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!

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.

Reviewing study images and providing feedback to several (hospital) sites nationally and globally, is part of managing the clinical trial imaging on a day-to-day basis. This image feedback offers site photographers the opportunity to improve during their next photography session, ensuring that images are taken consistently across all investigator sites, meeting the standardised criteria outlined within the Medical Imaging User Guides for that study. Different languages and busy clinical staff often mean that the first challenge for this regular but important task is to clearly explain the problems, then identify how they should be resolved, but without being perceived as patronising or condescending.

Equipment preparation ranges from configuring the submenus on an SLR camera before locking it down to flying to and from another country, installing CCTV equipment in a dedicated clinic room at a private clinical. The software required to capture high quality audio and visual having been tested, both at site and then back in the UK head office by colleagues.

The outbound flight was spent finalising the installation paperwork. During the return flight, a set of standard operating procedures (SOPs) relating to a new imaging process required checking and updating, prior to forwarding to Quality Assurance for their final review.

Those investigator site (hospital) staff planning on taking the study images require training very early in the morning as they are based in Japan, local research managers assist on the teleconference with any communication issues. We instigate the remote photography training sessions once the equipment is confirmed at site, this involves presenting slides and demonstrating how to operate the SLR camera along with its video functions, in accordance with the study specific User Guides.

All those site photographers trained are requested to submit a set of test images and video, captured in accordance with those user guides. These would then be quality checked and passed if they meet the required criteria, then allowing that individual to complete study imaging.

Having discussed with the Research Nursing division representative the specification for a study specific training video, time and equipment was scheduled to start filming. With the combined Medical Imaging skills and the specific knowledge of the Research Nursing team, it can take a full morning to successfully capture the study specific training video to support their nursing team.
Downloading and collating the clips into a draft video for the nursing project lead to review takes the remainder of the day. Later communication would be required from the Research Nursing division followed by the client prior to finalising for study distribution.

Business development (BD) Medical Imaging material requires updating, the task is to draft an imaging information flyer for both dermatology, ophthalmology and dentistry imaging. The material should be worthy of BD distributing at conferences or via social media, so be informative, succinct and visually appealing.

A meeting is set with BD regarding the possible use of animation in study material for a potential client. They wish to explain complex medical issues to children with the rare condition, so they may understand what the proposed clinical trial will involve.

Review and suggest amendments as required to a study specific budget, to be submitted as part of a proposal by the end of the week. From experience estimate how long certain tasks will take and research the costs of supplies to ensure accuracy where possible. If certain aspects are unknown, then an assumption based on best practise is clearly stated and the costing calculated accordingly.

• File new site-specific documents submitted by sponsor as per our filing matrix within an eTMF (Electronic Trial Master File).
• Weekly internal catch-up, good call all happy that everything is going smoothly. Couple of queries for sponsor which PM (Project Manager) is investigating.

• Liaise with sponsor regarding site documents wording to make appropriate for UK NHS site.
• Creation of an emergency contact card for the UK study site as per the Illingworth SOPs (Standard Operating Procedures).

Big day today... a new study protocol version is issued.

• Add new protocol and supporting amendments file to eTMF.
• Upload new documents to IRAS regulatory submission.
• Release these documents to site PI as per sponsors request.
• Work through IRAS submission carefully and amend elements which mention protocol and alter inclusion criteria as per protocol amendments.

• Sponsor weekly teleconference – depending on the sponsor’s request I’m not always required on these ones but with the new Protocol being issued, we felt it was important we were all 100% clear on the changes and the reasoning behind them.
• Take meeting minutes and preparing for PM and Sponsor approval.

• File meeting minutes following gaining approval from PM and study sponsor.
• Complete and submit my weekly hours worked on the study.