IBA

Institut biostatistiky a analýz, s.r.o.

Collaboration on international projects; ad-hock assignmentsWe are looking for external contractors based in Hungary, Romania, Bulgaria, Poland, Austria, Portugal, Italy, Lithuania, Latvia, Spain, Greece, or Serbia.Role Overview Freelance CRA & Regulatory Affairs Suppor is an outsourced, countrylevel expert acting as the local extended representative of the Institute of Biostatistics and Analyses (IBA). The role combines: Clinical Research Associate (CRA) / monitoring activities, and Handson preparation and submission of documentation to Ethics Committees (ECs) and Regulatory Authorities for studies involving medicinal products (CT, NIS) and medical devices (CI, PMCF) Key Responsibilities CRA / Monitoring Activities Support feasibility, site selection, and site activation Perform Site Initiation Visits, monitoring visits, and study closeout Ensure compliance with: ICHGCP Study protocols and SOPs National and EU regulations for medicinal products and medical devices Review source data and essential documentation Support sites with inspection and audit readiness Regulatory & Ethics SupportChecks, submit, track, and maintain documentation to: Ethics Committees (ECs) National Regulatory / Competent Authorities Support for documentation management:Initial approvals Substantial and nonsubstantial amendments Notifications, safety updates, and administrative changes Study closure and final reporting Ensure compliance with: National legislation EU regulatory frameworks (e.g. EU CTR, MDR/IVDR where applicable) Requirements for clinical research involving medicinal products and/or medical devices Required Profile Education University degree in: Life Sciences, Medicine, Pharmacy, Public Health, Biomedical Sciences Experience 3-5+ years of experience in CRA positionsHandson CRA/monitoring experience Direct experience with EC and Regulatory Authority submissions Experience in studies involving medicinal products and/or medical devices Knowledge of: ICHGCP and National and EU clinical research regulations Skills & Languages Ability to work independently as a freelancer Strong organization, communication, and compliance mindset Fluent English (written and spoken) Fluent local language of the assigned country Freelance Requirements Registered freelancer / independent contractor in the given country Ability to invoice for services Availability for longterm, multiproject collaboration Willingness to complete IBA qualification and onboarding What IBA Offers Longterm freelance partnership Participation in international clinical and realworld research projects Role as a trusted countrylevel CRA and regulatory submissions expert in medicinal product and medical device Research Is the Institute of Biostatistics and Analyses the right place for you?you want to be part of a company focused on project management, data analysis and management, research, and the development of innovative technologies in the field of healthcare and life sciences - then yes, absolutely.We are a spin-off of Masaryk University, working with leading global experts to deliver “healthy data” that often influence what new treatments are adopted in patient care. You’ll gain valuable insights into the development of medicines and medical devices.Contactvolfova@biostatistika.cz