What Does It Take to Be a GCSA Clinical Research Site Assessor?

From Compliance to Excellence

With patient safety and data integrity being principal to clinical research, it goes without saying that all site units must focus on compliance with ICH-GCP. However, well-run clinical studies are underpinned by more than legal and regulatory compliance. Synergistic working between stakeholders, in addition to focus on participant experience and client relationship takes a site from good to great.

Behind well run sites are a complex system of processes, people, and day-to-day business operations, that need to work quietly and efficiently in the background to keep everything running smoothly. This is where the GCSA Certification process comes in.

About GCSA

The GCSA Certification process is focused on seven business operating domains that ensure a well-run organization: Governance, Workforce, Business Strategy, Patient Engagement, Feasibility, Study Start-up & Initiation, Study Management, Operations & Close Down.

To achieve Certification, organizations undergo a rigorous, but supportive process that includes taking a site/site network of any size and maturity level through a comprehensive process to achieve GCSA Certification – the global quality standard for clinical research sites.

Unlike other certification processes, the GCSA team works alongside sites providing support and expertise where needed to ensure that all units fill any identified gaps to achieve GCSA Certification.

The Role of the GCSA Site Assessor

GCSA Site Assessors are intrinsic to the site assessment and certification process. The role requires a solid understanding of business operations within the context of a clinical research site setting in addition to a sharp eye for detail, an enquiring mindset to seek out evidence, and objectivity. A friendly, but professional and supportive approach is also paramount to ensuring trust and cohesive working with client teams.

At IAOCR how we go about our work and interact with clients is equally as important as what we do. Our aim is to help improve quality across the industry, and we can only achieve that if we are helpful and approachable as well as diligent.

At a high level, GCSA Site Assessors evaluate the effectiveness and efficiency of clinical research sites. They examine policies, procedures and other documentation, speak with site staff, analyse survey results, and identify areas of high performance and opportunities for differentiation.

Why Business Processes Matter

Well designed and efficient business operations are essential to being easy to work with and for, and to enabling true participant centric experiences. This ensures greater attraction and retention of participants, workforce, and clients.

Good, embedded processes help to prevent problems. They are essential to reducing risk and reducing cost. They also provide a firm platform for growth and continuous improvement. GCSA Site Assessors shine a light on how effectively and efficiently sites are working and provide insights that make a real difference.

Growing Demand for Assessors

Since launching in 2023 GCSA Clinical Research Site Certification has been rapidly adopted across the globe. Being a GCSA Assessor provides a great opportunity to work with different types of sites and site networks in different countries, and to add meaningful value as part of IAOCR’s ever growing clinical research best practice community.

With demand for GCSA Certification growing across the globe, IAOCR always welcomes contact from people that are interested in finding out more about becoming a GCSA Site Assessor. IAOCR provides a full onboarding programme of training, support, oversight and ongoing development and best practice sharing.

If you’re interested in learning more, please contact Sarah Everitt, Chief Quality and Client Officer via info@iaocr.com.