The world of clinical research is changing fast, and the skills needed to succeed in 2025 will be a step above what we’ve seen in the past. With technology advancing and regulations shifting, hiring managers must ensure their teams stay ahead of the curve. To help you build a team that’s ready for the challenges ahead, I've highlighted the key skills that will drive success in the coming year. Let’s dive in!

1. Regulatory Awareness and Adaptability

Regulations are the foundation of clinical research. They ensure trials are safe, ethical, and meet scientific standards. Without them, patient safety and trust would be at risk, and the credibility of results could suffer. Staying up to date on regulatory changes, therefore, is a must for any clinical research team. Here's what hiring managers need to know for 2025.

Informed Consent Requirements

The U.S. Food and Drug Administration (FDA) recently proposed guidance to align its informed consent requirements with the Office for Human Research Protections (OHRP). The goal is to make consent forms clearer, enabling trial participants to better understand the purpose, benefits, and potential risks of the study. Changes are set to go into effect come early 2025.

Key Takeaway: Look for candidates who are familiar with these new guidelines and can adapt consent forms to make them clearer for participants.

Diversity Action Plans

The FDA has proposed draft guidance requiring Diversity Action Plans (DAPs) in certain clinical trials. The goal is to address disparities among underrepresented groups by setting clear enrollment targets by age, sex, race, and ethnicity. Clinical research teams will play a key role in developing strategies to meet these goals. The guidance will apply to Phase 3 drug trials and pivotal device studies starting in late 2025.

Key Takeaway: Look for candidates experienced in recruitment strategies to help meet diversity goals in clinical trials.

Transitioning to Clinical Trials Information Systems

By January 31st, 2025, all ongoing clinical trials in the European Union must transition to the Clinical Trials Information System (CTIS). This change aims to ‘strengthen Europe as a top spot for clinical research’ by simplifying trial approvals and oversight. Resources like guidance materials and training are available to help professionals adapt to the new system.

Key Takeaway: Focus on candidates with experience in regulatory systems like CTIS or those eager to learn through available training and materials.

2. Proficiency in Emerging Technologies

New technologies are changing clinical research, making trials smarter and more accessible. These tools are driving faster, more accurate insights for researchers, while also opening doors for diverse patient populations. Here’s a look at a few technologies and tools reshaping clinical trials that your teams can benefit from mastering.

Electronic Clinical Outcome Assessment (eCOA) Improvements

eCOA tools make it easier to collect and manage patient data digitally. They replace paper forms with user-friendly apps or devices, allowing patients to report outcomes in real-time. As a result, researchers are able to get faster, more accurate insights while simultaneously making the process simpler for participants.

Key Takeaway: Target candidates with experience in eCOA tools to streamline trials and improve patient accessibility.

Decentralized Trials (DCTs)

DCTs bring clinical trials closer to patients by using remote monitoring and virtual setups. Instead of requiring participants to travel to trial sites, they can simply join from home or local clinics.

Key Takeaway: Look for professionals who have conducted decentralized trials to expand patient reach.

Artificial Intelligence (AI)

AI is transforming clinical research by analyzing data faster than ever. It can predict trial outcomes, identify patient trends, and even help design better studies. For researchers, AI means smarter decisions and more efficient trials.

Key Takeaway: Look beyond traditional channels to find AI experts who can transform your clinical research approach.

3. Building Strong Relationships

Clinical research doesn’t happen in isolation. Building strong relationships is key to ensuring your trials run smoothly. Although, building good relationships cannot be achieved without proper communication. Here’s where hiring managers should focus to foster these critical connections.

Internal Communication

Look for candidates skilled in communicating with site staff, including sponsors, principal investigators (PIs), research coordinators, medical writers, and biostatistics teams. Clear internal communication ensures tasks are aligned and trials stay on track.

External Collaboration

Successful trials depend on strong external partnerships. Hire professionals who excel in collaborating with external stakeholders, whether it be study participants, IRBs, regulatory authorities, or advocacy groups. These connections are critical for addressing challenges and maintaining momentum in complex trials.

Setting Your Clinical Team Up for Success

As clinical research evolves, so must the teams driving it. By focusing on these core skills, you can build a workforce ready to tackle whatever 2025 has in store. If you’re looking to expand your clinical research team for the coming year, but don’t know where to start, consider getting in touch with our team here. Our clinical research support teams excel in finding the right talent to help you navigate the complexities of tomorrow’s trials with confidence and precision.