I’m currently managing two studies within dementia research. The PERFECTED WP3 trial is a feasibility study aimed at improving care delivered to older patients who fracture their hip and experience confusion whilst in acute hospital settings.
ASCRIBED is an observational study funded by Alzheimer’s Research UK and uses the unique opportunity provided by hip fracture operations undertaken via spinal anaesthesia to collect a cerebral spinal fluid (CSF) sample, to investigate the impact of acute systematic brain inflammation on the exacerbation of dementia.
Both of my current studies have completed their initial start-up phases and are now open for recruitment. The study start-up phase has been particularly rewarding within ASCRIBED, as I was able to make significant contributions to the current protocol, patient workbooks, database, and sample collection and processing procedures, as well as completing site selection and feasibility assessments and preparing submissions to regulatory and ethical bodies.
Now that both studies are up and running, I am primarily involved in their day-to-day management, acting as the first point of contact for participating sites. This includes:
Answering queries about patient eligibility;
Handling requests for study protocols/associated documents and procedures;
Arranging/presenting at Trial Management Group meetings;
Processing amendment submissions
Document and version control maintenance;
Trial promotion (e.g. sending out newsletters, managing study websites, visits to hospitals to provide training and deal with queries/issues relating to the study)
Scheduling Investigator meetings.
What skills and qualifications do you need to be a trial manager?
Being able to build and maintain effective working relationships with the different site teams is crucial to my role. As a trial manager, it is therefore essential to have really good communication and organisational skills. It is helpful to have specific therapeutic area knowledge, but this isn’t essential. Moreover, this role requires an ability to constantly prioritise and manage different workloads, whilst being able to delegate tasks to the trial assistant and work optimally within a team environment as well as independently.
Ideally you need a degree in science to be a trial manager. I have a BSc in Sports Sciences and an MSc in Sport and Applied Physiology, so it’s probably fair to say that I’ve had to learn a lot about clinical research during my career! After completing my Masters course, I started working at a contract research organisation as a Research Operations Assistant, before later progressing to a Site Monitor, Study Co-Ordinator and now Trial Manager.
What is the potential for career development?
We have two recently promoted Senior Trials Managers within the NCTU. As well as continuing to manage their own studies, they support the Operations Manager in the recruitment and development of trial managers and trial assistants and co-ordinate work allocated to operations staff.
What do you enjoy most about working at the NCTU?
There is a great mix of staff with different past experiences and areas of expertise, which makes the NCTU a really dynamic and engaging place to work. This has given me a great opportunity to learn from my colleagues and develop within my current role.
Everyone is incredibly approachable and I am really enjoying the level of clinical research exposure and responsibility that my current role provides.
I am the Trial Assistant for Prepare-ABC: a trial looking at supportive exercise programmes for accelerating recovery after abdominal surgery. I also work on other trials that are run from NCTU, including covering on trials when staff are on leave and helping out when workloads are high.
I undertake a variety of different tasks, which include arranging and conducting minutes for meetings, preparing materials that need to be sent out to sites, and monitoring trial data, as well as helping to write documentation, such as patient newsletters and trial working instructions.
What skills and qualifications do you need to be a trial assistant?
There are no formal qualifications required to be a trial assistant, although a science degree is helpful. I have an MSci in Geochemistry and a PhD in Isotope Geochemistry, but you don’t need a PhD to work in clinical trials. I had no medical experience when I started at NCTU but it was my first job after finishing my PhD, and I have learnt a lot just through working on the trials. The most important skills needed are good time management and excellent communication skills. You need to be able to work to deadlines, and be prepared to juggle between various ongoing tasks.
What is the potential for career development?
The next step is a trial manager role, so making the most of training opportunities in this area is important. Within the NCTU, trial assistants get the opportunity to help prepare for site initiation visits, and I have assisted in opening new sites to our trial. There are also training courses that teach the skills and knowledge required for trial management positions.
What do you like about working in a CTU?
The best thing about working here is the atmosphere. There is a great sense of teamwork and I really enjoy being part of an interdisciplinary research group working towards a common goal. I enjoy the challenge of juggling tasks across multiple trials and being given the responsibility to manage my own time. I also enjoy talking to the research staff at the sites and helping them with the trial, as this is an area of research I haven’t previously had a chance to see.
I have worked at Norwich Clinical Trials Unit for over two years as a statistician, and am currently involved in a variety of ongoing trials: two concerning respiratory conditions, one investigating exercise for bowel cancer patients prior to, and following surgery, and two concerned with elderly patients. I enjoy the challenge of being involved in trials with a range of study designs (individual & cluster randomised, two & three arm) and different therapeutic areas. Being involved in several trials means I need to have a close working relationship with many different people from a variety of backgrounds – something I really enjoy!
Involvement with a trial usually begins before the necessary funding has been obtained for the trial to proceed. For example I often check sample size calculations done by a more senior statistician at Norwich CTU, for inclusion in a trial funding application. Once trial data collection has started I monitor the quality of the data and discuss any queries with other members of the trial team. The safety and conduct of the trial is monitored regularly by an independent data monitoring committee and with supervision from a more senior statistician, one of my main roles is to produce reports summarising data collected so far, for the committee to review. When a trial is finished, and all data queries have been resolved, a final report of the full analysis is written.
It is important that the results from trials are shared with the wider community of medical researchers so a part of my work in the future will be to collaborate on writing papers for medical journals and presenting the results at meetings.
I am also a member of the Protocol Review Committee at Norwich CTU – this involves reviewing protocols for newly funded trials – from a statistical viewpoint this entails checking the detail provided for the sample size calculation, and that the planned data collection is sufficient to answer the research question(s).
What skills and qualifications do you have?
I have an undergraduate degree in Combined Studies in Science, which focussed especially on Mathematics and Biology, and a Masters degree in Medical Statistics & Information Technology. Good organisation and communication skills are essential for this job, in particular the ability to convey statistical ideas to the general public. It’s not necessary to have a medical background, but useful to have a general interest in medicine, especially current developments in medical research. My job at Norwich CTU has been my first experience of working on clinical trials, and I have received much support and help from statisticians and other staff members within the unit. I have also benefitted from the training opportunities available to staff within the Norwich CTU.
What’s the potential for career development?
I am hoping to start studying part time for a PhD in the next year or so, and I am currently thinking about possible ideas for this. A PhD will enable me to further my career as a statistician.
How do I apply?
We have jobs coming up regularly within the CTU.
Please check the UEA website for any further information.