Passion for patients
Taking the trial to the patient
A short series of a week in the life of some of our key roles. Highlighting some of the different roles here at Illingworth, we have a range of unique and interesting roles for clinical professionals. We appreciate that our people are at the heart of all we do and continuing to innovate clinical trial delivery. We run an active recruitment program and are proud to offer comprehensive packages, training and opportunities for future development focused on attracting the best talent in the industry.
A week in the life of...
Usual week in the life of the Illingworth team
Research Nursing Project Manager
What is an RNPM?
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.
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.
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!
Research Nursing Project Coordinator
What is an RNPC?
As Research Nurse Project Coordinators (RNPCs) we assist the Research Nurse Project Managers in the day to day running of their research projects. The job is really in the title, ‘Project Coordinator’. We coordinate the smooth running of the project, from arranging “off-site” project visits with the Research Nurse (RN), to ensuring that the RN has all the equipment needed for that visit. It is a very diverse, busy role that comes with challenges, but we always have the patients’ best interest and safety at the forefront of our minds.
Our RNPCs typically are biomedical science graduates or have experience in the coordination of clinical research within the NHS.
Here is an example of a typical working week, showcasing a request to perform an offsite visit.
I like to start my day by checking the project tracker to see what visits occurred over the weekend. We quality check the worksheets that the RN has completed during the visit and they must be sent to the hospital site within ~48 working hours after the visit completion. This is a priority, and we usually quality check worksheets every morning from visits that occurred the day before.
After quality checking the project worksheets for the day, I normally look in the project inbox to see whether we have received any emails from sites requesting “off-site” study visits. These requests come as a patient registration form if the participant is newly enrolled onto the project, or a visit request form. When we receive a request to perform an off-site visit, we allocate the visit to a Research Nurse. The Research Nurse needs to live within travelable distance of the patient (some fly across states in the US), and must have been trained on the project, with all project documentation completed.
Every day I check the project tracker to see if any visits have been requested, that need couriers booking or RNs allocated to them. This is an ongoing task, and as more patients see how wonderful off-site visits are, the more couriers we book!
We have our weekly team catch up in the morning, passing on any information we have gathered over the past week that might be helpful. It is a really nice time to catch up with the team and get to know each other. We have a great team and enjoy working together and supporting each other.
I check my project inbox and can see we have received an email from an RN allocated to the project. Unfortunately, they are ill and will not be able to complete the visit. I contact the RNPM and Recruitment team to find out if there is another nurse in the country that could cover the visit. Meanwhile I check the visit request date against the Protocol’s Schedule of Events and can see that the visit requested falls within the visit window and is due in a weeks’ time.
I hear back and a new Illingworth RN has just been onboarded in the country that I need and would be suitable to work on my project. Brilliant, I am given the thumbs up to reach out to the RN with training documents, and to arrange a training session with the RNPM.
Again, I am checking my trackers for visit updates and potential bookings.
Well, this RN is super speedy. They have read the training documents and have emailed me back to say they understand the Project and what is required of them during the visit. They have also agreed to go to site on Friday to meet the Principal Investigator and study team and will sign the Delegation Log then. Following the study training session with the RNPM in the afternoon I update our training tracker.
Today is a busy day, I compile all the RN’s training documents, including their CV and GCP, and send them to site for them to review. At the same time, I check my tracker to see if any couriers need booking for upcoming visits and yes, they do. We also have a client call this afternoon with the RNPM, to discuss the project.
We have heard back from the RN, and the visit is booked for in a weeks’ time, and following the study protocol, it is within project window. The visit is a simple blood draw, and the RN needs a courier to be booked to pick up the blood sample and take it to the lab for analysis. We book the courier and ask the RN to double check the booking, just to make sure its correct. We must ensure that the visit is going smoothly, so we have lots of processes in place, and we use our project trackers every step of the way.
We check that the RN has the equipment that they need, and if they do not, we send a request to the Equipment Coordinator, and mark it as ‘urgent’.
The Equipment Coordinator quickly gets the equipment boxed up, with the help of an RNPC if needed, and it gets shipped out to the RN in time for the visit. The RNPM and I check the tracker and make sure that all visits over the weekend and next week are booked in. I also check back in with the new RN to make sure they are happy with their visit next week, letting them know that the equipment is on its way. They have just let me know that they don’t have a car, and so will be taking public transport. I log into our travel company’s website and get that booked for them. I send the site an email reminding them to send us back a fully signed copy of the delegation log, when they do this, the off-site nursing visit can go ahead!
After a busy week, I message my team mates to say, ‘have a nice weekend’ and log off.
An Illingworth Mobile Research Nurse's week
Illingworth's Research Nurses offer a service which helps to take the clinical trial to the patient, aiming to make the overall clinical trial experience much easier for patients. Illingworth's Nurses operate on a near global scale to ensure we can offer patient centric trials to even some of the most isolated patient populations. All Research Nurses are highly trained, qualified and experienced in pharmaceutical, healthcare, biotechnology and medical device industries, across a range of different therapeutic areas. In the example of a week below we feature one of Illingworth’s full-time Research Nurses who covers London and the South East area.
It’s 9am and my working day has started. I have a Site Initiation Visit (SIV) this afternoon and so I do some reading of the study protocol in preparation. The study is oncology related; as the research nurse treating the patients, I have a huge protocol to come to grips with before the study starts recruiting patients. At 12:30 I leave for the underground for the hospital. The SIV starts at 1.30pm but I don’t want to take any chances and be late. Just as well because the train board displays delays on the train and next one is 10 minutes late. Arrive at the meeting venue and meet the CRAs in the reception area. The SIV progresses well, meeting the rest of the team and ironing out the recruitment pathway. I am taken on an orientation around the facility and I meet other staff I will come across whilst working at the hospital.
