123pracovat

Longterm collaboration on international projects 

We are looking for external contractors based in Slovakia, Hungary, Romania, Bulgaria, Poland, Austria, Portugal, Italy, Lithuania, Latvia, Spain, Greece, or Serbia.

Role Overview 

The Country CRA & Regulatory Affairs Specialist (Freelancer) 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 Submissions 

• Checks, submit, track, and maintain documentation to:  

• Ethics Committees (ECs) 

• National Regulatory / Competent Authorities 

• Manage documentation for:  

• 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 clinical research 

• Handson 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.