We were intrigued to hear the story behind a clinical research nurse from a low/middle income context publishing a new practical book for clinical researchers so asked her some questions:
1. Tell us a little about how you started your career in clinical research as a nurse and your journey to your current role
I started my career in clinical research at an early phase clinical trial site in George, South Africa in 2004, first as an ad hoc/sessional nurse then progressing to Study Coordinator for 3 years. I subsequently became the Manager of Clinical Planning, and the process laboratory (5 staff) and line manager for the clinical trial assistants (5 staff). I participated in the conduct of various first-in-human (FIH) trials (5) and other Phase 1 trials on Parkinson’s Disease, restless legs, alzheimers, schizophrenia, osteo arthritis, rheumatoid arthritis, prostate cancer, diabetes, COPD, asthma, TB, HIV, hypertension, and various skin disorders.
When this unit closed I joined an antimalarial drug FIH trial at the University of Cape Town (UCT) before taking up a position as Clinical Project Manager at a late phase trial site. However, when a senior position came up again at UCT I re-joined as Snr Project Manager and now Clinical Operations Manager – Pharma trials at the UCT Clinical Research Centre. In the new year I will be joining a Pharmaceutical company as national internal auditor as well as site manager of one of their sites in Cape Town.
2. Where would you advise a nurse interested in working in a clinical research capacity to start?
The best way is to start at the bottom as a Research Nurse! During this time make sure you experience all aspects of the conduct of the trial i.e. regulatory, ethical and other approval submissions, processing and shipment of biological samples, maintaining the Investigator Site Files, preparing and attending Site Initiation meetings and trial start-up. This learning curve will be your responsibility and the best way to learn is to get involved. Your first Good Clinical Practice (GCP) course will not mean much as you would not understand most of the terminology and abbreviations. So re-visit your GCP guidelines often and eventually it will make more sense.
3. What motivated you to write your book “A Comprehensive and Practical Guide to Clinical Trials”?
Most of the time clinical trial staff will start their careers halfway through a clinical trial. The pace is fast and intense with attention to detail vital for success. We could not find any book that told the research story from the beginning to the end. Lots of bits and pieces, but nothing in total and no practical examples. The team at the UCT Clinical Research Centre then made the decision that we would write this story to assist fellow colleagues to “see the bigger picture”. Our accomplishment is not in writing the book, but will come later when it is used within industry and academia to assist researchers in delivering quality data on time.
4. What are the main challenges for nurses working in a clinical research role in your context?
Good computer skills are vital to be a successful study coordinator. Planning skills and paying attention to detail is a huge challenge with the fast pace. I find it frustrating that most clinical staff do not pay much attention to protocol specific details - reading a protocol once is never enough! The protocol should be revisited for visit-specific details prior to each visit. It is important also to understand the 'why' behind doing certain activities in a certain way all the time, and always be aware of the GCP guidelines. What works in hospitals and clinics in general does not necessarily work when you conduct clinical research.
Thank you Brenda for being an inspiration to other clinical research staff, including those working is low and middle income settings, to share your practical experiences by publishing this book