Norwich Clinical Trials Unit

There are a variety of roles within the Norwich Clinical Trials Unit. Please choose from the staff interviews below to find out more about a particular role.

    Trial Manager               Trial Assistant              Trial Statistician            Data Assistant

   Dr Nick Leavey              Glenn Harden                 Sue Stirling             Katharine Goodall

Interview with Trial Manager Dr Nick Leavey

What do you do?

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.

Interview with Trial Assistant Glenn Harden

What do you do?

I’m a trial assistant at Norwich Clinical Trials Unit. I work primarily on the Prepare-ABC trial which is concerned with the effects of pre and post-operative exercise on post-operative morbidities and quality of life in colorectal cancer patients across the UK. My day-to-day tasks include recording numbers of patients who have volunteered for the trial, ensuring accuracy of information in the database, answering queries from recruiting hospitals, sending out supplies to centres and supporting the Trial Manager in any other work that comes up.

What skills and qualifications do you need to be a trial assistant?

Administrative skills, with a high degree of organisation and the ability to multitask are essential in the role as you are always trying to manage several different tasks at once. A scientific background is not essential, as the role does not require any specialised scientific knowledge, although a background in biology would be of benefit to understand some of the background of the trials.

What’s the most interesting aspect of your role?

I find the database management aspect of the trial most interesting because I enjoy checking the data for completeness and liaising with the research practitioners at each of the different recruitment centres to ensure that we have up-to-date and accurate data. This is essential in order to assess the primary outcome of the project, and by raising queries and having them answered, I also get to learn more about the trial.

What is the potential for career development?

The next step up is the trial manager position, and there are training courses that teach the skills and knowledge required for this. Within the NCTU, trial assistants get hands on experience in aspects related to running a trial so this is excellent training and can act as a stepping stone if someone is interested in becoming a trial manager.

What do you like about working in a CTU?

The team in the CTU are from a wide variety of backgrounds, and are friendly and good humoured which creates a very pleasant working environment. They are also very knowledgeable and supportive so that, as a trial assistant, I know that I have their breadth of knowledge to draw upon if needed when responding to questions or if I am unsure about anything. Working on a clinical trial which aims to improve the quality of life for people is also something that I enjoy being part of.

Interview with Trial Statistician Sue Stirling          

What do you do?

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.

Interview with Data Assistant Katharine Goodall          

What do you do?

I am a data assistant within the Data Management team at NCTU. This means I work closely with trial teams to help develop and support clinical database management systems so that all our trials can be run successfully and efficiently. I am responsible for ensuring that system specification and release documentation is complete and accurate, and I am also involved with the internal testing of systems that we have developed (e.g. producing user test systems) and with the development process, for example of eCRFs in REDCap, our clinical database development platform.

What skills and qualifications do you need to be a data assistant?

Attention to detail, being organised and seeing the big picture, alongside experience of working within clinical trials and an aptitude to learn new skills and technologies quickly is essential. Being a good communicator is also helpful - I often liaise with people with different levels of technical ability. A degree in a numerate discipline is useful but not essential.

What’s the potential for career development?

Gaining experience & learning new technical skills such as HTML & SQL are essential before progressing, and in terms of my own career path, the next logical step would be the position of database programmer, a post which requires in-depth programming experience.

What do you like about working in a CTU?

Working as part of a team, and having the opportunity to meet and work with a variety of people.  I also enjoy working in so many different areas of research, and varying disease and therapeutic areas. It’s also important for me to have a job that is working on something that is ultimately beneficial to people.