Freelance CRA & Regulatory Affairs Support (only for individual project contract)
Collaboration on international projects; ad-hock assignments
We 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, country‑level 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
- Hands‑on 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 close‑out
- Ensure compliance with:
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- ICH‑GCP
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- Study protocols and SOPs
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- 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 Support
- Checks, submit, track, and maintain documentation to:
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- Ethics Committees (ECs)
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- National Regulatory / Competent Authorities
- Support for documentation management:
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- Initial approvals
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- Substantial and non‑substantial amendments
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- Notifications, safety updates, and administrative changes
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- Study closure and final reporting
- Ensure compliance with:
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- National legislation
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- EU regulatory frameworks (e.g. EU CTR, MDR/IVDR where applicable)
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- 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 positions
- Hands‑on CRA/monitoring experience
- Direct experience with EC and Regulatory Authority submissions
- Experience in studies involving medicinal products and/or medical devices
- Knowledge of: ICH‑GCP 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 long‑term, multi‑project collaboration
- Willingness to complete IBA qualification and onboarding
What IBA Offers
- Long‑term freelance partnership
- Participation in international clinical and real‑world research projects
- Role as a trusted country‑level 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.
If you’re interested,
please respond to this position by submitting the contact form along with your résumé.