Freelance Clinical Research Associate (CRA)
Medical Diagnostics – Initial Clinical Study
Contract Type: Freelance / Independent Consultant
Start Date: Late May
End Date: End of September
Workload: ~0.1 FTE (approx. 8 hours per week)
Location: Spain (Lab based in Barcelona)
Language: Spanish (fluent) & English (professional working proficiency)
Project Overview
We are seeking an experienced freelance Clinical Research Associate (CRA) to support an initial clinical trial study for a client operating in the medical diagnostics space. This is an early-phase study and represents the client’s first clinical trial, requiring a hands-on and methodical CRA with strong regulatory and site experience in Spain.
The study will be conducted at a single laboratory site in Barcelona, with a limited number of on-site visits across the contract duration.
Key Responsibilities
- Act as CRA support for the client’s first clinical study in medical diagnostics
- Preparation for and conduct of on-site monitoring visits, including:
- Site Initiation Visit (SIV)
- Interim Monitoring Visit (IMV)
- Close-Out Visit (COV)
- Ensure study conduct is compliant with:
- Protocol requirements
- ICH-GCP
- Local Spanish regulatory and ethical requirements
- Review and verification of essential documents and site files
- Support site staff with study-related queries and documentation
- Timely reporting of visit outcomes, findings, and follow-up actions
- Act as an interface between the site and sponsor/project team
Required Experience & Skills
Must-have:
- Proven experience working as a Clinical Research Associate (freelance or permanent)
- Prior experience on clinical studies in Spain
- Fluent Spanish (spoken and written)
- Solid understanding of ICH-GCP and local regulatory requirements
- Experience conducting on-site monitoring visits
- Comfortable supporting an initial / first-in-human or first-client trial setup
Nice-to-have:
- Experience in medical diagnostics or IVD studies
- Prior experience supporting sponsors with limited clinical trial history
On-Site Requirements
- 3 on-site visits to the laboratory in Barcelona across the contract duration (SIV, IMV, COV)
- Remaining activities performed remotely
Engagement Details
- Approximately 8 hours per week (0.1 FTE)
- Freelance / consultancy engagement
- Flexible working pattern aligned with study needs