational delivery of both clinical trials and clinical care.
During the study set-up phase the RNPM will interview research nurses to ensure that appropriate resource is allocated to the project. They will identify the appropriate equipment, produce the study specific documentation required for the execution of the off-site visits and will train each nurse on how the protocol should be implemented. Where study sites identify a patient to be seen by an Illingworth Research Nurse, the RNPM will coordinate off-site visits with nurses located near to study participants, ensuring that training is complete, all visits are covered, couriers are booked and data is collected to GCP standards.
The work isn’t always 9 to 5 as the RNPMs manage global projects and ensure that support is available for nurses who see patients around the clock! This flexible service ensures that patient’s can continue with their normal routines, that visits are conducted to the protocol defined windows and it increases the recruitment and retention rates of clinical trials.
Click to Expand
The week usually starts off with a review of the study budget and approval of timesheets for nurses and other team members who have worked on the project over the previous week. I spend the rest of the morning incorporating client comments in to the off-site nursing manual; the documents that the research nurses will use when they are conducting visits in the patient’s homes. It takes some time to make sure that these are correct and properly reflect the study protocol and Illingworth processes and procedures.
In the afternoon I review a Request for a Proposal from a client who is looking for off-site nursing support for a trial which requires off-site administration of an intravenous infusion and multiple blood samples. I review lessons learned from previous similar projects and provide my suggestions to the Project Lead in the Business Development teams.
Nurse visits are scheduled for patients located in London and Germany today, last week I scheduled these with the various nurses and booked couriers to transport the study drug to the patient’s homes. The nurses keep me up to date with the progress of the visits throughout the day and when they have finished the visits they send me the completed worksheets. I check the documents for completion and quality and enter the data in to the study Electronic Data Capture (EDC) system.
I plan to be out of the office at the end of the week so I schedule future visits with the nurses and hand these over to the back-up RNPM who will follow these visits through with the nurses on Thursday and Friday.
I spend the afternoon on a call with 3 nurses in Romania, conducting study specific training and preparing them for their first off-site visits on this particular project. I collate training records, CVs, GCP certificates and provide all the required documentation to the study team and the Sites for filing in the Investigator Site File.
Every Wednesday morning I attend the study team meeting. Representatives attend this meeting from the Sponsor Team, the CRO Team and from all vendor teams. We cover the study status updates and focus in on the next big milestones, which for this study include plans for First Patient In in 3 sites that will go live in just a few weeks.
I spend the rest of the morning actioning items that were raised during the weekly project team meeting and communicating relevant updates to the internal Illingworth team.
In the afternoon I attend interviews for new nurses who have expressed an interest in working with Illingworth in Spain and Canada, the interviews go well as the nurses have a lot of research experience and good understanding of GCP.
This morning I rehearse the presentation that I will give to train study CRAs and Investigator Sites on how Illingworth Off-Site Services work and how we will work together on the new study. I prepare for being out of the office for the week and handover to the back-up RNPM with relevant study updates.
I spend the afternoon travelling to Barcelona for the Investigator Meeting, I leave home after lunch and arrive in Barcelona early evening.
Today I attend the all-day Investigator meeting in Barcelona, there are 20 CRAs and 40 Site representatives present, including Principle Investigators and Study Coordinators. We all receive information on the study protocol, the investigational product and the study procedures. My training presentation goes well and there is a lot of interest from the recipients, the majority of which have never worked with off-site nursing services previously. After the meeting I head back to the airport for my flight back to the UK, after a very long but enjoyable day I arrive home just before midnight!