The clinical research landscape is undergoing a huge transformation, and with it brings a shift in the role, responsibilities and skillsets of a CRA, presenting both an opportunity and a challenge to those in the clinical operations field.

Decentralised Clinical Trials (DCTs) are becoming increasingly common, which is redefining traditional roles within clinical research and introducing new ways of working. Here are the ways in which the push to decentralisation is set to reshape the role of CRAs and what this means for you.

The transition to remote data specialists

The move towards DCTs suggests that CRAs will increasingly operate as remote data specialists. Traditional on-site monitoring is giving way to remote methods that leverage technology to oversee trials from a distance. Reports suggest that up to 97% of sponsors now use software to review source data remotely. This trend indicates a significant shift in how monitoring is conducted in a modern trial setting.

Regulatory bodies issued guidelines as far back as the pandemic that relate to remote monitoring practices, providing recommendations to support remote source data verification.

Some trial designs already require their CRAs to adopt remote monitoring tools. This allows for access of real-time data, allowing for earlier detection of potential issues and more efficient trial oversight. Adoption of this tech and trial model reduces travel time and enables CRAs to focus on data quality and integrity from anywhere.

The emphasis on technical proficiency

With the adoption of electronic systems like eISFs, eTMFs, and remote monitoring platforms, proficiency in these tools becomes essential. Technological skills are therefore set to become a cornerstone of the CRA role, and they’re already a major factor that’s considered when hiring CRAs today.

Remote site monitoring is only becoming more and more common, and it’s easy to understand the appeal for sponsors, as CRAs on average are able to monitor close to 50% more sites when a decentralised model is applied.

Embracing tech is going to help you become more successful as a CRA in 2024, will enhance your efficiency, and allow you to manage more sites effectively.

The desire for virtual communication skills

As face-to-face interactions decrease, strong virtual communication becomes vital. Building and maintaining relationships with site staff remotely requires excellent interpersonal skills. Regular video conferences, prompt email responses, and proactive engagement help to build trust and collaboration in an increasingly remote setting.

CRAs will need to adapt their communication styles to ensure that site personnel feel supported and valued, despite the potential physical distance. Developing these skills are going to ensure you have smooth operations and can deploy effective issue resolutions.

The evolution into consultative partners

The CRA role is expected to become more consultative, shifting from routine monitoring to a focus on providing guidance and support to sites on protocol adherence and regulatory compliance. With increased involvement in proactive risk identification and offering solutions to prevent potential problems, you’re now expected to provide more strategic guidance and support sites in understanding complex protocols.

Helen Yeardley, Senior VP of Clinical Operations at ICON, explains there’s an opportunity for CRAs to transition to site “owners”, which involves taking more responsibility for site performance, understanding processes at a deeper level than ever before, and having comfort being the primary point of contact.

There’s ample opportunity for CRAs add value beyond traditional monitoring. This approach strengthens your skills making you more prepared for progression, whilst also enhancing trial efficiency.

Adaptability as a key hiring criterion

For those responsible for hiring, seeking candidates who are adaptable and tech-savvy will be increasingly important. The ability to learn new tools quickly and adjust to changing methodologies is a significant asset.

Investing in training programs helps develop these competencies. The introduction of remote CRA hubs, enabling CRAs to work closely with sites without traveling, highlight the need for adaptability and continuous learning.

The industry experiences a turnover rate of up to 29% for CRAs, and the inability to keep up with changing demands is often cited as a reason for this. Those that are able to showcase the ability to adapt and participate in continuous self-development will be most successful.

An increased focus on patient engagement

Decentralised trials often place participants at the centre. As such, CRAs are set to play a more direct role in patient engagement. This might involve things like coordinating virtual visits, managing patient-reported outcomes through digital platforms, and addressing concerns promptly.

It’s within the interest of sponsors and researchers to make trials as patient-centric as possible to reduce drop-outs. By ensuring that patients feel supported throughout the trial, as a CRA you’re able to contribute to higher retention rates and more reliable data collection.

The need to navigate increasingly complex regulatory guidelines

The integration of new technologies brings fresh regulatory challenges. In recent years there have been regulations released that relate to trial registry, good clinical practice, remote data handling and the use of social media for clinical trials.

As trial and the tech used to enable them progresses, new regulation will continue to be issued—CRAs will need to stay clued-up when it comes to data privacy, remote monitoring, and digital consent processes. Understanding these issues ensures that trials remain compliant and that data integrity is upheld.

Bringing it all together

The decentralisation of clinical trials is redefining the role of the CRA, introducing new responsibilities and requiring an updated, diverse skill set. Embracing tech, enhancing virtual communication, and adopting a consultative approach positions you as a CRA for success in this shifting environment.

As an employer, focusing on these areas can lead to increased effectiveness and a greater chance at trial success. For hiring managers, assessing adaptability, technical proficiency, and strong communication skills in candidates is what you’re going to need in order to build a team ready to thrive in the era of DCTs.

For further support in building your skillset as a CRA, or for support in strengthening your clinical research team, reach out to us today.