I have a home visit provisionally scheduled for today; but my patient may be going into hospital for treatment optimisation. I receive a text from the patient letting me know he will be in hospital for 5 days, so I cancel the appointment and immediately contact the research nurse at the hospital to confirm the team there will take the required blood sample within protocol specified window. Once that is done I set out to the other Hospital 15 minutes walk away, where I have a part-time contract to manage a study database. I have a weekly teleconference with my colleagues; the Research Team Manager and the other research nurses. During the teleconference I give an update on the previous day’s SIV and on my other projects and listen to updates from the other members of our team. Following that, I email my training requests for the new project and I spend the rest of the day working through medical notes and patient visit forms to update the database.
Early start for a home visit to collect a blood sample, car booked for 9.30am. As I’m driving down the A13 towards the M25, I see that the traffic on the opposite side of the road is not moving and a jam is forming, so I decide there and then to use a different route on my return otherwise I will be stuck in traffic unnecessarily. Arrive at patient’s home, ring head office to check in as per policy and then proceed to go and collect the blood. After finishing the visit I ring to check out with head office and get on the road; blood has to be processed within 2hrs of collection. Use the A2 back into London to avoid the traffic jam I saw earlier. Back at the home office, I ring the courier and arrange for a collection as soon as possible, they told me collection would be 1.5hrs later. Centrifuge the blood and complete paperwork, pack the sample and set aside for the courier. Whilst waiting, I decide to read through the protocol of another study I will be working on. Once the courier collects the sample, I make my way to the hospital to work on the database for a couple of hours.
Today is a busy day, I have an appraisal meeting with my manager late afternoon. Before I go, I need to do as much work on the database as possible because the CRA gave us a deadline for all the data for the study patients to be up to date. It is lovely to meet with the Research Nurse Team Manager, as we are all field based, though we speak on the phone regularly we make the most of face to face catch up time. The appraisal goes well, we catch up briefly then I leave. What a long day but all is well that ends well!
I don’t have any appointments today, which is good because I have to catch up on the administrative side of my work. I have emails to reply to, training dates to follow up on, catch up on the protocol and ICH-GCP study. Before you could say Bob’s your uncle the day is passed and its 5pm, working week over.
Patient Concierge Coordinator
An Illingworth Patient Concierge Coordinator week
The role of Patient Concierge Services Coordinator is a busy and varied one, which can provide interesting and unique challenges. The main purpose of the role is to lessen the impact of clinical trial participation on patients and their families, be that through arranging reimbursement of expenses, managing door-to-door travel requirements, or both. The level of support provided is flexible and patient led, and is available globally.
At the core of PatientGO® is a focus on providing a positive patient experience which, alongside insights I have gained into the lives of clinical trial patients and their families, motivates and drives me. The smallest gestures or actions can make a big difference to someone participating in a clinical trial, who usually have to cope with many challenges and difficulties for a variety of reasons. Being the person that can make a positive difference to someone’s day is, for me, one of the things that makes this role worthwhile.
Mondays always starts with checking emails and project trackers to look for any updates that need urgent attention.
I also attend internal project meetings to review progress, agree next steps and actions required, and agree who will follow up on the items identified.
Included in emails received is upcoming visit schedules for patients on a clinical trial. I add this information for each patient to the PatientGO® app (which is designed to support the service offered by the Patient Concierge Services team) so they can view the details and request travel, if required. I take care when adding this information in the knowledge it will be read by the patient and make it as clear as possible for them. The schedule is also added to our tracker to help with our planning and oversight of the different travel elements that need to be booked for each visit.
I receive confirmation of travel bookings for another patient and add the information to the PatientGO® app for the patient to view and access their tickets for travel. As with the visit schedule, this information is read by the patient in the app, so I take care when adding it. Again, our tracker is also updated.
I am expecting information to book travel for a patient’s return journey back home post-visit and follow this up with the site they are attending. I would like to make this booking and confirm the details in the app as soon as possible so the patient knows the arrangements are in place. Ideally, we do this as far in advance as possible to reduce any anxiety the patient may have about this.
I book an interpreter for a call scheduled on Friday.
Expenses have been submitted from several patients since yesterday, so I check them and approve them for reimbursement where possible. A couple need follow up with the patient to verify some of the details before they can be approved.
A response has been received from the site contacted yesterday about the patient’s journey back home, so I move forward with booking the travel, add the details to the app, update the visit tracker, and confirm the booked travel to the site.
I attend an introductory call with a new patient. This is an important part of supporting a patient as it allows us to start building a relationship with them and understand their specific needs.
We have our weekly team meeting.
On checking our tracker, I notice a couple of upcoming visits for which the patients have not requested travel, so follow up with them. I take this opportunity to ‘check in’ with them, make sure everything was OK with the travel for their last visit and ask if any changes need to be made for the next travel arrangements.
I attend a hand-over call for a new project and follow up on the usual actions triggered by this call. I also start to familiarise myself with the project details and relevant documentation.
More expenses have been submitted from patients, and I am able to approve all of them for reimbursement after checking them.
App account requests have been received from new patients, and I complete the registrations after carrying out our verification process.
I attend an introductory call with a new site. This includes the interpreter booked earlier in the week as the team are in a different country and do not speak English. Establishing a good relationship with sites is key to us working together to ensure patients have the support they need.
I complete a final sweep of project trackers for an overview of visits the following week and the arrangements in place, particularly focussing on the early part of the week to ensure everything is in place.
My week ends with a regular project update call with a client.