The life of a Clinical Research Professional (CRA) can sometimes be difficult to summarise as no day of the week is the same. However, that is what I like about my job, as each new day brings its own learning experiences and thus constantly encourages me to develop myself personally and professionally. Read more: Example of a career path: being a CRA – PACE (pace-cr.com)
I am currently working on two studies on vaccines in Africa. These are phase IV studies and Phase IV trials, also referred to as “therapeutic use” or “post-marketing” trials, are observational studies performed on drugs that have been approved by Health Authorities to 1) identify less common adverse reactions, and 2) evaluate cost and/or drug effectiveness in diseases, populations, or doses similar to or markedly different from the original study population. Read more here: Interventional Studies (pharmalys.com); Observational Studies (pharmalys.com)
Through these studies, I currently work with infectious hospital staff, but my job has led me to work in various therapeutic areas, like respiratory diseases, gastroenterology, and endocrinology. Here is a snapshot of some of the key activities I have been responsible for over the past week (or so)…happy reading!
My responsibilities as a CRA when in the Office
My tasks when I am at the office encompass administration, study management, and communication responsibilities.
Some of my administrative activities are to write confirmation letters before the visit to site, write visit reports on the conclusion of the visit to clinical research sites as well as draft follow-up letters. In conclusion, filing the documents collected from monitoring visits and maintaining study files. I also prepare the study documents for the shipment of the investigational product to the sites; I maintain study-specific trackers and organise logistics for monitoring visits (e.g. travel arrangements).
My responsibilities in terms of study management consist of (i) preparing recruitment summaries for sponsor-led teleconferences, (ii) reviewing protocol deviations,(iii) localising study-specific documents for local submissions, (iv) coordinating local submissions, and preparing site contracts for final review (pre-study tasks), (v) preparing contract amendments for signature and (vi) planning for monitoring visits.
I am also in charge of communication with the site staff. It means that I have to regularly respond to study-specific requests/queries from sites (by e-mail and telephone); follow up on the resolution of open action items from previous monitoring visits; contact sites to review recruitment progress and provide study protocol training to site staff (by telephone). Read more: Learn more about Clinical Research – PACE (pace-cr.com)
My activities as a CRA when in the field
First of all, when I am not at the office I travel! Being a CRA means traveling regularly to monitor sites. In Europe, my journeys can take 1 to 2 days for routine monitoring visits, depending on their location (locally, further away, or abroad). In Africa, my journeys are longer, lasting sometimes one week, as traveling is not as easy as in Western countries and because the number of patients included in the studies is often higher than in Europe.
During site monitoring, I ensure adherence to the currently approved study protocol and ICH-GCP guidelines, which are international ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials that involve the participation of human subjects. I review informed consent forms and adverse events/serious adverse events; I perform source data verification; I verify drug accountability/dispensing logs and drug storage requirements; I identify protocol deviations; I review the investigator site file; I check the study supplies; I encourage patient recruitment, and I identify and resolve site issues.
I am also responsible for training activities, like providing study and e-Case Report Form (CRF) training to site staff and helping the new CRAs to familiarise themselves with the site and monitoring activities required for the study. Finally, I’ll discuss with the site staff the findings of the monitoring visit and review the status of any open action items/eCRF queries from the previous monitoring visit. Read more: Learn more about Clinical Research – PACE (pace-cr.com)
As you can see, my job allows me to have a variety of different activities and responsibilities, working within hospitals and other healthcare environments, with direct contact with site staff. Today’s experience can be like this but other days can throw up different activities with various challenges. In conclusion, as a clinical research professional, my primary objective is to facilitate the production, collection, and management of data within clinical studies, and beyond this, I am proud and happy to participate in better people’s health! Read more: Clinical research: an exciting career path – PACE (pace-cr.com)