In-house CRA I

TL;DR

In-house CRA I (Clinical Research): Providing comprehensive support to clinical study sites and project teams with an accent on regulatory compliance, site documentation, and data management. Focus on maintaining trial master files, tracking study milestones via CTMS, and ensuring adherence to ICH-GCP guidelines across multiple clinical research projects.

Location: Must be based in Serbia, Hungary, Poland, Romania, or Slovakia

Company

hirify.global is a global clinical research organization dedicated to accelerating the development of new therapies.

What you will do

• Act as the primary point of contact for study sites, addressing inquiries and managing study supplies.
• Maintain and organize site-level data in the Trial Master File (TMF) to ensure audit readiness.
• Track study milestones and site activities using the Clinical Trial Management System (CTMS).
• Assist in the collection, review, and distribution of essential investigator site documents.
• Support data entry verification in EDC systems and facilitate database closure procedures.
• Coordinate with study teams to ensure compliance with ICH-GCP and local regulatory requirements.

Requirements

• Must be based in Serbia, Hungary, Poland, Romania, or Slovakia.
• Bachelor’s degree in a business, scientific, or healthcare discipline.
• Proficiency in English (verbal and written) is required.
• Advanced knowledge of Microsoft Office (Outlook, Word, Excel, PowerPoint).
• Strong attention to detail and ability to work independently in a remote environment.
• Ability to travel as needed for site support.

Culture & Benefits

• Opportunity to work in a professional, team-oriented clinical research environment.
• Support for professional development and learning of ICH-GCP and regulatory standards.
• Flexible remote work environment.
• Commitment to equal opportunity and inclusive hiring practices.