A Senior Data officer’s role within a Research setting forms an important part of any Research trial. Any patient specific information taken in regards to a specific trial must be documented; this includes blood results, vital signs, body temperatures etc. Once documented, this information must then be entered onto an online database for analysis, and it is here the Data Officer plays a part. It is the Data Officers role to enter all clinical trial data onto these online databases, ensuring that all data is complete, conformant and 100% accurate. Should any information required be missing, the data officer will then liaise with the Research Nurses, assistants and Consultants to rectify this until all data is complete. It is a role which requires meticulous attention to detail and a high standard of accuracy.
At present, a typical day starts at 8 am when we attend morning handover. Here, all staff including Research Nurses, Assistants, Data Officers, Laboratory Technician, Recruitment Officer and the Clinical Managers meet up and discuss study activity for the day. Study visits and clinic visits are allocated and staff are reminded of any meetings or training scheduled for the day. Today I have been informed there are a number of studies which will require data entry once the study visit is complete, after which I will then deal with queries – these are findings by study monitors whereby data is either missing or incomplete/non conformant. While I wait for the patients to arrive, I will check through my emails. Email is the preferred method of communication within the CRF, and I will check these daily to see whether I have received any updates for specific trials, amendments to current protocols or trial specific training. This morning I have an email inviting me to a new Clinical Trial database, for which I will have to do specific training for, and a message from 1 of the study monitors reminding me to look over a number of queries raised. Study monitors are individuals who quality check all trial data for accuracy and completeness, and should there be any questions surrounding this data, the monitor will raise a query, which the Data Officer will respond to, and attempt to resolve. This is a continuous process to ensure trial data is always as up to date and accurate as possible.
Once the patient visits for that day have finished, I will then collect the relevant patient files from the Research Nurse, and enter in all information taken from that patient onto the online database. This will then be QC’d by my colleague afterwards, whilst I will QC any data that my colleague has entered to ensure all data has been entered correctly.
Recruitment is a large part of clinical trials, and as such, part of my role as data officer involves entering patients onto our C4C database. This is a database where potential volunteers who are interested in Research have consented to have their details kept for any upcoming clinical trials they may be eligible for. I will enter all details onto this database, again ensuring accuracy at all times, and this will then be used by the Research teams when recruiting for future trials.
Finally, in the afternoon, I have been informed that a study monitor will be attending the unit. As part of my role, it is my responsibility to ensure all relevant files and documents are ready and available for when the monitor arrives. Once these files are ready for the monitors visit, I will remain on hand for anything the monitor will need, and will sit down toward the end of the day to resolve any outstanding queries that can be dealt with that day.
What do you enjoy most about being a Senior Data Officer?
There are many things I like about the role, most notably, due to the nature of the work, constant learning and development of skills and study knowledge is required, which means you literally do learn something new every day! I find the background knowledge of the studies fascinating, and the constant variety of different trials means there is always something interesting happening. It is a role that can be very challenging, but with the right application, also extremely rewarding.
What is the hardest part of your job?
Due to new trials coming through the unit, I initially found it difficult to keep up with the amount of new information that was required to learn. However, over time, I have become more familiar with how clinical trials run, and this has made it easier to adapt to the ever changing and high pressure environment of a Clinical Research Facility.
What advice would you give to somebody considering being a Senior Data Officer as a career?
My advice would be to give it a try as it can be extremely rewarding and fulfilling. Although challenging, it is a role that offers scope for personal development, enables you to learn new skills, and provides a fascinating insight into the world of clinical trials.