CRA ensuring success of clinical trials

Ulla Aresvuo works as a clinical research associate, or CRA for short, at the Medfiles Clinical Services unit. In her role as CRA, it is Ulla’s task to make sure that the rights and well-being of those participating in clinical trials are protected. In addition, she ensures that the reported study data are accurate and complete and that the study is conducted according to the study protocol, good clinical practice (GCP) and the applicable legislation.

Ulla graduated as Bachelor of Engineering in Bio and Food Technology in 2017, specialising in biomedicine, with studies in gene technology and immunology. She first started in the industry some ten years ago and has worked at Medfiles for 1.5 years.

Ulla Aresvuo CRA

Special expertise in cancer research and medical devices

The majority of Ulla’s assignments are related to cancer research, in which she has over the years accumulated extensive expertise. Ulla also has plenty of expertise in medical devices. She has completed a recruitment training by HealthTech Academy, in which her studies focused on EU and global legislation and the ISO 13485 quality system related to medical devices. In her previous positions, Ulla has worked with medical devices as a CRA and in product development and quality management.

According to Ulla, the work of a CRA is all about managing the big picture while also keeping an eye out for the tiniest details.

“A clinical trial is always a huge undertaking with many things to consider. I work with some dozen studies at the same time. And when patient safety is at stake, accuracy is key. It is vital to notice the smallest things at the monitoring visits. I consider my ability to manage the big picture as well as my precision and organisation skills my greatest assets,” Ulla says.

“When working with clinical studies, it is crucial to stay up to date with the current requirements. There is always something new to learn, and constantly updating and developing my competence is an integral part of my work,” Ulla continues.

Wide range of tasks within clinical trials

Ulla’s days at Medfiles are versatile, with different tasks in every stage of a study.

Before a study can be started, it must have a clear goal and a research plan called the protocol. The study protocol is an extensive document, describing the course of the study, procedures and test performed on study subjects, quality assurance in the study as well as how the results will be analysed and reported. The protocol is the basis for creating many kinds of documents, both electronic and paper versions, for collecting data from the study subjects and the study site,” Ulla says.

Her task is to prepare study documents, such as the information leaflets and informed consent forms that are given to the study subjects.

Clinical trials on drugs or clinical investigations on medical devices require a positive opinion from the authorities as well as from an ethical committee. A part of the job is to prepare and review the required documentation.

“However, this is just about to change, because as of 31 January 2023, all new clinical drug trials in the EU and EEA countries must be submitted through the European CTIS portal. In other words, applications will no longer be submitted separately to the ethical committee and the applicable authority,” Ulla says.

In addition to study preparations, Ulla’s work includes seeking suitable study sites and investigators and assessing their suitability. Ulla collects CVs and the required study certificates from the investigators, manages enquiries sent to and from the study sites and participates in site qualification visits together with the project manager.

A big part of Ulla’s work are the monitoring visits to the study sites. In fact, she has monitored studies carried out at university hospitals, central hospitals and private clinics all across Finland.

“Preparing for monitoring visits includes a thorough reading of the study protocol and the monitoring plan. Before the visit, there are also other instructions to be read and understood and advance preparations to be made, sometimes including remote monitoring visits,” Ulla adds.

At the visits, Ulla checks that the data collected for the study matches the patient information. A major part of monitoring is ensuring patient safety, for example by checking that all adverse events detected in the study have been reported. In addition, Ulla evaluates the ability of the site to conduct the study, for example in terms of available resources and observing the protocol.

After the visit, Ulla writes a monitoring report, the extent of which varies greatly depending on the study. In addition, a follow-up letter is sent to site, containing observations about missing documentation and any issues to be fixed, as necessary.

Once the last study subject has had the last visit at the study site, the site can be closed.

The close-out phase includes discarding any excess investigational medicinal products in an appropriate manner. It must also be ensured that all open issues have been resolved and study data and needed documents have been correctly collected. The trial master file and investigator’s site file must contain all the required documentation so that the study could be repeated when necessary. Finally, all study documentation is archived for a set period of time,” Ulla says.

Ulla’s other tasks include acting as the contact person between the study sponsor and the study site. In addition, she is involved in many internal projects at Medfiles as well as in writing standard operating procedures (SOPs).

Meaningful work and competent colleagues

“I have really liked working at Medfiles. One reason is that I have had the opportunity to work with cancer research: it has always been my dream. In addition to the work being meaningful, the best part of my work at Medfiles is my colleagues. Our clinical services team is fantastic. My home office at Medfiles is in Tampere, and also the Tampere office team is really nice,” Ulla says.

Ulla loves the variation in her daily work and the individual tasks. In addition, she appreciates the changing scenery: she gets to work with different people in all kinds of environments: at home, at the office and at the study sites all over Finland.

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