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!
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.
What is the role?
The Medical Imaging team bridge the gap between Medical Illustration departments in hospitals and clinical research, offering a customised clinical trial imaging service to suit each study’s requirements. We are members of and operate under the Code of Practice set out by the Institute of Medical Illustrators (https://www.imi.org.uk/), ensuring that we work within the regulations covering confidentiality, consent, data protection and good clinical practice.
Our underlying challenges are balancing clients’ requirements with the budget restraints, whilst endeavouring to constantly improve image quality and efficiency. This may seem boring or impossible, but every day is different, which keeps the role both challenging and interesting. On any day throughout a typical week any range of the following tasks will be repeated, shared throughout the team or even take complete priority, if required:
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.
Clinical Research Associate
The role of a CRA at Illingworth Research is very varied and includes many different tasks, in addition to the ‘standard’ CRA role. I say ‘standard’ CRA role, as I mean with many companies, being a CRA is limited to; site visits, including pre-study visits, initiation, interim monitoring, and close-out visits, and report and letter preparation. Although I am employed as a CRA and perform regular site visits across all types of studies, I have been involved in tasks such as business development, including review of budgets, preparation of monitoring and communication plans, assisting with preparation of staff meetings including presentation of topics, training of company staff and identification of KOLs.
- Check emails at home & call with a colleague about the new study.
- Gather laptop, documents, and suitcase and drive to the airport.
- Meet colleague at the airport and travel to Germany.
- Check emails and outstanding site actions from last week.
- Arrive at the site at 0830 and meet study nurse and PI.
- Start review of eCRF against source data.
- Train new study nurse on eCRF.
- Discuss data entry timelines with the study nurse.
- IMP accountability including a review of temperature logs.
- Discuss protocol deviations with the PI.
- Fly back to the UK.
- Weekly TC at 9 am for another study & provide monitoring update.
- Draft follow-up letter and report.
- Prepare and review text for the company website.
- Respond to emails.
- Prepare COV presentation for another study.
- Review budget for a potential new project.
- Meet with training coordinator regarding staff training meeting.
Clinical Trial Administrator
Supporting the smooth running of research
The role of a Clinical Trial Administrator (CTA) can be quite varied depending upon the study drug and the stage within the trial. CTA’s also need to adapt depending upon the involvement and requirements of the client company.
Here we speak with Andrea Pierce one of the CTA’s here at Illingworth Research. “I really enjoy the variety of the roles and the rewards of being a part of the clinical trial from start to finish of that study phase.” We join Andrea during the start-up phase of a study she was working recently. Focusing on progressing both regulatory and ethics submissions.
- 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.