Research Pharmacists - Roles & Responsibilities
Ever wondered what it entails to be a Research Pharmacist? What skills do you need? What uses do research pharmacists have in the world of clinical research? How does one ‘become’ a research pharmacist and what exactly does a research pharmacist do?
A lot of the answers to these questions are still being defined, as clinical research and Pharmacy is an ever-growing and developing relationship.
Pharmacy as a profession has been revered as reputable and respectable as a career in a medical field. It is four years of grueling studying, followed by a year’s worth of training either in hospital, community pharmacies, or pharmaceutical industries. If you were lucky enough, you managed to bag a cross-sectional training year which included a mixture of two sectors.
I remember whilst I was studying for my Masters in Pharmacy and even whilst doing my year training (pre-registration year) in a hospital setting, there was little mention of clinical trials or clinical research. I was simply not aware of the possibilities that clinical research can present to pharmacists.
It’s odd thinking back now, how little exposure you had to clinical trials, unless you were lucky enough to enter pharmaceutical industry. Although even that was restricted to lab work only, rather than utilizing the learning and understanding gained during the 4 years of Pharmacy. The same was for my pre-registration year, I felt it was completely unrelated to my teachings at University, and rather felt like a complete new learning curve (a very steep one!).
This exact feeling is what I went through when I entered the world of clinical research back in 2012. It was a big leap of faith and a jump into an unknown territory. Before starting in research, of course I had some concept of what a clinical trial was, having avoided them as much as possible within the dispensary, as they involved numerous logs, special labels, and most of the time, a lengthy procedure that differed for every trial, and with time, I found out, with every trust!
Most NHS Trust within the UK are involved in research and clinical trials, with larger teaching trusts having more than 100 clinical trials on their portfolio. Some regional centres even specialise in specific disease areas such as paediatrics, surgical or neurology trials. Ideally, a dedicated clinical trials pharmacist and technician positions should be assigned to managing and running these clinical trials, however this does not seem to the norm across NHS hospitals in the UK. Several factors seem to contribute to the lack of pharmacy support for clinical trials, mainly the lack of expertise amongst pharmacy workers, but also the lack of funding available or set aside for clinical research.
Even this is baffling, considering most of the NHS hospital trusts visions or values include research in some form of wording. I’ve highlighted three as an example from the Trusts that I have worked in so far:
Generate world-class clinical research
Deliver the promises of the Biomedical Research Centre bid
Give as many of our patients as possible the opportunity to be part of research trials
Progress clinical academic appointments within UCL and other academic partners
Work with partners, including HSL, to develop academically linked, advanced diagnostics and embed genome testing
Improve utilisation of our clinical research facilities
Develop and encourage research opportunities for junior doctors, nurses and all other staff across UCLH
Great Ormond Street Hospital (GOSH)’s mission is to provide world-class clinical care and training, pioneering new research and treatments, in partnership with others, for the benefit of children in the UK and worldwide.
Across our departments and divisions we have a shared vision to produce world leading translational and patient-orientated research. We are always aspiring to develop new research and treatments across the breadth of paediatric specialities. Great Ormond Street Hospital for Children is fully committed to conducting high quality research in collaboration with our various academic and industry partners.
At GOSH, our research teams are consistently amongst the best in the world in their disciplines. Our highly skilled researchers, with the support of the entire Trust’s workforce, are using cutting-edge techniques and equipment to:
Develop novel and improved diagnostics for our patients and the wider population.
Pioneering innovative treatments and therapies for our patients.
Performing high quality clinical trials of academic and industry-led medicines and therapeutics.
Understanding and preventing the development and progression of childhood illnesses.
Evaluating at a multi-disciplinary level the impact and progression of disease and our interventions. and treatments, in partnership with others, for the benefit of children in the UK and worldwide.
Our three values statements are:
Patients first
Patients and families will be at the heart of what we do and their experience within the hospital, and their perception of the Trust, will be our measure of success.
Working together
Our clinical teams will provide services to patients and are crucial to our success. We have launched a leadership strategy that ensures our clinical management teams are engaged in the day-to-day management and governance of the Trust.
Always improving
Our growing reputation in research and development and our approach to education and training will continue to incorporate new ideas, technologies and greater efficiencies in the services we provide
This is obviously only a short selection of NHS Trust values and visions, but coming from big hospitals, it is clear that the NHS wants to be more part of clinical research and deliver research at its highest quality and safety. My previous article highlighted how pharmacy itself and pharmacist skills can enhance clinical research and why it is important to involve pharmacy (read it here). So I suppose the next logical question is, what does a research pharmacist really do?
Where to even start, there’s so much I can say in regards to what I do as a Research Pharmacist. Speaking to and collating several research Pharmacists point of views and job descriptions, I have found that there isn’t a ‘glove’ that fits all Research Pharmacists. What the job role entails will also differ which sector you work in. Each sector has a brief bullet point of roles and responsibilities. Obviously, if I had to list them all, this article would be far too long! So here’s a very brief summary of the jobs that a research pharmacist does. As you will see, the scope of the job of research pharmacists varies between different settings, but patient safety is at the centre of all sectors and is of utmost important in all aspects of research. The main difference between a research and a clinical pharmacist is the shift from a patient centred service for clinical pharmacists to a project-orientated task for research pharmacists.
A. NHS Clinical Trials Pharmacist
These are pharmacists who will be in charge of several aspects of clinical trial management and conduct within that particular NHS trust. The main role of a Research Pharmacist in this setting will be to ensure clinical trials conducted at site are as per regulations and that both safety and quality are taking into account.
Feasibility review drug handling
Contracts
Costing
Trial setup
Trial coordination
Storage
Clinical Screening and Checking
Dispensing (including aseptic preparation)
Destruction
B. Joint Research Office/Trial Unit Research Pharmacist
Myself being one and also working in a clinical trial unit, I can be certain that this particular role is varied and unfortunately cannot be explained very well. However the main role of this type of research pharmacist is to be able to act as the Sponsor pharmacist to help the research office or trial unit effectively, safely and start new clinical trials as per EU regulations. They must take into account both the sites, the regulatory body and the sponsor requirements in order to fulfil the scientific need of that particular clinical trial.
Sponsorship review
Costing
Contracts
Drug manufacture/sourcing
IMP expertise
Clinical Trial submission
Protocol and IB/IMPD review
Quality assurance, audits and inspections
Labelling and packaging
These are pharmacists working within the pharmaceutical industry, and this area is even broader in regards to what roles a pharmacist may do. Pharmacists can be active in a variety of departments such as, sales, marketing, scientific liaison, medical information, signatories, drug product manufacture, quality assurance, pharmacovigilance and many more.
Medical information
Scientific advisor
Pharmacology
Drug development
Pharmacovigilance
Publications
Drug supply and coordination
Labelling and packaging
As you can see from just the brief descriptions, the career opportunities and the amount of diversity across sectors as a research pharmacist is substantial. A career in research as a pharmacist is most definitely rewarding and an ongoing learning curve. As a pharmacist or pharmacy technician, a career in research pharmacy is limitless without strict boundaries, allowing you to pick and choose your strengths and adapt those to a career in research, whichever sector you desire.
How to start a career in research Pharmacy?
Have I whet your appetite into exploring a career in research pharmacy? Subscribe to my site and get notifications of future blog posts, and if you really are interested in embarking a career in research, get in touch info@cortexcl.com and explore the many training opportunities Cortex Consultancy offers to help you reach your career desires further as a research pharmacist or pharmacy team member.
