Who is included in the project team proposed by the CRO?

The project team on the CRO side is a group of specialized individuals who lead the study from the conceptual stage to the final report and database closure. The team composition is always tailored to the scale and complexity of the project to ensure a smooth, safe, and GCP-compliant course of the study for the Sponsor.
Project Manager (PM) - the central figure in the project, responsible for coordinating the entire team's work. The PM supervises the schedule, budget, recruitment, risks, and communication with the Sponsor and sites. They oversee IMP, central laboratories, sample logistics, shipments, equipment, and collaboration with external vendors. In cooperation with the QA Manager, the PM also ensures compliance with GCP, SOPs, and applicable legal regulations, prepares the team for audits and inspections, coordinates corrective and preventive actions (CAPA), reviews the quality of TMF/eTMF documentation, and implements quality standards and best project practices. Thus, the PM acts as a "quality guardian" at the operational level.
Clinical Research Associates (CRA) - specialists responsible for monitoring sites, data quality, protocol compliance, and patient safety. CRAs support site teams in their daily work and respond to issues that may impact recruitment or data quality.
Clinical Trial Assistant (CTA) - an essential administrative support role for the PM and CRA. The CTA is responsible for maintaining and updating TMF/eTMF documentation, preparing, verifying, and distributing documents to sites, managing logistics for monitoring visits, assisting with report preparation, checklists, summaries, and correspondence, and coordinating the flow of information between project teams. The CTA plays a key role in maintaining communication fluidity and documentation quality.
Start-Up Manager / Clinical Research Specialist - responsible for preparing the project: documentation for KB and URPL/CTIS, complete ISFs, contract negotiations, site activation, and information flow during the start-up phase.
Data Manager (DM) - prepares eCRFs, formulates logic for forms, sets up queries, and ensures data quality.
Statistician - prepares the Statistical Analysis Plan (SAP), analyses, reports, and supports the project during the planning and database closure phases from a statistical perspective.
Pharmacovigilance (PV) Specialist - monitors adverse events, handles SAE reports, prepares periodic reports, and ensures compliance with safety regulations.
Regulatory Affairs / CTIS Manager / Clinical Trial Registration Specialist - responsible for preparing, submitting, and updating regulatory documentation, communication with authorities, and handling RFIs.
Quality Assurance (QA) - supports the project with audits, inspections, quality reviews, CAPA, and documentation compliance — working directly with the PM and the operational team.
A well-chosen CRO team is not just a task executor but a partner who takes responsibility for the quality, safety, and smooth running of the project. If you would like to discuss the appropriate team for your study, feel free to contact us, and we’ll gladly advise on the best solution.